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1. The role of echocardiographic screening in reducing the burden of rheumatic heart disease in Latin America

Author

Manuel Urina-Jassir, Maria Alejandra Jaimes-Reyes, Daniela Urina-Jassir, Manuel Urina-Triana, and Miguel Urina-Triana

Subjects
rheumatic heart disease, heart valve diseases, echocardiography, early diagnosis, latin america, Medicine, Arctic medicine. Tropical medicine, RC955-962, Public aspects of medicine, RA1-1270
Abstract

The objectives of this article are to reflect on the rationale behind the use of echocardiographic screening for rheumatic heart disease and to provide key recommendations about steps needed to implement and improve echocardiographic screening programs in Latin America. Rheumatic heart disease remains a public health problem affecting mainly low-income and lower-middle-income countries and populations. Latin America is an area with economic inequalities, and the epidemiology of rheumatic heart disease remains largely unknown. Echocardiographic screening is useful for updating the epidemiology and providing early diagnosis of the disease. We discuss different approaches used in successful echocardiographic screening programs worldwide and in Latin America. We then identify the key elements needed to establish successful echocardiographic screening programs in Latin America, including increased awareness and involvement from multiple sectors (e.g. the community, health care professionals, scientific organizations and public health entities), identification of areas in need, development of a plan and structure that include different screening approaches, and how to ensure appropriate follow up for those who screen positive.

Published
2023
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2. Factors associated with frailty among older individuals with chronic diseases: A multicenter study

Author

María Victoria Quintero-Cruz, Mirary Mantilla-Morrón, Manuel Urina-Jassir, Yisel Pinillos-Patiño, Carmen Inés Quijano-Del Gordo, Walberto Buelvas, Luzdaris De Ávila-Quintana, Karin Cotes, and Miguel Urina-Triana

Subjects
Medicine (General), R5-920
Abstract

Objective: Frailty is a syndrome that predisposes older individuals to adverse health outcomes, such as disability, dependence, falls, hospitalization, post-operative complications, and poor health in general. This study aimed to identify factors associated with frailty in older people with chronic diseases in Colombia. Methods: A cross-sectional study was conducted with a nonprobabilistic sample of 230 older people (aged ⩾ 60 years) from four Colombian cities. Frailty was based on Fried’s phenotype (frail defined as having ⩾3 criteria). Comorbidities were classified based on Charlson’s Comorbidity Index and key questionnaires for activities of daily living (ADLs) were evaluated. Results: Most were female (57.8%) with a mean ± SD age of 71.9 ± 8 years. Among them, 27.4% were frail and 58.7% were prefrail. Female gender, age ⩾ 75 years, low educational and socioeconomic level, dependence on ADLs, and cognitive impairment were associated with higher odds of prefrailty/frailty. Conclusions: Prefrailty and frailty are common among older people with chronic diseases in Colombia. This syndrome is associated with social and health-related conditions, which should be addressed when providing care for these patients.

Published
2024
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4. Factors associated with coronary artery disease among people living with human immunodeficiency virus: Results from the Colombian HIV/AIDS registry

Author

Manuel Urina-Jassir, Andrés Felipe Patiño-Aldana, Lina Johana Herrera-Parra, Juliana Alexandra Hernández Vargas, Silvia Juliana Trujillo-Cáceres, Ana María Valbuena-García, Lizbeth Acuña-Merchán, Daniela Urina-Jassir, and Miguel Urina-Triana

Subjects
HIV, Heart disease risk factors, Coronary artery disease, Colombia, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: People living with HIV (PLWHIV) are at a higher risk of developing coronary artery disease (CAD). We aimed to assess the factors associated with CAD among PLWHIV in Colombia. Methods: We conducted a retrospective cohort study based on adults newly diagnosed with HIV, reported to the Colombian HIV/AIDS registry from 2018 to 2021. Baseline demographic and clinical characteristics were compared by age (

Published
2023
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5. Clinical, Microbiological, and Imaging Characteristics of Infective Endocarditis in Latin America: A Systematic Review

Author

Manuel Urina-Jassir, Maria Alejandra Jaimes-Reyes, Samuel Martinez-Vernaza, Camilo Quiroga-Vergara, and Miguel Urina-Triana

Subjects
Endocarditis, Latin America, Microbiology, Blood Culture, Echocardiography, Infectious and parasitic diseases, RC109-216
Abstract

Objectives: We aimed to describe the clinical, microbiological, and imaging characteristics of patients with infective endocarditis (IE) in studies from Latin America (LATAM). Methods: A systematic search through PubMed, EMBASE, LILACS, and SciELO from inception until February 2021 was conducted. We included observational studies that assessed adults with IE from LATAM and reported data on clinical, microbiological, or imaging characteristics. Data were independently extracted by 2 authors and the risk of bias was evaluated by study design with its respective tool. Findings were summarized using descriptive statistics. Results: Forty-four studies were included. Most cases were male (68.5%), had a predisposing condition including valve disease (24.3%), or had a prosthetic valve (23.4%). Clinical manifestations included fever (83.9%), malaise (63.2%), or heart murmur (57.7%). A total of 36.4% and 27.1% developed heart failure or embolism, respectively. Blood cultures were negative in 23.9% and S. aureus (18.6%) and the viridans group streptococci (17.8%) were the most common isolates. Most cases were native valve IE (67.3%) affecting mainly left-sided valves. Echocardiographic findings included vegetations (84.3%) and regurgitation (75.9%). In-hospital mortality was 25.1%. Conclusions: This is the first systematic review that evaluated the characteristics of IE in LATAM patients. A lack of multicenter studies reflects the need for these studies in LATAM.

Published
2022
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6. Ruta de atención y manejo de la dislipidemia en el paciente con síndrome coronario agudo: brechas y recomendaciones

Author

Álvaro J. Ruiz, Miguel Urina-Triana, Juan E. Gómez-Mesa, Andrés F. Buitrago, Gilberto A. Castillo, Luis E. Echeverría, Gilberto Estrada, Ángel A. García, Efraín Gómez, Daniel Isaza, Erika Martínez, Fernán Mendoza, Dora I. Molina, Alejandro Román, Clara Saldarriaga, Hernando Vargas, Luz C. Zárate, Etna L. Valenzuela-Plata, Juan P. Moreno, and Andrés F. Suárez

Subjects
Dislipidemia. Síndrome coronario agudo. Enfermedad isquémica del corazón. Lípidos. Enfermedad cardiovascular. Colesterol LDL., Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Objetivo: el síndrome coronario agudo es una importante causa de morbimortalidad en Colombia, con una alta carga en calidad de vida, muertes, impacto social y costos para el sistema. El control subóptimo de las dislipidemias tiene múltiples causas, entre ellas el uso inadecuado de las estatinas, la inercia terapéutica, la baja difusión y la adopción de las guías y protocolos de manejo, adicional a las barreras de acceso a la atención y a los medicamentos, y la falta de trazabilidad en la atención a partir del evento isquémico agudo. El proyecto “Ruta de atención y manejo de los lípidos en el paciente con síndrome coronario agudo” busca identificar las brechas en la atención clínica y el manejo de la dislipidemia en los pacientes con síndrome coronario agudo en Colombia, y plantear soluciones para cerrarlas. Materiales y método: se realizaron 178 encuestas a profesionales médicos en instituciones de todo el país, para conocer las pautas de manejo de los pacientes con dislipidemia en el paciente con síndrome coronario agudo. Un panel de 17 expertos analizó los resultados y definió las brechas entre la práctica clínica, la evidencia disponible y el manejo recomendado, y planteó recomendaciones para cerrarlas. Resultados y Conclusiones: este artículo muestra las principales brechas detectadas en el manejo de la dislipidemia en pacientes con síndrome coronario agudo en Colombia, y emite recomendaciones de manejo de la dislipidemia, coherentes con las necesidades y características del Sistema de Salud colombiano.

Published
2023
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7. Current Situation of Acute Rheumatic Fever and Rheumatic Heart Disease in Latin America and the Caribbean: A Systematic Review

Author

Maria Alejandra Jaimes-Reyes, Manuel Urina-Jassir, Manuel Urina-Triana, and Miguel Urina-Triana

Subjects
rheumatic heart disease, rheumatic fever, epidemiology, latin america, caribbean region, Diseases of the circulatory (Cardiovascular) system, RC666-701, Public aspects of medicine, RA1-1270
Abstract

Background: Rheumatic heart disease (RHD) disproportionately affects low-income and middle-income countries. Latin America and the Caribbean (LAC) have been less represented in scientific literature. We aimed to describe the epidemiology, burden and implemented screening and prevention strategies of RHD in LAC. Methods: We systematically searched PubMed, Embase, LILACS, and SciELO from 1990 to April 2021. Observational and experimental studies that described data on the epidemiology, burden, or prevention/screening strategies of RHD, regardless of age or language, were included. The risk of bias was assessed by previously published tools depending on their study design. Pre-specified data were independently extracted and presented by each topic (epidemiology, burden, prevention/screening). PROSPERO registration number: CRD42021250043. Results: Forty-eight studies out of 1692 non-duplicate records met the eligibility criteria. They were mainly from Brazil, observational in design, and hospital-based. Data on the epidemiology of acute rheumatic fever (ARF) was not recent (most before 2000) with studies describing decreasing incidence through the years. The prevalence of RHD was described in six studies, ranging from 0.24 to 48 per 1,000 among studies evaluating schoolchildren. Nine studies described data based on admissions, ranging from 0.04% to 7.1% in single-center studies. Twenty-four studies assessed the burden of RHD with most of them reporting mortality rates/proportions and complications such as the need for intervention, atrial fibrillation, or embolism. Six preventive strategies were identified that included educational, register-based, and/or secondary prophylaxis strategies. Three well-established echocardiographic screening studies in Brazil and Peru were identified. Conclusions: Most ARF/RHD research in LAC comes from a single country, Brazil where preventive/screening efforts have been conducted. There was a paucity of data from several countries in the region, reflecting the need for epidemiological studies from more countries in LAC which will provide a better picture of the current situation of ARF/RHD and guide the implementation of preventive strategies.

Published
2022
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9. The effect of comorbidities on glycemic control among Colombian adults with diabetes mellitus: a longitudinal approach with real-world data

Author

Manuel Urina-Jassir, Lina Johana Herrera-Parra, Juliana Alexandra Hernández Vargas, Ana María Valbuena-García, Lizbeth Acuña-Merchán, and Miguel Urina-Triana

Subjects
Glycated hemoglobin A1c, Diabetes mellitus, Comorbidity, Hypertension, Chronic kidney Disease, Obesity, Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Abstract Background Achieving an optimal glycemic control has been described to reduce the incidence of diabetes mellitus (DM) related complications. The association between comorbidities and glycemic control remains unclear. Our aim is to evaluate the effect of comorbidities on glycemic control in people living with DM. Methods A retrospective longitudinal study on data from the National Registry of Chronic Kidney Disease from 2014 to 2019 in Colombia. The outcome was poor glycemic control (PGC = HbA1c ≥7.0%). The association between each comorbidity (hypertension (HTN), chronic kidney disease (CKD) or obesity) and PGC was evaluated through multivariate mixed effects logistic regression models. The measures of effect were odds ratios (OR) and their 95% confidence intervals (CI). We also evaluated the main associations stratified by gender, insurance, and early onset diabetes as well as statistical interaction between each comorbidity and ethnicity. Results From 969,531 people at baseline, 85% had at least one comorbidity; they were older and mostly female. In people living with DM and CKD, the odds of having a PGC were 78% (OR: 1.78, CI 95%: 1.55-2.05) higher than those without CKD. Same pattern was observed in obese for whom the odds were 52% (OR: 1.52, CI 95%: 1.31-1.75) higher than in non-obese. Non-significant association was found between HTN and PGC. We found statistical interaction between comorbidities and ethnicity (afro descendant) as well as effect modification by health insurance and early onset DM. Conclusions Prevalence of comorbidities was high in adults living with DM. Patients with concomitant CKD or obesity had significantly higher odds of having a PGC.

Published
2021
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11. Impacto del aislamiento preventivo obligatorio en la actividad física diaria y en el peso de los niños durante la pandemia por SARS-CoV-2

Author

Harold Arévalo, Miguel Urina Triana, and Juan Carlos Santacruz

Subjects
COVID-19, Children, Isolation, Feeding, Physical activity, Overweight, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Resumen: Introducción: En Colombia, desde el 24 de marzo hasta el 31 de agosto de 2020, los niños y adolescentes estuvieron 162 días en total aislamiento preventivo obligatorio por la pandemia por COVID-19. Objetivo: Conocer y evaluar el comportamiento de niños y adolescente durante el período de confinamiento por Covid-19, para establecer las consecuencias sobre la actividad física y el aumento peso. Métodos: Se elaboró una encuesta virtual abierta realizada en la plataforma de encuestas de Google, dirigida a los padres, la cual estuvo conformada por 5 preguntas: 1. ¿Qué edad tiene su hijo? 2. ¿Cuántos minutos por día de actividad física realiza en casa? 3. ¿Cuántos minutos de pantallas (TV, computador, celular, videojuegos, etc.) ve su hijo al día? 4 ¿Cuántas horas duerme su hijo en la noche? 5. ¿Se ha elevado el peso corporal de su hijo(a)? ¿Cuánto? La encuesta se distribuyó en las bases de datos de la Asociación de Medicina del Deporte y de la Fundación Colombiana del Corazón a través de redes sociales, como WhatsApp, y correos electrónicos. Resultados: Se realizaron 1.139 encuestas virtuales. Se encontró que durante el período de aislamiento obligatorio el 75,2% de los niños no realizó los minutos recomendados de actividad física por la Organización Mundial de la salud (OMS), que el 82,8% superó el tiempo de 60 minutos frente a dispositivos electrónicos y que el 44% aumentó de peso. Conclusiones: En los períodos de confinamiento es importante diseñar estrategias y procesos educativos que promuevan en los niños estilos de vida que puedan conservar a futuro, cuando sean adultos. Abstract: Introduction: In Colombia from March 24 to August 31, 2020, children and adolescents spent 162 days in total mandatory preventive isolation due to the Covid-19 pandemic. Objective: To know and evaluate their behavior of children and adolescents during this period of confinement in order to establish the consequences on the physical activity and weight gain. Methods: An open virtual survey was developed on the Google survey platform, addressed to parents with 5 questions: 1. How old is your child: 2. How many minutes of physical activity at home do you do? 3. How many minutes of screens (TV, computer, cell phone, video games, etc.) her or she watch per day? 4. How many hours does he or she sleep at night? 5. Has your child's body weight increased? How much? This survey was distributed in the databases of the Association of Sports Medicine and the Colombian Heart Foundation through social networks such as WhatsApp and emails. Results: 1,139 virtual surveys were conducted. It was found that during the mandatory isolation period: 75.2% of the children did not perform the minutes of physical activity recommended by the World Health Organization (WHO), that 82.8% exceeded the time of 60 minutes versus to electronic devices and that 44% weight gained. Conclusions: In periods of confinement, it is important to design educational strategies and processes that promote healthy lifestyles in children that can be preserved in the future in adults.

Published
2020
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12. Cambios en el estilo vida de mujeres de raza negra con intervención educativa del programa 'Actúa con corazón de mujer'

Author

Sandra Camacho, Leany Blandón-Rentería, Juan C. Santacruz, Laura Tamayo, Miguel Urina-Triana, and Fernán Mendoza-Beltrán

Subjects
Cambios de comportamiento. Cultura de cuidado. Riesgo cardiovascular. Intervención poblacional., Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Introducción: a diario en Colombia mueren 60 mujeres por enfermedad cardiovascular y las mujeres de raza negra tienen mayor riesgo. Según la Organización Mundial de la Salud (OMS) estas muertes son, en su mayoría, prevenibles. El cuidado como estilo de vida es una intervención del programa “Actúa con corazón de mujer” de la Sociedad Colombiana de Cardiología y Cirugía Cardiovascular (SCC) y la Fundación Colombiana del Corazón (FCC). Objetivo: formar líderes para promover la adopción de comportamientos saludables. Método: se seleccionaron municipios con población de raza negra y compromiso de las autoridades locales. 395 mujeres fueron elegidas. La percepción del riesgo se midió con un instrumento adaptado por la FCC. La intervención educativa se dividió en cuatro sesiones en cada municipio durante cinco meses. Las participantes fueron formadas en toma de presión arterial; se utilizó la automonitorización de presión arterial (AMPA) para confirmar hipertensión y se incluyeron mediciones antropométricas y fisiológicas para calcular el riesgo cardiovascular y de diabetes. Resultados: Los resultados consolidados de los instrumentos y mediciones aplicados demostraron significativos aportes en reducción de riesgo cardiovascular, en razón de una nueva percepción de los peligros y de la incorporación de comportamientos saludables. Conclusiones: las mujeres aprendieron del cuidado. 90% reportaron percepción “ideal” del riesgo, hicieron promesas y adoptaron comportamientos tomando acción frente a sus factores de riesgo y más del 50% evidenciaron cambios en las medidas antropométricas. Los resultados demuestran que estrategias de educación, especialmente con líderes comunitarias, pueden ser de gran relevancia para la salud pública.

Published
2022
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13. Consenso latinoamericano para el manejo del riesgo residual cardiometabólico. Consenso realizado por la Academia Latinoamericana de Lipidología y Riesgo Cardiometabólico (ALALIP), con el aval de la Sociedad Interamericana de Cardiología (SIAC), la Sociedad Interamericana de Aterosclerosis (IAS) y el Colegio Panamericano de Endotelio (PACE)

Author

Carlos I. Ponte-Negretti, Fernando Wyss, Daniel Piskorz, Raul D. Santos, Raul Villar, Alberto Lorenzatti, Patricio López-Jaramillo, Peter P. Toth, A. Juan J. Amaro, Alfonso K. Rodrigo, Fernando Lanas, Miguel Urina-Triana, Jofre Lara, T. Osiris Valdés, José R. Gomez-Mancebo, Alfonso Bryce, Leonardo Cobos S., Adriana Puente-Barragán, Vladimir E. Ullauri-Solórzano, Félix A. Medina-Palomino, Alfredo F. Lozada, Maritza Duran, Percy Berrospi, David Miranda, Juan J. Badimon, J. José R. González, and Peter Libby

Subjects
Riesgo residual. Riesgo cardiovascular. Riesgo cardiometabólico. Enfermedad cardiovascular aterosclerótica. Inflamación. Trombosis., Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: Hypertension, hyperglycemia, dyslipidemia, overweight, obesity, and tobacco (smoking, chewing, and vaping), together with a pro-inflammatory and procoagulant state, are the main risk factors related to atherosclerotic cardiovascular disease. Objective and methods: A group of experts from the Americas, based on their clinical expertise in cardiology, cardiovascular prevention, and cardiometabolic (CM) diseases, joined together to develop these practical recommendations for the optimal evaluation and treatment of residual CM risk factors in Latin America, using a modified Delphi methodology (details in electronic TSI) to generate a comprehensive CM risk reduction guideline, and through personalized medicine and patient-centered decision, considering the cost-benefit ratio The process was well defined to avoid conflicts of interest that could bias the discussion and recommendations. Results: Residual risk reduction should consider therapeutic options adapted to specific patient needs, based on five treatment objectives: triglyceride-rich lipoproteins, inflammation, impaired glucose metabolism, high blood pressure, and prothrombotic status. Comprehensive control of all CM risk factors should be a priority to deal with this important public health problem and prevent premature deaths. The recommendations in this paper address the evidence-based treatment of CM risk and are intended for clinical application in Latin American countries.

Published
2022
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14. Statin associated adverse reactions in Latin America: a scoping review

Author

Manuel Urina-Jassir, Tatiana Pacheco-Paez, Carol Paez-Canro, and Miguel Urina-Triana

Subjects
Medicine
Abstract

Objectives We aim to describe the frequency and type of adverse drug reactions (ADRs) in patients on statins in published studies from Latin American (LATAM) countries.Design Scoping review.Methods A literature search was conducted in three databases (PubMed, EMBASE and LILACS) in addition to a manual search in relevant journals from LATAM universities or medical societies. A snowballing technique was used to identify further references. Randomised controlled trials (RCTs) and observational studies between 2000 and 2020 were included. Studies were considered eligible if they included adults on statin therapy from LATAM and reported data on ADRs. Data on ADRs were abstracted and presented by study design.Results Out of 8076 articles, a total of 20 studies were included (7 RCTs and 13 observational studies). We identified three head-to-head statin RCTs, two statin-versus-policosanol RCTs and only two placebo-controlled trials. The statin-related ADRs frequency ranged from 0% to 35.1% in RCTs and 0% to 28.4% in observational studies. The most common ADRs were muscle-related events including myalgia and elevated creatine phosphokinase. Other reported ADRs were gastrointestinal symptoms, headache and altered fasting plasma glucose.Conclusions We identified differences in the frequency of ADRs in both observational studies and RCTs from LATAM countries. This could be due to the absence of standard definitions and reporting of ADRs as well as differences among the study’s interventions, population characteristics or design. The variability of ADRs and the absence of definitions are similar to studies from other geographical locations. Further placebo-controlled trials and real-world data registries with universal definitions should follow.

Published
2021
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15. Efectos de un programa de ejercicio físico de 12 semanas en sujetos con revascularización coronaria o postangioplastia transluminal percutánea

Author

Mirary Mantilla-Morrón, Miguel Urina-Triana, Yaneth Herazo-Beltrán, and Daniela Urina-Jassir

Subjects
Enfermedad Coronaria, Rehabilitación, Ejercicio, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Objetivo: Determinar los efectos de un programa de ejercicio físico sobre las características antropométricas y la capacidad funcional postcirugía de revascularización coronaria o postangioplastia coronaria transluminal percutánea. Métodos: Estudio clínico no controlado, de antes y después, en 49 pacientes postcirugía de revascularización coronaria o angioplastia coronaria percutánea. El índice de masa corporal, perímetro abdominal, índice de cintura cadera, perímetro de la cadera y la capacidad cardiorrespiratoria a través de la caminata de los seis minutos fueron evaluados antes y al finalizar el programa de ejercicio físico. Este estuvo conformado por ejercicios aeróbicos continuos, de resistencia muscular, equilibrio y coordinación, durante 3 días a la semana, durante 12 semanas. Resultados: Con relación al perímetro abdominal en las mujeres cambió de 91,4 cm a 88,4 cm (p = 0,003) y en los hombres de 93,6 cm a 89,8 (p = 0,000). Se logró un incremento significativo de la distancia caminada de 330 a 436 metros (p = 0,000); del consumo energético de 3,4 a 4,1 MET (p = 0,000); y la máxima capacidad de absorber, transportar y consumir el oxígeno, de 12 a 14 ml/Kg/min. Conclusiones: El programa de ejercicio físico que fue utilizado en este estudio, pudo en todos los sujetos incrementar la capacidad cardiorrespiratoria y la tolerancia al ejercicio, y disminuir el perímetro abdominal. Los efectos benéficos obtenidos cambian el pronóstico de la enfermedad coronaria y disminuyen los factores de riesgo metabólicos.

Published
2017
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16. Ley matemática exponencial aplicada a la evaluación de la dinámica cardiaca en 18 horas

Author

Catalina Correa Herrera, Javier Rodríguez Velásquez, Signed Esperanza Prieto Bohorquez, Miguel Urina, Dharma Rodríguez, Isabel Echeverri-Ocampo, Farid Meléndez-Pertuz, Rafael Oyaga, and Esmeralda Guzmán

Subjects
ley, dinámica cardiaca, atractor, diagnóstico, Medicine (General), R5-920
Abstract

Antecedentes: la teoría de los sistemas dinámicos estudia la evolución de los sistemas. Mediante esta teoría y la geometría fractal se desarrolló una ley matemática de ayuda diagnóstica a los sistemas dinámicos cardiacos, que permite diferenciar entre normalidad y enfermedad, y la evolución entre los dos estados. Objetivo: confirmar la capacidad diagnóstica de la ley matemática exponencial desarrollada inicialmente para dinámicas cardiacas en 21 horas, para dinámicas evaluadas en 18 horas. Método: se tomaron 400 registros electrocardiográficos, 80 de dinámicas normales y 320 de dinámicas anormales. Se generó una sucesión pseudoaleatoria con el número de latidos/hora y las frecuencias máximas y mínimas cada hora; luego, se construyó el atractor de cada dinámica, para así calcular los espacios de ocupación y la dimensión fractal. Finalmente, se estableció el diagnóstico físico-matemático en 18 y 21 horas y se comparó con el diagnóstico clínico tomado como Gold Standard, obteniendo valores de sensibilidad, especificidad y coeficiente Kappa. Resultados: se encontraron valores de ocupación espacial en la rejilla Kp para normalidad entre 236 y 368 y para estados patológicos entre 22 y 189, lo que permitió diferenciar entre normalidad, enfermedad, y estados de evolución hacia la enfermedad en 18 horas. Se obtuvieron valores de sensibilidad y especificidad del 100% y coeficiente Kappa igual a 1. Conclusión: la ley matemática permitió dictaminar diagnósticos reduciendo el tiempo de evaluación a 18 horas confirmando así su aplicabilidad clínica.

Published
2019

17. Prevalencia del síndrome metabólico en hipertensos estadio I

Author

Daniela Urina-Jassir, Miguel Urina-Triana, José Balaguera-Mendoza, Luis Montenegro-Rolong, Manuel Urina-Jassir, and Manuel Urina-Triana

Subjects
Prevalencia, Síndrome metabólico, Hipertensión, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Introducción y Objetivo: En sujetos con hipertensión arterial sistémica recién diagnosticada es importante verificar la existencia de otros factores de riesgo para enfermedad cardiovascular para poder establecer estrategias para su óptimo tratamiento. Conocer cual es la prevalencia del síndrome metabólico en sujetos con hipertensión arterial sistémica estadio 1. Métodos: Estudio prospectivo, observacional, transversal, realizado durante un año en Bogotá, Medellín, Cali y Barranquilla en sujetos de ambos géneros, ≥ 18 años y ≤ 60 años con hipertensión arterial sistémica estadio 1 recién diagnosticada y sin tratamiento farmacológico. A todos los sujetos se les verificó la existencia de síndrome metabólico de acuerdo con el reciente consenso de la Federación Internacional de Diabetes, del Instituto Nacional del Corazón, Pulmón y Sangre, de la Asociación Americana del Corazón, de la Federación Mundial del Corazón, de la Sociedad Internacional de Aterosclerosis y de la Asociación Internacional para el Estudio de la Obesidad. Resultados: La prevalencia promedio de síndrome metabólico en la población total de hipertensos estudiada fue de 16.84%. En Cali fue de 28.8%, en Medellín fue 18.9%, en Barranquilla fue 12.5% y en Bogotá fue 11.4%. Medellín tuvo la más alta prevalencia en hombres (14.7%) y Cali la mas alta en mujeres (15.2%). Conclusiones: En los sujetos con hipertensión arterial sistémica de reciente diagnóstico se recomienda realizar una búsqueda sistemática del síndrome metabólico. En las ciudades estudiadas de Colombia existió gran variabilidad en la prevalencia del síndrome metabólico encontrada. Se requieren estudios para conocer en otras ciudades de Colombia cual es la prevalencia real del síndrome metabólico en sujetos con hipertensión arterial sistémica en el pais e implementar estrategias educativas para minimizar esta.

Published
2016
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22. Measurement, monitoring and knowledge of blood pressure: May Measurement Month, Colombia 2017

Author

Maritza Pérez, Miguel Urina-Triana, Jose L. Accini, S.M. Rueda-Quijano, Gregorio Sánchez, Paul A. Camacho, Patricio Lopez-Jaramillo, L.M. Gómez-Peña, Henry García, Juan José Rey, C.R. Galvis, I. Hernández, J.F. Gómez-Cuellar, Claudia Narvaez, María Eugenia Casanova, C. Mejía, L. E. García, Johanna Otero, Edgar Arcos, Gustavo Aroca, Dora I. Molina, and Everest

Subjects
Presión arterial, Promoción de la salud, Awareness, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Conocimiento, Risk factors, Hipertensión, Hypertension, Blood pressure, Internal Medicine, Health promotion, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, Factores de riesgo
Abstract

Digital, Objetivo Describir los hallazgos de la implementación de la iniciativa Mayo Mes de la Medición 2017 aplicada a población colombiana adulta con el objetivo de crear conciencia sobre la importancia de la medición, conocimiento y control de la presión arterial. Materiales y métodos Mayo Mes de la Medición es una encuesta transversal que sigue las directrices de la Sociedad Internacional de Hipertensión y la Liga Mundial de Hipertensión, que recoge información de factores de riesgo cardiovascular y mediciones de presión arterial. En Colombia su implementación fue liderada por la Fundación Oftalmológica de Santander (FOSCAL) y la Sociedad Latinoamericana de Hipertensión (LASH) con el apoyo de la Red Colombiana para la Prevención de las Enfermedades Cardiovasculares y Diabetes (RECARDI). Resultados Se recolectaron datos en 11 departamentos de 21.797 personas, siendo el 58,7% mujeres, la edad promedio fue de 40,5 ± 17,7 años. La prevalencia global de hipertensión arterial (HTA) fue del 20,8% (autorreporte de tratamiento antihipertensivo o toma de presión arterial sistólica [≥ 140 mmHg]). El 46,5% del total de hipertensos tuvieron cifras de presión arterial sistólica que les clasifica como no controlados (presión arterial sistólica < 140 mmHg) y el 26,4% no conocían su condición de hipertensos, los cuales en el presente reporte son considerados como los casos nuevos de HTA. Conclusión La prevalencia de presión arterial es alta en esta población adulta joven, en la cual el desconocimiento de la condición de HTA es también alta, y en aquellos que conocen su condición existe un porcentaje bajo de control de la HTA, resultados que demuestran la necesidad de implementar programas eficaces de detección de pacientes hipertensos y de establecer tratamientos estandarizados para mejorar el control de la HTA como una estrategia para la reducción de eventos cardiovasculares., Aim To describe the findings of implementing May Measurement Month 2017 in the adult Colombian population to raise awareness of the importance of blood pressure measuring, monitoring, and awareness. Materials and methods May Measurement Month is a cross-sectional survey that follows the directives of the International Society of Hypertension and the World Hypertension League, which gathers information on cardiovascular risk factors and blood pressure readings. Its implementation in Colombia was lead by the Santander Ophthalmological Foundation (FOSCAL) and the Latin American Society of Hypertension (LASH) with the support of the Colombian Network for the Prevention of Cardiovascular Diseases and Diabetes (RECARDI). Results Data was collected from 11 departments on 21,797 people, 58.7% of whom were female, with an average age of 40.5 ± 17.7 years. The overall prevalence of high blood pressure (HBP) was 20.8% (self-reported antihypertensive treatment or systolic blood pressure reading [systolic blood pressure ≥ 140 mmHg]). Of the total number of hypertensives, 46.5% had systolic blood pressure readings classified as uncontrolled (systolic blood pressure < 140 mmHg), and 26.4% were unaware that they were hypertensive who, in this report, we consider to be new cases of HBP. Conclusion The prevalence of (elevated) blood pressure is high in this young adult population, whose lack of awareness of HBP is also high, and HBP in those aware of their condition is poorly controlled. These results highlight the need to implement effective detection programmes for hypertensive patients and to establish standardised treatments to improve HBP control as a strategy to reduce cardiovascular events., Ciencias Médicas y de la Salud

Published
2020
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23. Latin American Consensus on management of residual cardiometabolic risk. A consensus paper prepared by the Latin American Academy for the Study of Lipids and Cardiometabolic Risk (ALALIP) endorsed by the Inter-American Society of Cardiology (IASC), the International Atherosclerosis Society (IAS), and the Pan-American College of Endothelium (PACE)

Author

José R Gomez-Mancebo, David Miranda, Alfonso Bryce, T Osiris Valdés, Miguel Urina-Triana, Adriana C Puente-Barragán, Peter Libby, Leonardo Cobos S, Patricio Lopez-Jaramillo, Raul D. Santos, Juan J. Badimon, Percy Berrospi, Carlos I Ponte-Negretti, Raul Villar, Alberto J. Lorenzatti, Fernando Wyss, Alfonso K Rodrigo, Alfredo Lozada, Jofre Lara, Vladimir E Ullauri-Solórzano, Félix Medina-Palomino, Daniel Piskorz, Fernando Lanas, A Juan J Amaro, Peter P. Toth, J José R González, Maritza Duran, and Masira

Subjects
medicine.medical_specialty, Latin Americans, Consensus, Riesgo cardiovascular, Enfermedad cardiovascular aterosclerótica, Cardiology, Riesgo residual, Overweight, Riesgo cardiometabólico, Residual risk, Special Article, Trombosis, Internal medicine, Medicine, Humans, Endothelium, Inflammation, Inflamación, business.industry, Public health, Enfermedad cardiovascular ateroscle- rótica, Thrombosis, Guideline, medicine.disease, Atherosclerosis, Cardiovascular risk, Cardiometabolic risk factors, Obesity, Lipids, United States, Latin America, Atherosclerotic cardiovascular disease, Personalized medicine, Inflam- mation, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Dyslipidemia
Abstract

Digital, Background: Hypertension, hyperglycemia, dyslipidemia, overweight, obesity, and tobacco (smoking, chewing, and vaping), together with a pro-inflammatory and procoagulant state, are the main risk factors related to atherosclerotic cardiovascular disease. Objective and methods: A group of experts from the Americas, based on their clinical expertise in cardiology, cardiovascular prevention, and cardiometabolic (CM) diseases, joined together to develop these practical recommendations for the optimal evaluation and treatment of residual CM risk factors in Latin America, using a modified Delphi methodology (details in electronic TSI) to generate a comprehensive CM risk reduction guideline, and through personalized medicine and patient-centered decision, considering the cost-benefit ratio The process was well defined to avoid conflicts of interest that could bias the discussion and recommendations. Results: Residual risk reduction should consider therapeutic options adapted to specific patient needs, based on five treatment objectives: triglyceride-rich lipoproteins, inflammation, impaired glucose metabolism, high blood pressure, and prothrombotic status. Comprehensive control of all CM risk factors should be a priority to deal with this important public health problem and prevent premature deaths. The recommendations in this paper address the evidence-based treatment of CM risk and are intended for clinical application in Latin American countries., Antecedentes: Un grupo de factores de riesgo cardiometabólicos (hipertensión, hiperglucemia, dislipidemia, sobrepeso, obesidad y tabaco (fumado, masticado, vaporizado), junto con un estado proinflamatorio y procoagulante, son los principales factores de riesgo relacionados con la enfermedad cardiovascular aterosclerótica. Objetivo y métodos: Basándose en su experiencia en cardiología, prevención cardiovascular y enfermedades cardiometabólicas, un grupo de expertos de las Américas se unió para desarrollar estas recomendaciones prácticas para la evaluación y tratamiento óptimos de los factores de riesgo cardiometabólicos residuales en América Latina, utilizando una metodología Delphi modificada con el objetivo de generar una guía integral de pautas para la reducción del riesgo cardiometabólico, mediante la medicina personalizada y la decisión centrada en el paciente teniendo en cuenta la relación costo-beneficio. El proceso fue bien definido para evitar conflictos de intereses que podrían sesgar la discusión y las recomendaciones. Resultados: La reducción del riesgo residual debe considerar opciones terapéuticas adaptadas a las necesidades específicas del paciente, basadas en 5 objetivos de tratamiento: lipoproteínas ricas en triglicéridos inflamación, metabolismo de la glucosa, presión arterial alta y estado protrombótico. El Control integral de todos los factores de riesgo cardiometabólicos debe ser una prioridad para hacer frente a este importante problema de salud pública y prevenir las muertes prematuras. Las recomendaciones de este documento abordan el tratamiento basado en evidencia del riesgo cardiometabólico y están destinadas a la aplicación clínica en los países de América Latina., Ciencias Médicas y de la Salud

Published
2022

24. Statin associated adverse reactions in Latin America: a scoping review

Author

Tatiana Pacheco-Paez, Miguel Urina-Triana, Carol Páez-Canro, and Manuel Urina-Jassir

Subjects
myalgia, Adult, medicine.medical_specialty, Statin, Drug-Related Side Effects and Adverse Reactions, medicine.drug_class, Population, Psychological intervention, Cardiovascular Medicine, Internal medicine, adult cardiology, lipid disorders, Medicine, Humans, In patient, Drug reaction, education, education.field_of_study, business.industry, General Medicine, internal medicine, Latin America, cardiology, Observational study, Statin therapy, medicine.symptom, Hydroxymethylglutaryl-CoA Reductase Inhibitors, business
Abstract

ObjectivesWe aim to describe the frequency and type of adverse drug reactions (ADRs) in patients on statins in published studies from Latin American (LATAM) countries.DesignScoping review.MethodsA literature search was conducted in three databases (PubMed, EMBASE and LILACS) in addition to a manual search in relevant journals from LATAM universities or medical societies. A snowballing technique was used to identify further references. Randomised controlled trials (RCTs) and observational studies between 2000 and 2020 were included. Studies were considered eligible if they included adults on statin therapy from LATAM and reported data on ADRs. Data on ADRs were abstracted and presented by study design.ResultsOut of 8076 articles, a total of 20 studies were included (7 RCTs and 13 observational studies). We identified three head-to-head statin RCTs, two statin-versus-policosanol RCTs and only two placebo-controlled trials. The statin-related ADRs frequency ranged from 0% to 35.1% in RCTs and 0% to 28.4% in observational studies. The most common ADRs were muscle-related events including myalgia and elevated creatine phosphokinase. Other reported ADRs were gastrointestinal symptoms, headache and altered fasting plasma glucose.ConclusionsWe identified differences in the frequency of ADRs in both observational studies and RCTs from LATAM countries. This could be due to the absence of standard definitions and reporting of ADRs as well as differences among the study’s interventions, population characteristics or design. The variability of ADRs and the absence of definitions are similar to studies from other geographical locations. Further placebo-controlled trials and real-world data registries with universal definitions should follow.

Published
2021

25. El plagio, su detección y como prevenirlo en la literatura médica

Author

Miguel Urina

Subjects
Building and Construction, Electrical and Electronic Engineering
Abstract

El plagio en la literatura científica médica desde antaño hasta nuestros tiempos es el peor flagelo que atenta contra la verdad que la investigación produce. Su aparición, a pesar de todos los esfuerzos por evitarlo, hace que debamos fortalecer y reflexionar sobre las medidas preventivas para desestimular esta práctica. En el presente artículo se realiza una revisión en Pubmed de las revisiones sistemáticas realizadas en los últimos 30 años para estudiar el plagio en la literatura mundial y, además, se presentan los tipos de plagio que pueden existir, sus definiciones y se pone de manifiesto cual sería la mejor forma de detectarlo, abordarlo y como implementar estrategias para prevenirlo. El control del plagio requiere de la acción combinada entre la educación, la detección y la prevención.

Published
2021
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26. Relation of lipoprotein(a) levels to incident type 2 diabetes and modification by alirocumab treatment

Author

J. Wouter Jukema, Josip Lukenda, Zuzana Motovska, Gregory Ducrocq, Victor Gurevich, Jacek Kubica, Miguel Urina, Peter Olexa, Andrzej Lubiński, Stefano Romeo, Francisco Marin, Siniša Car, Manjinder Singh Sandhu, Nattawut Wongpraparut, Yaroslav Malynovsky, Morten Bøttcher, Philippe Gabriel STEG, Andreas Zirlik, Konstantin Nikolaev, Anton Povzun, Dedrick Jordan, Gunnar Gislason, José Ramón González Juanatey, Michael Szarek, Anthony MAthur, Philip Aylward, Adrian Wlodarczak, and Andrzej Budaj

Subjects
Acute coronary syndrome, medicine.medical_specialty, Cardiovascular and Metabolic Risk, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, Antibodies, Monoclonal, Humanized, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Diabetes mellitus, Internal medicine, Internal Medicine, medicine, Humans, 030212 general & internal medicine, Alirocumab, Advanced and Specialized Nursing, biology, business.industry, PCSK9, Anticholesteremic Agents, Hazard ratio, Lipoprotein(a), medicine.disease, Treatment Outcome, Diabetes Mellitus, Type 2, biology.protein, Proprotein Convertase 9, business, Antibodies, Monoclonal, Humanized Anticholesteremic Agents* Diabetes Mellitus, Type 2* / drug therapy Diabetes Mellitus, Type 2* / epidemiology Double-Blind Method Humans Lipoprotein(a) Proprotein Convertase 9 Treatment Outcome, Lipoprotein
Abstract

OBJECTIVE In observational data, lower levels of lipoprotein(a) have been associated with greater prevalence of type 2 diabetes. Whether pharmacologic lowering of lipoprotein(a) influences incident type 2 diabetes is unknown. We determined the relationship of lipoprotein(a) concentration with incident type 2 diabetes and effects of treatment with alirocumab, a PCSK9 inhibitor. RESEARCH DESIGN AND METHODS In the ODYSSEY OUTCOMES trial alirocumab was compared with placebo in patients with acute coronary syndrome. Incident diabetes was determined from laboratory, medication, and adverse event data. RESULTS Among 13,480 patients without diabetes at baseline, 1,324 developed type 2 diabetes over a median 2.7 years. Median baseline lipoprotein(a) was 21.9 mg/dL. With placebo, 10 mg/dL lower baseline lipoprotein(a) was associated with hazard ratio 1.04 (95% CI 1.02−1.06, P < 0.001) for incident type 2 diabetes. Alirocumab reduced lipoprotein(a) by a median 23.2% with greater absolute reductions from higher baseline levels and no overall effect on incident type 2 diabetes (hazard ratio 0.95, 95% CI 0.85–1.05). At low baseline lipoprotein(a) levels, alirocumab tended to reduce incident type 2 diabetes, while at high baseline lipoprotein(a) alirocumab tended to increase incident type 2 diabetes compared with placebo (treatment–baseline lipoprotein(a) interaction P = 0.006). In the alirocumab group, a 10 mg/dL decrease in lipoprotein(a) from baseline was associated with hazard ratio 1.07 (95% CI 1.03−1.12; P = 0.0002) for incident type 2 diabetes. CONCLUSIONS In patients with acute coronary syndrome, baseline lipoprotein(a) concentration associated inversely with incident type 2 diabetes. Alirocumab had neutral overall effect on incident type 2 diabetes. However, treatment-related reductions in lipoprotein(a), more pronounced from high baseline levels, were associated with increased risk of incident type 2 diabetes. Whether these findings pertain to other therapies that reduce lipoprotein(a) is undetermined.

Published
2021

27. The Effect of Comorbidities on Glycemic Control Among Colombian Adults With Diabetes Mellitus: a Longitudinal Approach With Real-world Data

Author

Ana María Valbuena-García, Juliana Alexandra Hernández Vargas, Manuel Urina-Jassir, Lizbeth Alexandra Acuña-Merchán, Lina Johana Herrera-Parra, and Miguel Urina-Triana

Subjects
Adult, Data Analysis, Male, medicine.medical_specialty, Longitudinal study, Endocrinology, Diabetes and Metabolism, Comorbidity, Glycemic Control, Colombia, Diseases of the endocrine glands. Clinical endocrinology, Diabetes mellitus, Internal medicine, mental disorders, Medicine, Humans, Hypoglycemic Agents, Longitudinal Studies, Obesity, Prospective Studies, Registries, Glycemic, Aged, Retrospective Studies, business.industry, Incidence (epidemiology), Research, General Medicine, Odds ratio, Middle Aged, medicine.disease, RC648-665, Hypertension, Female, Kidney Diseases, Glycated hemoglobin A1c, business, Chronic kidney Disease, Kidney disease
Abstract

Background Achieving an optimal glycemic control has been described to reduce the incidence of diabetes mellitus (DM) related complications. The association between comorbidities and glycemic control remains unclear. Our aim is to evaluate the effect of comorbidities on glycemic control in people living with DM. Methods A retrospective longitudinal study on data from the National Registry of Chronic Kidney Disease from 2014 to 2019 in Colombia. The outcome was poor glycemic control (PGC = HbA1c ≥7.0%). The association between each comorbidity (hypertension (HTN), chronic kidney disease (CKD) or obesity) and PGC was evaluated through multivariate mixed effects logistic regression models. The measures of effect were odds ratios (OR) and their 95% confidence intervals (CI). We also evaluated the main associations stratified by gender, insurance, and early onset diabetes as well as statistical interaction between each comorbidity and ethnicity. Results From 969,531 people at baseline, 85% had at least one comorbidity; they were older and mostly female. In people living with DM and CKD, the odds of having a PGC were 78% (OR: 1.78, CI 95%: 1.55-2.05) higher than those without CKD. Same pattern was observed in obese for whom the odds were 52% (OR: 1.52, CI 95%: 1.31-1.75) higher than in non-obese. Non-significant association was found between HTN and PGC. We found statistical interaction between comorbidities and ethnicity (afro descendant) as well as effect modification by health insurance and early onset DM. Conclusions Prevalence of comorbidities was high in adults living with DM. Patients with concomitant CKD or obesity had significantly higher odds of having a PGC.

Published
2021
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28. Estimation of PQ distance dispersion for atrial fibrillation detection

Author

Sonia H. Contreras-Ortiz, Jader Giraldo-Guzmán, Francisco Castells, Marian Kotas, and Miguel Urina-Triana

Subjects
medicine.medical_specialty, medicine.medical_treatment, Spatio-temporal patterns, PQ dispersion Spatio–temporal, Health Informatics, Cardioversion, 030218 nuclear medicine & medical imaging, TECNOLOGIA ELECTRONICA, Electrocardiography, 03 medical and health sciences, QRS complex, 0302 clinical medicine, Rhythm, Heart Rate, Internal medicine, Heart rate, Dispersion (optics), medicine, Humans, 03.- Garantizar una vida saludable y promover el bienestar para todos y todas en todas las edades, Heart Atria, ECG processing, Lead (electronics), Spatio-temporal filtering, LEMB, business.industry, Cardiac arrhythmia, Atrial fibrillation, Spatio–temporal patterns, medicine.disease, PQ dispersion, Computer Science Applications, Spatio–temporal filtering, filtering Spatio–temporal patterns, Cardiology, business, 030217 neurology & neurosurgery, Software
Abstract

[EN] Background and objective: Atrial fibrillation (AF) is the most common cardiac arrhythmia in the world. It is associated with significantly increased morbidity and mortality. Diagnosis of the disease can be based on the analysis of the electrical atrial activity, on quantification of the heart rate irregularity or on a mixture of the both approaches. Since the amplitude of the atrial waves is small, their analysis can lead to false results. On the other hand, the heart rate based analysis usually leads to many unnecessary warnings. Therefore, our goal is to develop a new method for effective AF detection based on the analysis of the electrical atrial waves. Methods: The proposed method employs the fact that there is a lack of repeatable P waves preceding QRS complexes during AF. We apply the operation of spatio-temporal filtering (STF) to magnify and detect the prominent spatio-temporal patterns (STP) within the P waves in multi-channel ECG recordings. Later we measure their distances (PQ) to the succeeding QRS complexes, and we estimate dispersion of the obtained PQ series. For signals with normal sinus rhythm, this dispersion is usually very low, and contrary, for AF it is much raised. This allows for effective discrimination of this cardiologic disorder. Results: Tested on an ECG database consisting of AF cases, normal rhythm cases and cases with normal rhythm restored by the use of cardioversion, the method proposed allowed for AF detection with the accuracy of 98 . 75% on the basis of both 8-channel and 2-channel signals of 12 s length. When the signals length was decreased to 6 s, the accuracy varied in the range of 95% - 97 . 5% depending on the number of channels and the dispersion measure applied. Conclusions: Our approach allows for high accuracy of atrial fibrillation detection using the analysis of electrical atrial activity. The method can be applied to an early detection of the desease and can advantageously be used to decrease the number of false warnings in systems based on the analysis of the heart rate., The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article. This research is partially supported by statutory funds of the Depart-ment of Cybernetics, Nanotechnology and Data Processing, Sile-sian University of Technology, BK2021. Francisco Castells receives research funds from the National Research Program RETOS under grant PID2019-109547RB-I0 0 from the Ministry of Science, Spanish Government. Jader Giraldo received funds from Universidad Tecnologica de Bolivar, CartagenaColombia, (grantcode: C2018P022) . The work was performed using the infrastructure supported by POIG.02.03.0124099/13 grant: GeCONiI-Upper Silesian Center for Computational Science and Engineering.

Published
2021
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29. Prospective evaluation of lipid management following acute coronary syndrome in non-Western countries

Author

Miguel Urina-Triana, Mohammed Arafah, Ann Marie Navar, Eric D. Peterson, Valérie Corp dit Genti, Jaw Wen Chen, Apichard Sukonthasarn, S T Matskeplishvili, and Véronique Daclin

Subjects
Male, non‐Western countries, medicine.medical_specialty, Acute coronary syndrome, Statin, medicine.drug_class, Clinical Investigations, Disease, 030204 cardiovascular system & hematology, acute coronary syndrome, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Humans, Medicine, Non- Western countries, Low-density lipoprotein cholesterol, 030212 general & internal medicine, Myocardial infarction, Non-ST Elevated Myocardial Infarction, Lipid management, business.industry, Iipid management, low‐density lipoprotein cholesterol, Cholesterol, LDL, General Medicine, lipid management, medicine.disease, Lipids, Statin therapy, Non western, Treatment Outcome, statin therapy, Observational study, lipids (amino acids, peptides, and proteins), Hydroxymethylglutaryl-CoA Reductase Inhibitors, Cardiology and Cardiovascular Medicine, business
Abstract

Background Half the global burden of cardiovascular disease (CVD) is concentrated in the Asia‐Pacific (APAC) region. Hypothesis Suboptimal control of low‐density lipoprotein cholesterol (LDL‐C) may play a large role in the burden of CVD in APAC and non‐Western countries. Methods The Acute Coronary Syndrome Management (ACOSYM) registry is a multinational, multicenter, prospective observational registry designed to evaluate LDL‐C control in patients within 6 months after hospitalization following an acute coronary syndrome (ACS) event across nine countries. Results Overall, 1581 patients were enrolled, of whom 1567 patients met the eligibility criteria; 80.3% of the eligible patients were men, 46.1% had ST‐elevation myocardial infarction, and 39.5% had non‐ST‐elevation myocardial infarction. Most (1245; 79.5%) patients were discharged on a high‐intensity statin. During the follow‐up, only 992 (63.3%) patients had at least one LDL‐C measurement; of these, 52.9% had persistently elevated LDL‐C (>70 mg/dl). The patients not discharged on a high‐dose statin were more likely (OR 3.2; 95% CI 2.1–4.8) to have an LDL‐C above the 70 mg/dl LDL‐C target compared with those who were discharged on a high‐dose statin. Conclusion Our real‐world registry found that a third or more of post‐ACS patients did not have a repeat LDL‐C follow‐up measurement. In those with an LDL‐C follow‐up measurement, more than half (52.9%) were not achieving a

Published
2021
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30. Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Author

Teerlink, John R., Diaz, Rafael, Felker, G. Michael, McMurray, John J.V., Metra, Marco, Solomon, Scott D., Adams, Kirkwood F., Anand, Inder, Arias‐Mendoza, Alexandra, Biering‐Sørensen, Tor, Böhm, Michael, Bonderman, Diana, Cleland, John G.F., Corbalan, Ramon, Crespo‐Leiro, Maria G., Dahlström, Ulf, Echeverria Correa, Luis E., Fang, James C., Filippatos, Gerasimos, Fonseca, Cândida, Goncalvesova, Eva, Goudev, Assen R., Howlett, Jonathan G., Lanfear, David E., Lund, Mayanna, Macdonald, Peter, Mareev, Vyacheslav, Momomura, Shin‐ichi, O'Meara, Eileen, Parkhomenko, Alexander, Ponikowski, Piotr, Ramires, Felix J. A., Serpytis, Pranas, Sliwa, Karen, Spinar, Jindrich, Suter, Thomas M., Tomcsanyi, Janos, Vandekerckhove, Hans, Vinereanu, Dragos, Voors, Adriaan A., Yilmaz, Mehmet B., Zannad, Faiez, Sharpsten, Lucie, Legg, Jason C., Abbasi, Siddique A., Varin, Claire, Malik, Fady I., Kurtz, Christopher E., Besada, Diego Alejandro, Majul, Claudio Rodolfo, Bruno, Marco Raul Litvak, Sassone, Sonia, Avaca, Horacio Alberto, Rasmussen, Mariela, Aiub, Jorge Roberto, Hominal, Miguel Angel, Perna, Eduardo, Duran, Ruben Omar Garcia, Schiavi, Lilia, Marquez, Lilia Luz Lobo, Vilamajo, Oscar Alberto Gomez, Mackinnon, Ignacio, Fuente, Ricardo Alfonso Leon, Montana, Oscar Romano, Novaretto, Leonardo, Guerrero, Rodolfo Andres Ahuad, Brasca, Daniela Garcia, Prado, Aldo, Garrido, Marcelo Alejandro, Luquez, Hugo, Martinez, Diego Felipe, Nicolosi, Liliana, Parody, Maria Leonor, Zaidman, Cesar, Berra, Fernando Colombo, Ibañez, Julio, Zapata, Gerardo, Caccavo, Alberto, Colque, Roberto, Diez, Mirta, Poy, Carlos, Salomone, Oscar Alejandro, Vogel, Daniel, Bordonava, Anselmo Paulino, Fernandez, Alberto, French, John, Atherton, John, Hamilton, Andrew, Begg, Alistair, Abhayaratna, Walter, Judkins, Christopher, De Pasquale, Carmine, McKenzie, Scott, Amerena, John, Szto, Gregory, Kearney, Leighton, Zimmet, Hendrik, Sverdlov, Aaron, Beltrame, John, Korczyk, Dariusz, Sindone, Andrew, Moertl, Deddo, Huber, Kurt, Huelsmann, Martin, Ablasser, Klemens, Ebner, Christian, Siostrzonek, Peter, Drexel, Heinz, Poelzl, Gerhard, Dujardin, Karl, Dupont, Matthias, Buysschaert, Ian, Lancellotti, Patrizio, Droogne, Walter, Chouchane, Iman, Silveira, Fabio, Rassi, Salvador, Reis, Gilmar, Filho, Pedro Pimentel, Simoes, Marcus Vinicius, Braga, Joao Carlos, Giorgeto, Flavio Eduardo, Ferraz, Almir, Jaeger, Cristiano Pederneiras, Saraiva, Jose Francisco, Tognon, Alexandre, Cardoso, Juliano, Greco, Oswaldo, Paiva, Maria Sanali, Paolino, Bruno, Filho, Otavio Coelho, Maia, Lilia Nigro, Silva, Rodrigo, Canesin, Manoel, Rossi, Paulo Roberto Ferreira, Fortes, Jose Augusto Ribas, Cerci, Rodrigo Julio, Manenti, Euler Roberto Fernandes, Leaes, Paulo Ernesto, Silva Neto, Luis Beck, Souza, Weimar Kunz Barroso, Bacal, Fernando, Chaves, Renato, Ramires, Felix, Vidotti, Maria Helena, Barros e Silva, Pedro Gabriel Melo, Piegas, Leopoldo Soares, Todorov, Georgi, Tzekova, Maria, Goudev, Assen, Mincheva, Valentina, Vasilev, Ivaylo, Tisheva‐ Gospodinova, Snezhanka, Petrov, Ivo, Postadzhiyan, Arman, Velikov, Chavdar, Dimov, Bojidar, Constance, Christian, Phaneuf, Denis‐Carl, Mielniczuk, Lisa, Pandey, A Shekhar, Senaratne, Manohara, Zieroth, Shelley, Savard, Daniel, Stewart, Robert, Huynh, Thao, Giannetti, Nadia, Moe, Gordon, Bourgeois, Ronald, Ezekowitz, Justin, Hartleib, Michael, Sussex, Bruce, Babapulle, Mohan, Chehayeb, Raja, Gaudet, Daniel, McKelvie, Robert, Nguyen, Viviane, Roth, Sherryn, Gupta, Milan, Pesant, Yves, Rupka, Dennis, Bhargava, Rakesh, Costa‐Vitali, Atilio, Proulx, Guy, Vega, Mario, Potthoff, Sergio, Cid, Maria Cristina Schnettler, Sepulveda, Alex Mauricio Villablanca, Zanetti, Fernando Tomas Lanas, Gajardo, Victor Areli Saavedra, Kindel, Carlos Conejeros, Jofre, Christian Paolo Pincetti, Segarra, Jorge Leonardo Cobos, Venegas, Manuel Eduardo Rodriguez, Hidalgo, Mario Yanez, Jalaf, Margarita Gertrudis Vejar, Li, Weimin, Zhang, Jinguo, Fu, Xin, Zhang, Xuelian, Li, Dongye, Wang, Zhifang, Qu, Yanling, Zheng, Zhe, Tang, Huifang, Yang, Ping, Zhang, Yuhui, Zheng, Yang, Mi, Yafei, Huang, He, Bu, Peili, Chen, Guoqin, Chen, Jiyan, Han, Yajun, Li, Zhangquan, Ma, Shumei, Yang, Xuming, Yuan, Zuyi, Dong, Yugang, Li, Zhaoping, Mahemuti, Ailiman, Niu, Wentang, Yang, Zhenyu, Zhang, Yuqing, Sun, Yuemin, Wu, Weiheng, Liu, Feng, Yan, Jing, Li, Yinjun, Wang, Yi, Zhang, Shouyan, Zhou, Changyong, Cui, Hanbin, Li, Jianjun, Li, Tianfa, Han, Qinghua, Wei, Yu, Correa, Luis Eduardo Echeverria, Mendoza, Jose Luis Accini, Jattin, Fernando Manzur, Osorio, Wilder Castaño, Luengas, Carlos Alberto, Arroyo, Julian Alonso Coronel, Corredor, Miguel Alfredo Moncada, Giraldo, Clara Ines Saldarriaga, Lopez, Rodrigo Botero, Salazar, Dora Ines Molina, Triana, Miguel Urina, Lopez, Luis Horacio Atehortua, Rojas, Pastor Olaya, Pelaez, Sebastian Velez, Pareja, Monica Lopez, Bonfanti, Alberto Cadena, Polasek, Rostislav, Monhart, Zdenek, Sochor, Karel, Motovska, Zuzana, Belohlavek, Jan, Busak, Ladislav, Krupicka, Jiri, Tyl, Petr, Jerabek, Ondrej, Podpera, Ivo, Skrobakova, Janka, Peterka, Karel, Spacek, Rudolf, Cech, Vladimir, Kellnerova, Ivana, Nechvatal, Libor, Pozdisek, Zbynek, Houra, Marek, Kryza, Radim, Machova, Vilma, Cepelak, Michal, Stepek, David, Zeman, Kamil, Klimsa, Zdenek, Koleckar, Pavel, Schee, Alexandr, Spinarova, Lenka, Coufal, Zdenek, Jeppesen, Jorgen, Vraa, Soren, Wiggers, Henrik, Nyvad, Ole, Nielsen, Tonny, Kaiser‐Nielsen, Peter, Videbaek, Lars, Galinier, Michel, Lefebvre, Jean‐Marie, Tartiere, Jean‐Michel, De Geeter, Guillaume, Roubille, Francois, Ricci, Jean Etienne, Salvat, Muriel, Gueffet, Jean‐Pierre, Decoulx, Eric, Berdague, Philippe, Jondeau, Guillaume, Ovize, Michel, Groote, Pascal De, Donal, Erwan, Isnard, Richard, Sabatier, Rémi, Trochu, Jean Noel, Damy, Thibaud, Georges, Jean‐Louis, Rosamel, Yann, Picard, François, Aboyans, Victor, Laperche, Thierry, Mitrovic, Veselin, Taggeselle, Jens, Störk, Stefan, Ebelt, Henning, Genth‐Zotz, Sabine, Rassaf, Tienush, Duengen, Hans‐Dirk, Mittag, Marcus, Menck, Niels, Zeymer, Uwe, Haehling, Stephan, Boehm, Michael, Frankenstein, Lutz, Killat, Holger, Bourhaial, Hakima, Beug, Daniel, Horacek, Thomas, Pfister, Roman, Sandri, Marcus, Westenfeld, Ralf, Kadel, Christoph, Karvounis, Haralambos, Patsilinakos, Sotirios, Mantas, Ioannis, Karavidas, Apostolos, Giamouzis, Grigorios, Tsioufis, Konstantinos, Naka, Katerina, Tziakas, Dimitrios, Parissis, John, Styliadis, Ioannis, Barbetseas, Ioannis, Manolis, Athanasios, Kochiadakis, George, Herczeg, Bela, Nagy, Laszlo, Nyolczas, Noemi, Toth, Kalman, Merkely, Bela, Laszlo, Zoltan, Mark, Laszlo, Szakal, Imre, Papp, Andras, Bezzegh, Katalin, Lakatos, Ferenc, Hajko, Erik, Papp, Aniko, Forster, Tamas, Lupkovics, Geza, Mohacsi, Attila, Salamon, Csaba, Aradi, Daniel, Andreka, Peter, Szasz, Gyula, Zilahi, Zsolt, Kazinczy, Rita, Margonato, Alberto, Agostoni, Piergiuseppe, Fucili, Alessandro, Piovaccari, Giancarlo, Senni, Michele, Carluccio, Erberto, Bilato, Claudio, Frigerio, Maria, Indolfi, Ciro, Sinagra, Gianfranco, Brunetti, Natale Daniele, Perna, Gianpiero, Pini, Daniela, Volterrani, Maurizio, Leonardi, Sergio, Mortara, Andrea, Friz, Hernan Emilio Francisco Polo, Rossini, Roberta, Tocchetti, Carlo Gabriele, Vincenzi, Antonella, Cavallini, Claudio, Floresta, Agata Marina, Zaca, Valerio, Giudici, Vittorio, Villani, Giovanni Quinto, Higashino, Yorihiko, Oishi, Shogo, Wada, Atsuyuki, Fukuzawa, Shigeru, Onoue, Kenji, Koike, Akihiro, Koizumi, Tomomi, Masuda, Seigo, Mitsuo, Kazuhisa, Takahashi, Natsuki, Takenaka, Takashi, Tanabe, Jun, Watanabe, Naoki, Yoshida, Takeshi, Amano, Tetsuya, Ishikawa, Masahiro, Kida, Keisuke, Kubota, Toru, Nakamura, Kentaro, Sakamoto, Tomohiro, Shimomura, Mitsuhiro, Yuge, Masaru, Doi, Masayuki, Domae, Hiroshi, Ebato, Mio, Fujii, Kenshi, Fujiwara, Wakaya, Gohara, Seiichiro, Hata, Yoshiki, Kanda, Junji, Kitaoka, Hiroaki, Matsumoto, Takashi, Michishita, Ichiro, Miura, Shinichiro, Miyazaki, Tetsuro, Nakamura, Akihiro, Ogawa, Tomohiro, Okumura, Takahiro, Okumura, Yasuo, Sakai, Tetsuo, Sato, Yukihito, Shimizu, Wataru, Sugino, Hiroshi, Suzuki, Masahiro, Takagi, Atsutoshi, Takaishi, Hiroshi, Tanaka, Takahiro, Terasaki, Toshiro, Tsujimoto, Mitsuru, Ueda, Yasunori, Ujino, Keiji, Usui, Makoto, Yamamoto, Mitsutaka, Yoshikawa, Masaki, Ando, Kenji, Asakura, Masanori, Asano, Hiroshi, Fujii, Shigeru, Hara, Hisao, Inomata, Takayuki, Isshiki, Takaaki, Kadokami, Toshiaki, Kai, Hisashi, Kasai, Toshio, Kawamitsu, Katsunori, Kawasaki, Tomohiro, Koga, Tokushi, Komiyama, Nobuyuki, Maejima, Yasuhiro, Manita, Mamoru, Miyamoto, Nobuhide, Node, Koichi, Numaguchi, Kotaro, Sakata, Yasushi, Serikawa, Takeshi, Takama, Noriaki, Tatebe, Shunsuke, Ueno, Hideki, Hidaka, Takayuki, Hiroi, Shitoshi, Iseki, Harukazu, Ito, Hiroshi, Kajinami, Kouji, Kawakami, Hideo, Momiyama, Yukihiko, Mori, Masuki, Morita, Yukiko, Okishige, Kaoru, Sakagami, Satoru, Takeishi, Yasuchika, Terasawa, Akihiro, Utsu, Noriaki, Badariene, Jolita, Celutkiene, Jelena, Slapikas, Rimvydas, Jarasuniene, Dalia, Castillo, Armando Garcia, De los Rios Ibarra, Manuel Odin, Lopez, Gabriel Arturo Ramos, Llamas, Edmundo Alfredo Bayram, Esperon, Guillermo Antonio Llamas, Vazquez, Eduardo Salcido, Gonzalez, Ricardo Garcia, Leon, Jose Luis Arenas, Gonzalez, Salvador Leon, Mendoza, Maria Alexandra Arias, Rodriguez, Alicia Contreras, Machado, Gustavo Francisco Mendez, Salazar, Melchor Alpizar, Ruiz, Alberto Esteban Bazzoni, Flores, Ana Maria De Leon, Carrasco, Jose Alfredo Pagola, Araiza, Raul Reyes, Römer, Tjeerd, Remmen, Johannes, Van Eck, Jacob, Elvan, Arif, Smilde, Tom, Voors, Adriaan, Wal, Ruud, Schaap, Jeroen, Sluis, Aize, Linssen, Gerardus, Magro, Michael, Willems, Frank, Hal, John, Zwaan, Coenraad, Beelen, Driek, Boswijk, Dirk, Hermans, Walter, Van Kesteren, Henricus, Scott, Russell, Hart, Hamish, Lund, Marianne, Szczasny, Marcin, Blicharski, Tomasz, Kafara, Mariusz, Stankiewicz, Anna, Skonieczny, Grzegorz, Zabowka, Maciej, Kania, Grzegorz, Kopaczewski, Jerzy, Pawlowicz, Lidia, Spyra, Janusz, Wlodarczyk, Aleksander, Sciborski, Ryszard, Balsam, Pawel, Drozdz, Jaroslaw, Sobkowicz, Bozena, Konieczynska, Malgorzata, Lelonek, Malgorzata, Bednarkiewicz, Zbigniew, Trebacz, Jaroslaw, Jankowski, Piotr, Sidor, Mateusz, Berkowski, Piotr, Chmielak, Zbigniew, Lenartowska, Lucyna, Nessler, Jadwiga, Straburzynska‐Migaj, Ewa, Kalarus, Zbigniew, Kowalski, Robert, Kalecinska‐Krystkiewicz, Ewa, Gola, Zbigniew, Pijanowski, Zbigniew, Wozakowska‐Kaplon, Beata, Cymerman, Krzysztof, Rynkiewicz, Andrzej, Miekus, Pawel, Monteiro, Pedro, Sarmento, Pedro Morais, Almeida, Filipa, Duarte, Tatiana, Fonseca, Candida, Oliveira, Luis, Santos, Luis, Brito, Dulce, Stanciulescu, Gabriela, Spiridon, Marilena Renata, Militaru, Constantin, Podoleanu, Cristian Gheorghe, Zdrenghea, Dumitru, Popescu, Mircea Ioachim, Macarie, Cezar‐Eugen, Giuca, Alina, Mitu, Florin, Voicu, Olga‐Cristina, Dorobantu, Maria, Lighezan, Daniel, Stamate, Sorin, Bykov, Alexander, Kobalava, Zhanna, Zrazhevskiy, Konstantin, Semenova, Irina, Vishnevsky, Alexander, Shutemova, Elena, Tereschenko, Sergey, Shvarts, Yury, Barbarash, Olga, Lukyanov, Yury, Voevoda, Mikhail, Dovgolis, Svetlana, Dronov, Dmitry, Goloshchekin, Boris, Sitnikova, Maria, Ezhov, Marat, Tarasov, Nikolay, Kotelnikov, Mikhail, Kostenko, Viktor, Solovev, Oleg, Goncharov, Ivan, Myasnikov, Roman, Rafalskiy, Vladimir, Ryabov, Vyacheslav, Kosmacheva, Elena, Motylev, Igor, Nosov, Vladimir, Osipova, Irina, Salukhov, Vladimir, Belenkiy, Dmitriy, Bolshakova, Olga, Pimenov, Leonid, Shilkina, Nataliya, Kulibaba, Elena, Repin, Alexey, Timofeev, Alexander, Mitrokhin, Vladislav, Sherenkov, Alexander, Arbolishvili, Georgy, Antalik, Lubomir, Dzupina, Andrej, Fulop, Peter, Majercak, Ivan, Gonsorcik, Jozef, Vinanska, Daniela, Lenner, Egon, Lukacova, Jana, Margoczy, Roman, Smik, Rudolf, Stevlik, Jan, Uhliar, Rudolf, Burgess, Lesley, Badat, Aysha, Klug, Eric, Van Zyl, Louis, Abelson, Mark, Moodley, Rajendran, Tsabedze, Nqoba, Fourie, Nyda, Bonet, Luis Almenar, Prado, Jose Maria Arizon, Oliveira Soares, Manue Martinez‐Selles D, Villota, Julio Eduardo Nuñez, Leiro, Maria Generosa Crespo, Juanatey, Jose Ramon Gonzalez, Figal, Domingo Andres Pascual, Palomas, Juan Luis Bonilla, Perez, Sonia Mirabet, Jimenez, Juan Francisco Delgado, Padron, Antonio Lara, Diaz, Victor Alfonso Jimenez, Cubero, Javier Segovia, Paya, Vicente Eduardo Climent, Mayoral, Alejandro Recio, Fuente Galan, Luis, Doblas, Juan Jose Gomez, Freire, Ramon Bover, Peiro, Maria Teresa Blasco, Molina, Beatriz Diaz, Martinez, Laura Jordan, Vilchez, Francisco Gonzalez, Boman, Kurt, Karlstrom, Patric, Berglund, Stefan, Szabo, Barna, Peterson, Magnus, Wodlin, Peter, Lindholm, Carl‐Johan, Moccetti, Tiziano, Mueller, Christian, Suter, Thomas, Hullin, Roger, Meyer, Philippe, Noll, Georg, Yigit, Zerrin, Turgut, Okan Onur, Bekar, Lutfu, Sahin, Tayfun, Koldas, Zehra Lale, Celik, Ahmet, Cavusoglu, Yuksel, Demir, Mesut, Onrat, Ersel, Duzenli, Mehmet, Cosansu, Kahraman, Muderrisoglu, Ibrahim Haldun, Tuncer, Mustafa, Badak, Ozer, Nalbantgil, Sanem, Kirma, Cevat, Okuyan, Ertugrul, Guray, Umit, Prokhorov, Oleksandr, Karpenko, Oleksandr, Vakaliuk, Igor, Yagensky, Andriy, Kracz, Igor, Stanislavchuk, Mykola, Kulynych, Oleksii, Rishko, Mykola, Stets, Roman, Tseluyko, Vira, Mishchenko, Larysa, Rudenko, Leonid, Rudyk, Iurii, Alieksieieva, Liudmyla, Korzh, Oleksii, Mostovoy, Yuriy, Parkhomenko, Oleksandr, Rasputina, Lesya, Voronkov, Leonid, Lymar, Yurii, Vasilyeva, Larysa, Keeling, Philip, Barr, Craig, Wong, Kenneth, Price, Dallas, Skaria, Binoy, Clark, Andrew, Chandrasekaran, Badrinathan, Trevelyan, Jasper, Gordon, Brian, Donnelly, Patrick, Glover, Jason, Ryding, Alisdair, Weir, Robin, Lang, Chim, Roy, Debashis, Adhya, Shaumik, Clifford, Piers, Ludman, Andrew, Kalra, Paul, Lynch, Mary, Mahmood, Shahid, Al Mohammad, Abdallah, Asubiaro, Joshua, Elmahi, Einas, Muthumala, Amal, Taylor, Justin, Gupta, Dinesh, Nadar, Venkatesh, Henderson, David, Zolty, Ronald, Sauer, Andrew, Adams, Kirkwood, Chandra, Lokesh, Jaffrani, Naseem, Grewal, Gurinder, Mancini, Donna, McLean, Dalton, Vasallo, Javier, Gottlieb, Stephen, Joseph, Susan, Barua, Rajat, Gorodeski, Eiran, Mouhaffel, Asad, Chung, Eugene, Desai, Pratik, Portnay, Edward, Rama, Bhola, Shandling, Adrian, Stahl, Llyod, Heilman, Karl, Jacob, Binu, Londono, Juan, Almousalli, Omar, Ashcom, Thomas, Bauerlein, Eugene Joseph, Koo, Charles, McGrew, Frank, Rajagopalan, Navin, Robinson, Shawn, Schultz, David, Starling, Randall, Ambardekar, Amrut, Bhagwat, Ravi, Boehmer, John, Bouza, Manuel, Farris, Neil, Feitell, Scott, Ganji, Jagadeesh, Geltman, Edward, Javier, Julian, Morrow, John Andrew, Pianko, Leonard, Smart, Frank, Adler, Alexander, Brinkley, Douglas, Cardona, Jose, Coletti, Andrew, Harris, John, Hunter, Vernon, Krantz, Mori, Lang, Christopher, Lovell, Charles, Murray, David, Pillutla, Priya, Shah, Amit, Bogaev, Roberta, Dauber, Ira, Franchi, Francesco, Fremont, Richard, Hart, Terence, Hattler, Brack, Janik, Matthew, Khalife, Wissam, Malhotra, Sanjay, Mamdani, Shafiq, Nelson, William, Orgera, Marisa, Ortiz, Aurelio, Rahko, Peter, Rennyson, Stephen, Shin, Jooyoung, Tsao, Lana, Uretsky, Barry, Wahid, Faisal, Wilkett, Matt, Amanullah, Aman, Baker, Mathue, Berk, Martin, Boccalandro, Fernando, Cruz, Kimberly, Doyle, Timothy, Gianfagna, Robert, Jones, Alonzo, King, Anthony, Lepor, Norman, Martinez‐Castrillon, Melvin, Pham, Michael, Radin, Michael, Radojevic, Joseph, Ramanathan, Kodangudi, Schmalfuss, Carsten, Schnitzler, Robert, Shah, Keyur, Takata, Theodore, Bertolet, Barry, Bostick, Brian, Civitello, Andrew, Collins, John, Dib, Nabil, Fang, James, Gilmore, Richard, Gray, Wayne, Grazette, Luanda, Haddad, Tariq, Hearne, Steven, Janmohamed, Munir, Katz, Richard, Kazemi, Navid, Llerena, Sara, Lohr, Nicole, Marzouka, George, Mignone, John, Ooi, Henry, Paszczuk, Anna, Pickett, Christopher, Sampognaro, Gregory, Sawyer, Douglas, Shayani, Steven, Treasure, Charles, Vaz, Garth, Vijay, Nampalli, Williams, Celeste, Yeoman, Gary, Zhang, Lily, Aaronson, Keith, Abo‐Auda, Wael, Alharethi, Rami, Anderson, William, Ariani, Mehrdad, Banerji, Sourin, Baweja, Paramdeep, Carson, Peter, Eberly, Arthur, Elliott, James, Fernando, Ronald, Fisher, Daniel, Forman, Steven, Gabriel, George, Gogia, Harinder, Hametz, Craig, Houston, Brian, Ibrahim, Hassan, Jadbabaie, Farid, Kassiotis, Christos, Krishnamoorthy, Arun, Kwan, Michael, Lupovitch, Steven, Macias, Leonardo, Malik, Adnan, Martinez, Luis, Miyamoto, Michael, Mody, Freny, Patel, Devesh, Peart, Brenda, Pisani, Barbara, Ramos, Mark, Rivero, Mariel, Shah, Anil, Sharma, Mukesh, Sichrovsky, Tina, Simon, Marc, Singh, Deovrat, Tallet, Julio, Vaccari, Christopher, Villoch, Mario, Wheeler, Matthew, Yousuf, Kabir, Abadier, Rafik, Abdullah, Shuaib, Arora, Raveen, Aslam, Shamaila, Buynak, Robert, Chang, David, Contreras, Johanna, Halpern, Stephen, Handel, Franklin, Heitner, John, Herzog, William, Jackson, Bruce, Kao, John, Kondo, Nicholas, Koren, Michael, LeWinter, Martin, Martindale, Jeffrey, Martinez‐Arraras, Joaquin, Olsen, Stephanie, Piatek, Marek, Ranadive, Nandkishore, Randall, William, Rao, Sunder, Rawitscher, David, Rider, James, Sokos, George, Strader, J Russell, Sulemanjee, Nasir, Tahirkheli, Naeem, Trichon, Benjamin, Vanhecke, Thomas, Whellan, David, Abuannadi, Mohammad, Aggarwala, Gaurav, Ahmad, Saad, Artis, Andre, Cheirif, Jorge, Cotarlan, Vladimir, Cox, Jeremy, Eaton, Charles, Florea, Viorel, Frank, Theodore, Friedman, Keith, Ganeshram, Vedampattu, Gass, Alan, Gemignani, Anthony, Hasni, Syed, Hedgepeth, Chester, Itchhaporia, Dipti, Kaluski, Edo, Karim, Amin, Kono, Alan, Lader, Ellis, Lakshminarayanan, Batlagundu, Lewis, Neil, Malhotra, Vinay, Mayer, Nolan, Mohapatra, Robert, Nair, Nandini, O'Brien, Terrence, Pauwaa, Sunil, Rowan, Christopher, Saxena, Sanjeev, Seto, Arnold, Shah, Nishant, Singh, Pradeep, Skopicki, Hal, Stoddard, Marcus, and Sweitzer, Nancy

Subjects
R1
Abstract

Aims:\ud The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials.\ud \ud Methods and Results:\ud Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure

Published
2020

31. Impacto del aislamiento preventivo obligatorio en la actividad física diaria y en el peso de los niños en Colombia durante la pandemia por SARS-cov-2

Author

Juan Carlos Santacruz, Miguel Urina Triana, and Harold Arévalo

Subjects
2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), media_common.quotation_subject, Physical activity, physical activity, actividad física, Article, 03 medical and health sciences, 0302 clinical medicine, children, Diseases of the circulatory (Cardiovascular) system, overweight, media_common, sobrepeso, 030229 sport sciences, Art, covid-19, alimentación, RC666-701, aislamiento, Cardiology and Cardiovascular Medicine, Humanities, isolation, 030217 neurology & neurosurgery, niños, feeding
Abstract

Resumen: Introducción: En Colombia, desde el 24 de marzo hasta el 31 de agosto de 2020, los niños y adolescentes estuvieron 162 días en total aislamiento preventivo obligatorio por la pandemia por COVID-19. Objetivo: Conocer y evaluar el comportamiento de niños y adolescente durante el período de confinamiento por Covid-19, para establecer las consecuencias sobre la actividad física y el aumento peso. Métodos: Se elaboró una encuesta virtual abierta realizada en la plataforma de encuestas de Google, dirigida a los padres, la cual estuvo conformada por 5 preguntas: 1. ¿Qué edad tiene su hijo? 2. ¿Cuántos minutos por día de actividad física realiza en casa? 3. ¿Cuántos minutos de pantallas (TV, computador, celular, videojuegos, etc.) ve su hijo al día? 4 ¿Cuántas horas duerme su hijo en la noche? 5. ¿Se ha elevado el peso corporal de su hijo(a)? ¿Cuánto? La encuesta se distribuyó en las bases de datos de la Asociación de Medicina del Deporte y de la Fundación Colombiana del Corazón a través de redes sociales, como WhatsApp, y correos electrónicos. Resultados: Se realizaron 1.139 encuestas virtuales. Se encontró que durante el período de aislamiento obligatorio el 75,2% de los niños no realizó los minutos recomendados de actividad física por la Organización Mundial de la salud (OMS), que el 82,8% superó el tiempo de 60 minutos frente a dispositivos electrónicos y que el 44% aumentó de peso. Conclusiones: En los períodos de confinamiento es importante diseñar estrategias y procesos educativos que promuevan en los niños estilos de vida que puedan conservar a futuro, cuando sean adultos. Abstract: Introduction: In Colombia from March 24 to August 31, 2020, children and adolescents spent 162 days in total mandatory preventive isolation due to the Covid-19 pandemic. Objective: To know and evaluate their behavior of children and adolescents during this period of confinement in order to establish the consequences on the physical activity and weight gain. Methods: An open virtual survey was developed on the Google survey platform, addressed to parents with 5 questions: 1. How old is your child: 2. How many minutes of physical activity at home do you do? 3. How many minutes of screens (TV, computer, cell phone, video games, etc.) her or she watch per day? 4. How many hours does he or she sleep at night? 5. Has your child's body weight increased? How much? This survey was distributed in the databases of the Association of Sports Medicine and the Colombian Heart Foundation through social networks such as WhatsApp and emails. Results: 1,139 virtual surveys were conducted. It was found that during the mandatory isolation period: 75.2% of the children did not perform the minutes of physical activity recommended by the World Health Organization (WHO), that 82.8% exceeded the time of 60 minutes versus to electronic devices and that 44% weight gained. Conclusions: In periods of confinement, it is important to design educational strategies and processes that promote healthy lifestyles in children that can be preserved in the future in adults.

Published
2020

32. May Measurement Month 2018. An analysis of blood pressure screening results from Colombia

Author

Jose Lopez-Lopez, Johanna Otero, Patricio Lopez-Jaramillo, María Eugenia Casanova, Thomas Beaney, Miguel Urina-Triana, Daniela Ney-Salazar, Anca Chis Ster, Henry García, Neil R Poulter, Juliana Alvernia, Edgar Arcos, Gustavo Aroca, Jose L. Accini, Gregorio Sanchez-Vallejo, and Masira

Subjects
medicine.medical_specialty, Disease, 030204 cardiovascular system & hematology, Asymptomatic, Screening programme, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Control, Medicine, AcademicSubjects/MED00200, 030212 general & internal medicine, Risk factor, 1102 Cardiorespiratory Medicine and Haematology, Cause of death, business.industry, Public health, Articles, Treatment, Blood pressure, Cardiovascular System & Hematology, Emergency medicine, Hypertension, Screening, medicine.symptom, Cardiology and Cardiovascular Medicine, business
Abstract

Digital, High blood pressure (BP) is the leading global preventable cause of death and the most common risk factor for cardiovascular disease (CVD). However, due to its asymptomatic nature, the lack of awareness of this condition causes underdiagnosis and low rates of adherence to pharmacological treatment. Looking for practical approaches to increase awareness worldwide, the International Society of Hypertension (ISH) implemented the 2nd May Measurement Month campaign in 2018 (MMM18). In order to contribute to this initiative, Colombia participated as one of the 89 countries involved in this hypertension screening programme. Blood pressure was measured in subjects from 11 departments in Colombia. Under the leadership of the Fundación Oftalmológica de Santander (FOSCAL), 400 volunteers across the country collected the data following the MMM protocol. Measurements from 35 548 participants with a mean age of 41.9 years were obtained. In total, 9475 (26.7%) of the total population studied had hypertension. Of those with hypertension, 69.9% of these subjects were aware of their condition, 65.0% were on antihypertensive medication, and 43.1% had controlled BP. Of those on medication, 66.3% had controlled BP. Hypertension screening, awareness, treatment, and control should be a priority in public health objectives due to its elevated burden of disease and direct association with increased CVD. The MMM campaign provided a positive impact in the diagnosis of hypertension across Colombia. Although efforts are being made to expand treatment capability and adherence, still more are needed to insure a broader coverage of antihypertensive medication in Colombia., Ciencias Médicas y de la Salud

Published
2020

33. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes

Author

Miguel Urina, Jonathan Barratt, Ru San Tan, Carlos Eduardo Poli de Figueiredo, Bertrand Cariou, Walter Abhayaratna, Sofia Malyutina, Andreas Kistler, Liffert Vogt, Ciprian Constantin, Michal Nowicki, Jingmei Li, Gunnar Gislason, Jonas Spaak, Idalina Beirão, Markus Van der Giet, Ilona Kurnatowska, Peter Rossing, Mario Cozzolino, Maria Isabel Troya, Pathology/molecular and cellular medicine, Diabetes Pathology & Therapy, and Diabetes Clinic

Subjects
Male, amyotrophic lateral sclerosis, Endocrinology, Diabetes and Metabolism, Terapéutica, Enfermedad cardiovascular, Type 2 diabetes, 030204 cardiovascular system & hematology, urologic and male genital diseases, Tratamiento médico, 0302 clinical medicine, Mineralocorticoid receptor, Malalties cròniques, Diabetic Nephropathies, 030212 general & internal medicine, Metabolismo, Diabetis, Fallo renal crónico, Diabetes, General Medicine, Phenylbutyrates, female genital diseases and pregnancy complications, Treatment Outcome, Diabetes mellitus tipo 2, Creatinine, Female, Glomerular filtration rate, medicine.symptom, medicine.medical_specialty, Finerenone, Urology, Renal function, Phenylbutyrate, Assaigs clínics de medicaments, 03 medical and health sciences, Double-Blind Method, Diabetes mellitus, Chronic renal failure, medicine, Albuminuria, Humans, Naphthyridines, Renal Insufficiency, Chronic, Aged, urogenital system, business.industry, Drug testing, medicine.disease, Diabetes Mellitus, Type 2, Chronic diseases, Insuficiència renal crònica, Hyperkalemia, business, Kidney disease
Abstract

Background: Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, reduced albuminuria in short-term trials involving patients with chronic kidney disease (CKD) and type 2 diabetes. However, its long-term effects on kidney and cardiovascular outcomes are unknown. Methods: In this double-blind trial, we randomly assigned 5734 patients with CKD and type 2 diabetes in a 1:1 ratio to receive finerenone or placebo. Eligible patients had a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300, an estimated glomerular filtration rate (eGFR) of 25 to less than 60 ml per minute per 1.73 m2 of body-surface area, and diabetic retinopathy, or they had a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of 25 to less than 75 ml per minute per 1.73 m2. All the patients were treated with renin-angiotensin system blockade that had been adjusted before randomization to the maximum dose on the manufacturer's label that did not cause unacceptable side effects. The primary composite outcome, assessed in a time-to-event analysis, was kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes. The key secondary composite outcome, also assessed in a time-to-event analysis, was death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Results: During a median follow-up of 2.6 years, a primary outcome event occurred in 504 of 2833 patients (17.8%) in the finerenone group and 600 of 2841 patients (21.1%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P = 0.001). A key secondary outcome event occurred in 367 patients (13.0%) and 420 patients (14.8%) in the respective groups (hazard ratio, 0.86; 95% CI, 0.75 to 0.99; P = 0.03). Overall, the frequency of adverse events was similar in the two groups. The incidence of hyperkalemia-related discontinuation of the trial regimen was higher with finerenone than with placebo (2.3% and 0.9%, respectively). Conclusions: In patients with CKD and type 2 diabetes, treatment with finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo. Bayer; FIDELIO-DKD ClinicalTrials.gov number, NCT02540993. 91.253 JCR (2020) Q1, 1/167 Medicine, General & Internal 19.889 SJR (2020) Q1, 3/2447 Medicine (miscellaneous) No data IDR 2020 UEM

Published
2020
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34. Las dislipidemias y su tratamiento en centros de altacomplejidad en Colombia

Author

Gustavo Parra, Adalberto Quintero, Mónica Jaramillo, Dora I. Molina, Hernando Vargas-Uricoechea, Hernán Yupanqui Lozano, Edwin Etayo, Alberto Cadena, Boris Eduardo Vesga-Angarita, Juan M. Cárdenas, Alonso Merchán, Juan Manuel Toro, Juan M. Arteaga, Álvaro J. Ruiz, Alvaro Mauricio Quintero, Rodrigo Botero, Mónica Betancur-Valencia, Etna Valenzuela-Plata, Alejandro Román-González, Miguel Urina-Triana, and Daniel Isaza

Subjects
Dyslipidaemia, Enfermedad cardiovascular, Statins, 030204 cardiovascular system & hematology, Atherosclerosis, Cardiovascular disease, 03 medical and health sciences, 0302 clinical medicine, Dislipidemia, Pharmacology (medical), 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, Familial hypercholesterolaemia, Estatinas, Aterosclerosis, Hipercolesterolemia familiar
Abstract

Antecedentes y objetivo: Los datos sobre la distribución de las dislipidemias en Colombia sonlimitados. El objetivo primario de este estudio fue describir la frecuencia de las dislipidemias; los objetivos secundarios fueron: la frecuencia de comorbilidades cardiovasculares, el uso de estatinas y otros hipolipemiantes, la frecuencia de intolerancia a estatinas, el porcentaje de pacientes en metas de c-LDL, y estimar la distribución del riesgo cardiovascular (RCV).Materiales y métodos: Estudio transversal con recolección de datos retrospectiva que incluyóa 461 pacientes con diagnóstico de dislipidemia tratados en 17 centros cardiovasculares de altacomplejidad en las 6 principales áreas geográficas y económicas de Colombia.Resultados: La media (DE) de edad de los pacientes incluidos fue de 66,4 (±12,3) a˜nos. El 53,4%(246) eran mujeres. Las dislipidemias se distribuyeron así: dislipidemia mixta (51,4%), hiperco-lesterolemia (41,0%), hipertrigliceridemia (5,4%), hipercolesterolemia familiar (3,3%) y c-HDLbajo (0,7%). El medicamento más prescrito fue atorvastatina (75,7%), seguido de rosuvastatina(24,9%). El 55% del total de pacientes y el 28,6% de aquellos con enfermedad coronaria noestaban en metas de c-LDL a pesar del tratamiento. La frecuencia de intolerancia a estatinas fue del 2,6%.Conclusiones: La dislipidemia mixta y la hipercolesterolemia son las dislipidemias más frecuentes. Un porcentaje considerable de pacientes en tratamiento, incluidos aquellos con enfermedad coronaria, no lograron sus objetivos de c-LDL. Este inadecuado control lipídicoinfluye en el RCV y requiere un cambio en las estrategias terapéuticas, intensificando el trata-miento con estatinas o adicionando nuevos fármacos en los pacientes con mayor RCV.© 2020 Sociedad Española de Arteriosclerosis. Publicado por Elsevier España, S.L.U. Todos los derechos reservados. Background and objective: Data is scarce on the distribution of different types of dyslipidae-mia in Colombia. The primary objective was to describe the frequency of dyslipidaemias. Thesecondary objectives were: frequency of cardiovascular comorbidity, statins and other lipid-lowering drugs use, frequency of statins intolerance, percentage of patients achieving c-LDLgoals, and distribution of cardiovascular risk (CVR).Materials and methods: Cross-sectional study with retrospective data collection from 461patients diagnosed with dyslipidaemia and treated in 17 highly specialised centres distributedinto six geographic and economic regions of Colombia.Results: Mean (SD) age was 66.4 (±12.3) years and 53.4% (246) were women. Dyslipidaemiaswere distributed as follows in order of frequency: mixed dyslipidaemia (51.4%), hypercholes-terolaemia (41.0%), hypertriglyceridaemia (5.4%), familial hypercholesterolaemia (3.3%), andlow c-HDL (0.7%). The most prescribed drugs were atorvastatin (75.7%) followed by rosuvas-tatin (24.9%). As for lipid control, 55% of all patients, and 28.6% of those with coronary heartdisease, did not achieve their personal c-LDL goal despite treatment. The frequency of statinintolerance was 2.6% in this study.Conclusions: Mixed dyslipidaemia and hypercholesterolaemia are the most frequent dyslipidae-mias in Colombia. A notable percentage of patients under treatment with lipid-lowering drugs,including those with coronary heart disease, did not achieve specific c-LDL goals. This poor lipidcontrol may worsen patient’s CVR, so that therapeutic strategies need to be changed, eitherwith statin intensification or addition of new drugs in patients with higher CVR.© 2020 Sociedad Espa˜nola de Arteriosclerosis. Published by Elsevier Espa˜na, S.L.U. All rightsreserved.

Published
2020

35. Machine Learning approach applied to Human Activity Recognition – An application to the VanKasteren dataset

Author

Paola, Ariza-Colpas, primary, Alvaro Agustín, Oñate-Bowen, additional, Eydy del Carmen, Suarez-Brieva, additional, Ana, Oviedo-Carrascal, additional, Miguel, Urina Triana, additional, Marlon, Piñeres-Melo, additional, Shariq Aziz, Butt, additional, Collazos Morales, Carlos Andrés, additional, and Ramón Enrique, Ramayo González, additional

Published
2021
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36. Predictive model for the identification of activities of daily living (ADL) in indoor environments using classification techniques based on Machine Learning

Author

Johanna, García-Restrepo, primary, Paola Patricia, Ariza-Colpas, additional, Alvaro Agustín, Oñate-Bowen, additional, Eydy del Carmen, Suarez-Brieva, additional, Miguel, Urina-Triana, additional, Emiro, De-la-Hoz-Franco, additional, Jorge Luis, Díaz-Martínez, additional, Shariq Aziz, Butt, additional, and Diego, Molina_Estren, additional

Published
2021
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38. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease

Author

Stephane Ederhy, Gilmar Reis, Andrzej Rynkiewicz, Keith Fox, Luca Padua, Helene ABERGEL, Andrew Murphy, Andrzej Szuba, YAN CARLOS DUARTE VERA, Pawel Maga, Scott Berkowitz, Roxana Buzas, Alexey Repin, Gregory Ducrocq, Olga Barbarash, Anton Sadomov, Grzegorz Gajos, Miguel Urina, David McEneaney, Richard Tytus, Dmitriy Panov, Angelika Chachaj, Weimar Kunz Sebba Barroso Souza, Akihiko Takahashi, Salim Yusuf, Mpiko Ntsekhe, Elena Gromova, David Halon, Richard Cheng, Marcello Galvani, Rohan Poulter, JUAN PABLO YEPEZ ALVARAN, Sara Doimo, Kim Houlind, Marcelo Arruda Nakazone, Avinainder Singh, Fabrice Martens, Aldo Pietro Maggioni, Fredrik Folke, Miroslav Brtko, Peter Verhamme, Laszlo Koranyi, Bart Meuris, ALVARO AVEZUM, Boris Vesga, Cyrille Boulogne, Peter Sinnaeve, Zhanna Sizova, Marianna Janion, Crina Julieta Sinescu, Laurent BERTOLETTI, Susanne Brenner, Jaroslav Hlubocký, ELENA BOBESCU, Michelle Canavan, Kamil Bury, Elena Nalesnik, Robert Mikulik, Yaroslav Malynovsky, Liudmyla Parkhomenko, Andrea Barbieri, Philippe Gabriel STEG, Kelley Branch, Olga Shestakovska, Jan Fedacko, Khairul Shafiq Ibrahim, Nicolae-Dan Tesloianu, Daniel Pella, Paul Fedak, Pavel Kaplan, Shirley Jansen, Martin O'Donnell, Marlena Broncel, Fernando Lanas, Stefan Störk, Natalia Garganeeva, Heyman Luckraz, CARLOS AUGUSTO CELEMIN FLOREZ, Larysa Mishchenko, Amos Katz, Jaroslava Paulasova Schwabova, Patricio Lopez-Jaramillo, Gustavo Aroca, Monika Możdżan, Zoltan Varallyay, María José Paucar, Tim Ramsay, Fernando Botto, Muhammad Imran Abdul Hafidz, Juan Esteban Gómez-Mesa, Kaijian Hou, Miroslav Spacek, Tomasz Guzik, Diego Rizzotti, Jackie Bosch, Shrikant Bangdiwala, Robert Welsh, Vojtěch Novotný, Andriy Bazylevych, Niall Mahon, Serhii Serik, Irina PARVU, Daniel Turek, Laurent Feldman, Dmitry Zateyshchikov, Mykola Bychkov, Yury Vasyuk, Camilo Felix, James Cotton, DHAYRA KAREM BARRETO, Sergey Kozhukhov, Sergio Zimmermann, Whady Hueb, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7), Biomedical Engineering and Physics, Other departments, ACS - Amsterdam Cardiovascular Sciences, Pulmonology, Graduate School, Radiology and Nuclear Medicine, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism

Subjects
Male, 030204 cardiovascular system & hematology, law.invention, 0302 clinical medicine, Rivaroxaban, Randomized controlled trial, law, Hemorrhage/chemically induced, Secondary Prevention, Atherosclerosis/complications, 030212 general & internal medicine, Myocardial infarction, Factor Xa Inhibitors/adverse effects, Rivaroxaban/adverse effects, Stroke, risk, Aspirin, oral rivaroxaban, Research Support, Non-U.S. Gov't, Hazard ratio, General Medicine, Middle Aged, trial, Clopidogrel, 3. Good health, Multicenter Study, Cardiovascular Diseases, Randomized Controlled Trial, Platelet aggregation inhibitor, Drug Therapy, Combination, Female, secondary prevention, medicine.drug, Platelet Aggregation Inhibitors/adverse effects, medicine.medical_specialty, venous thromboembolism, Hemorrhage, Aspirin/adverse effects, 03 medical and health sciences, Secondary Prevention/methods, Double-Blind Method, Internal medicine, Journal Article, medicine, Humans, Aged, clopidogrel, business.industry, ta3121, Atherosclerosis, atherothrombotic events, medicine.disease, Surgery, Cardiovascular Diseases/drug therapy, business, Platelet Aggregation Inhibitors, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Factor Xa Inhibitors
Abstract

BACKGROUND: We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention.METHODS: In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months.RESULTS: The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; PCONCLUSIONS: Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events. (Funded by Bayer; COMPASS ClinicalTrials.gov number, NCT01776424 .).

Published
2017
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39. Guidelines on the management of arterial hypertension and related comorbidities in Latin America

Author

Patricio Lopez-Jaramillo, Heitor Moreno, Andréa Araujo Brandão, Armando da Rocha Nogueira, Carlos I Ponte-Negretti, David de Pádua Brasil, Livia Machado, José Fernando Vilela-Martin, Ramiro A. Sánchez, Alexandre Alessi, Miguel Urina-Triana, Antonio Coca, Rosa Simsolo, José Z. Parra-Carrillo, Alberto Morales-Salinas, Luis García-Ortiz, Angel Gonzalez Caamano, Jose Ortellado, Deborah Malta, Alberto Zanchetti, Luiz Aparecido Bortolotto, Agustin J. Ramirez, Rafael Hernández Hernández, Joffre Lara, Margarita Díaz, Weimar Kunz Sebba Barroso, Guillermo Burlando, Jesus Lopez, Carlos Alberto Machado, Eduardo Barbos, Gabriel Dario Waissman, Alfonso Bryce Moncloa, Marcio Kalil, Helena Schmid, Mario Fritsch, Fernando Lanas, Osni Moreira Filho, Thiago Veiga Jardim, Segundo Senclen Santisteban, Jose Augusto Barreto Filho, Jose Luis Accini Mendoza, Rui Manuel dos Santos Póvoa, Liliana Voto, JM Ribeiro, Sergio Baiocchi, Gregorio Sánchez, Eduardo Barbosa, Dora I. Molina, Marco Antonio Mota Gomes, Luis Alcocer, Décio Mion, Oswaldo Passarelli, Marcus Vinícius Bolívar Malachias, Raul Villar Moya, F. Wyss, Celso Amodeo, Fernando Nobre, Claudio Gonzalez, Roberto Dischinger Miranda, Leonardo Cobos, Wille Oigman, Paulo César Brandão Veiga Jardim, Audes D. M. Feitosa, and Daniel Piskorz

Subjects
Pediatrics, Latin Americans, blood-pressure control, Physiology, cardiovascular-disease, Blood Pressure, Comorbidity, 030204 cardiovascular system & hematology, law.invention, 0302 clinical medicine, Randomized controlled trial, Pregnancy, low-income countries, law, Medicine, purl.org/pe-repo/ocde/ford#3.02.04 [https], guidelines, masked hypertension, 030212 general & internal medicine, risk-factors, Metabolic Syndrome, Incidence (epidemiology), Arteries, Stroke, Hypertension, Practice Guidelines as Topic, outcome, purl.org/pe-repo/ocde/ford#3.02.27 [https], Female, Kidney Diseases, Cardiology and Cardiovascular Medicine, Risk, Blood pressure control, medicine.medical_specialty, hypertension, Pregnancy Complications, Cardiovascular, comorbidities, metabolic syndrome, european-society, Diabetes Complications, Peripheral Arterial Disease, 03 medical and health sciences, Internal Medicine, Humans, Obesity, Life Style, Antihypertensive Agents, Dyslipidemias, business.industry, Type 2 Diabetes Mellitus, medicine.disease, Masked Hypertension, Latin America, randomized-trials, Chronic Disease, incidence, Cardiovascular System & Cardiology, type-2 diabetes-mellitus, Metabolic syndrome, business
Abstract

Hypertension is the most frequence chronic noncomunicable disease (NCD) occurring in early propoductive stage of life and the main risk factor for attributable mortality, years of life lost and years lost for incapacity adjusted by age and disability-adjusted life year. The WHO estimated that hypertension prevalence is around 25% of the world population, predicting that it will increase by 60% by 2025...

Published
2017
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40. Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial

Author

Ruilope, Luis M, Agarwal, Rajiv, Anker, Stefan D, Bakris, George L, Filippatos, Gerasimos, Nowack, Christina, Kolkhof, Peter, Joseph, Amer, Mentenich, Nicole, Pitt, Bertram, Diego, Besada, Alfredo, Wassermann, Julio, Bittar, Alicia, Elbert, Augusto, Vallejos, Gloria, Viñes, Hugo, Sanabria, Federico Pérez Manghi, Alberto, Liberman, Inés, Bartolacci, Diego, Aizenberg, Mariano, Chahin, Laura, Maffei, Elizabeth, Gelersztein, Bernhard, Ludvik, Hans-Robert, Schönherr, Heinz, Drexel, Wolfgang, Preiß, Ursula, Hanusch, Peter, Neudorfer, Friedrich, Prischl, Bernhard, Paulweber, Christoph, Ebenbichler, Rudolf, Prager, Harald, Sourij, Gerit-Holger, Schernthaner, Martin, Clodi, Evelyn, Fliesser-Görzer, Elif, Ekinci, Richard, Macisaac, David, Packham, Hugo, Stephenson, Michael, Suranyi, Gary, Wittert, Katie-Jane, Wynne, Alexia, Pape, Duncan, Topliss, Peter, Colman, Craig, Nelson, James, Vandeleur, David, Colquhoun, Simon, Roger, Peak Mann Mah, Walter, Abhayaratna, Luc VAN Gaal, Pieter, Gillard, Jean-Michel, Hougardy, Marijn, Speeckaert, Koen, Stas, Wendy, Engelen, Francis, Duyck, André, Scheen, Hilde, Vanbelleghem, Peter, Doubel, Svetla, Vasileva, Rosen, Rashkov, Boyan, Nonchev, Theodora, Temelkova-Kurktschieva, Mariana, Yoncheva-Mihaylova, Rangel, Rangelov, Neli, Klyuchkova, Pavel, Stanchev, Zhivko, Tagarev, Radostina, Boshnyashka, Petya, Manova, Zhulieta, Prakova, Mariya, Lucheva, Valentina, Gushterova, Ghassan, Farah, Dimitar, Georgiev, Mariyana, Pichmanova, Dotska, Minkova, Bilyana, Stoyanovska-Elencheva, Maria Eugenia Canziani, Miguel, Hissa, Irene, Noronha, Joao Eduardo Salles, Daniela, Antunes, Freddy, Eliaschewitz, Carlos Eduardo Figueiredo, Rogerio de Paula, Luis, Canani, Maurilo Leite Jr, Bruno, Paolino, Rosangela, Rea, Sergio, Vencio, Claudia, Brito, Raphael, Paschoalin, Roberto Pecoits Filho, Eduardo, Vasconcellos, Nathalia, Paschoalin, Adriana, Forti, Roberto, Botelho, Miguel, Riella, Dalton, Precoma, Maria, Cerqueira, Lilia, Maia, Evandro, Portes, Marcio, Pereira, Joanne, Liutkus, Dennis, O Keefe, Richard, Tytus, Brian, Carlson, James, Conway, Michael, Walsh, Igor, Wilderman, Andrew, Steele, Sheldon, Tobe, Louise, Vitou, Karthik, Tennankore, Valdemar, Martinho, Philip, Mcfarlane, Daniel, Shu, Serge, Cournoyer, Richard, Dumas, Giuseppe, Mazza, Guy, Tellier, George, Tsoukas, Stanley, Weisnagel, Jean-Francois, Yale, Sameh, Fikry, Randolph, Hart, Pavel, Hamet, Francois, Madore, Paul, Barre, Daniel, Schwartz, Allan, Kelly, Ivor, Teitelbaum, Sean, Peterson, Sam, Henein, Richard, Goluch, Gregoire, Wuerzner, Markus, Laimer, Stefan, Bilz, Marc, Donath, Gottfried, Rudofsky, Christopher, Strey, Antoinette, Pechère-Bertschi, Paola, Varleta, Fernando, González, Marcelo, Medina, Carmen, Romero, Victor, Saavedra, Juan Carlos Prieto, Eliana, Reyes, Juan Carlos Palma, Jorge, Cobos, Zhihong, Liu, Dalong, Zhu, Nan, Chen, Fang, Liu, Wang, Li, Qing, Su, Bingyin, Shi, Aiping, Yin, Hao, Wang, Yan, Li, Jianying, Niu, Chaoqing, Wu, Xinjun, Wang, Ying, Zhang, Peng, Ai, Jianhua, Ma, Yuxiu, Li, Hongguang, Zheng, Minxiang, Lei, Zhaohui, Mo, Nanwei, Tong, Jinluo, Cheng, Youping, Dong, Xudong, Xu, Qinkai, Chen, Tianjun, Guan, Gang, Long, Changying, Xing, Ling, Li, Yinghong, Liu, Hao, Zhang, Ling, Zhong, Zhonghe, Li, Longyi, Zeng, Jiali, Wei, Hanqing, Cai, Tianfeng, Wu, Weiping, Lu, Ning, Xu, Yibing, Lu, Dejun, Chen, Ruifang, Bu, Jiansong, Shen, Junwu, Dong, Zhiquan, Zhao, Fei, Xiong, Fangfang, Jiang, Jinkui, Yang, Jian, Kuang, Guoyuan, Lu, Lihua, Wang, Yanlin, Zhang, Shuifu, Tang, Weiying, Guo, Jian, Liu, Sheng, Jiang, Fang, Yi, Yuming, Du, Zhuxing, Sun, Yuantao, Liu, Liyong, Zhong, Dongmei, Li, Hongmei, Li, Chuanming, Hao, Feixia, Shen, Jianqin, Wang, Jingmei, Li, Dora, Molina, Carlos, Cure, Jaime, Ibarra, Gustavo, Aroca, Hernán, Yupanqui, Eric, Hernández, Mónica, López, Gregorio, Sánchez, Germán, Barreto, Edgar, Arcos, Miguel, Urina, William, Kattah, Carlos, Durán, Clara, Arango, Julian, Coronel, Guillermo, Blanco, Mónica, Terront, Gustavo, Guzmán, Luis, García, Carlos, Jaramillo, Manuel, Liévano, Diego, Benitez, Tatiana, Cárdenas, Iván, Villegas, Sandra, Barrera, Nicolás, Jaramillo, Rodrigo, Botero, Nelly Beltrán López, Freddy, Trujillo, Martin, Prazny, Jitka Hasalova Zapletalova, Libor, Okenka, Dino, Alferi, Tomas, Edelsberger, Pavel, Tomanek, Jiri, Brezina, Olga, Hola, Jana, Houdova, Petr, Bucek, David, Karasek, Sarka, Kopecka, Richard, Kovar, Michal, Brada, Lucie, Hornova, Eva, Krcova, Hana, Lubanda, Vlasta, Kutejova, Jiri, Kuchar, Helena, Hrmova, Jiri, Pumprla, Magdalena, Mokrejsova, Drahomira, Gulakova, Ivo, Matyasek, Thilo, Krüger, Hermann, Haller, Thorsten, Koch, Ludger, Rose, Diethelm, Tschöpe, Lutz, Stemler, Volker, Schettler, Andreas, Pfützner, Karl, Derwahl, Thomas, Horacek, Helena, Sigal, Heidrun, Täschner, Ingolf, Schiefke, Andreas, Hagenow, Andreas, Birkenfeld, Christoph, Axthelm, Christoph, Wanner, Klaus, Busch, Heike, Schlichthaar, Christoph, Hasslacher, Stefan, Degenhardt, Markus van der Giet, Georg, Strack, Norbert, Schöll, Bernhard, R Winkelmann, Lars, Rump, Ruth, Nischik, Bernd, Schröppel, Thomas, Giebel, Achim, Ulmer, Andrea, Rinke, Christel, Contzen, Wolfgang, Jungmair, Nicole, Toursarkissian, Christof, Kloos, Joachim, Müller, Thomas, Schürholz, Hermann, Braun, Frank, Pistrosch, Per, Poulsen, Claus, Juhl, Joan, Nielsen, Jesper, Bech, Ole, Rasmussen, Peter, Rossing, Jens, Faber, Thure, Krarup, Morten, Lindhardt, Ulrik Pedersen-Bjergaard Pedersen-Bjergaard, Karoline, Schousboe, Jørgen, Hangaard, Sten, Madsbad, Gunnar, Gislason, Grzegorz Jaroslaw Pacyk, Olga González Albarrán, Carlos Sánchez Juan, José Julián Segura de la Morena, Secundino Cigarrán Guldris, Francisco Martínez Deben, José María Pascual Izuel, Julio Pascual Santos, Francesca, Calero, Alfonso, Soto, Manuel Polaina Rusillo, Josep, Redón, Josep, Galcerán, Juan, Mediavilla, Mª Dolores Martínez Esteban, Alfredo, Michán, Fernando de Álvaro, Javier Escalada San Martín, Josep Cruzado Garrit, Cristina, Castro, Fernando Cereto Castro, Rafael Santamaría Olmo, Esteban, Poch, Judith, Martins, Julio Hernández Jaras, Meritxell, Ibernón, Daniel, Seron, Hanane, Bouarich, Maribel, Troya, Jorma, Strand, Ilkka, Kantola, Sakari, Nieminen, Arvo, Koistinen, Kristiina, Kananen, Sakari, Sulosaari, Mikko, Honkasalo, Pirkko, Korsoff, Tuomo, Nieminen, Karita, Sadeharju, Kari, Humaloja, Jorma, Lahtela, Philippe, Zaoui, Jean-Pierre, Fauvel, Ronan, Roussel, Didier, Gouet, Pierre, Serusclat, Sylvaine, Clavel, Bruno, Guerci, Bruno, Verges, Olivier, Moranne, Arnaud, Monier, Alexandre, Klein, François, Chantrel, Yannick LE Meur, Rafik, Mesbah, Bertrand, Cariou, Dominique, Guerrot, Karim, Gallouj, Kieran, Mccafferty, Arutchelvam, Vijayaraman, Yuk-Ki, Wong, Dhanya, Kalathil, Sam, Rice, Sui Phi Kon, Hassan, Kahal, Cuong, Dang, Fahmy, Hanna, Christina, Kyriakidou, Imrozia, Arif, Anne, Kilvert, Pauline, Swift, Ioannis, Stefanidis, Ploumis, Passadakis, Aikaterini, Papagianni, Erifili, Hatziagelaki, Dorothea, Papadopoulou, Ioannis, Boletis, Ioanna, Makriniotou, Theodora, Kounadi, Ioannis, Ioannidis, Paul, Lee, Ching Wan Ronald Ma, Vincent, Yeung, Tai Pang Ip, Ebrahim, Noori, Julianna, Kiss, Eleonora, Harcsa, Albert, Szocs, Szilard, Vasas, Krisztina, Wudi, Robert, Kirschner, Dora, Bajcsi, Beata, Lamboy, Botond, Literati-Nagy, Gabor, Nyirati, Gizella, Petro, Karoly, Schneider, Katalin, Keltai, Akos, Kalina, Peter, Danos, Szilvia, Kazup, Zsolt, Zilahi, Judit, Simon, Laszlo, Kovacs, Marianna, Zsom, Margit, Mileder, Laszlo, Nagy, Yoram, Yagil, Julio, Wainstein, Ofri, Mosenzon, Rosane Abramof Ness, Sydney Ben Chetrit, Faiad, Adawi, Idit, Liberty, Ehud, Grossman, Mazen, Elias, Zaher, Armaly, Evgeny, Farber, Assy, Nimer, Amir, Bashkin, Gil, Chernin, Shai, Efrati, Doron, Schwartz, Noa Berar Yanay, Mariela, Glandt, Robert, Zukermann, Majdi, Halabi, Shaul, Atar, Mahmud, Darawsha, Norberto, Perico, Gaetano La Manna, Giovanni Giorgio Battaglia, Domenico, Santoro, Piermarco, Piatti, Bonora, Enzo, Davide Carlo Maggi, Paolo, Calabrò, Roberto, Cimino, Roberto, Trevisan, Paolo, Fiorina, Antonio, Pisani, Antonello, Pani, Gennaro, Santorelli, Carlo Antonio Bossi, Giancarlo, Tonolo, Enrico, Fiaccadori, Anna Maria Veronelli, Michele, Emdin, Paola, Ponzani, Maria Cristina Gregorini, Franco Luigi Cavalot, Carlo Bruno Giorda, Taro, Shibasaki, Akihiro, Hamasaki, Takashi, Nomiyama, Sunao, Matsubayashi, Junji, Shinoda, Kazunari, Matsumoto, Hideo, Kanehara, Yoshihide, Hirohata, Masayo, Yamada, Jun, Nakazawa, Yoshimitsu, Yamasaki, Mikihiro, Nakayama, Ryuichi, Furuya, Osamu, Ebisui, Satsuki, Kawasaki, Daishiro, Yamada, Masayuki, Noritake, Tamayo, Ishiko, Nobuhiro, Sasaki, Daisuke, Suzuki, Asami, Tanaka, Miyuki, Kubota, Hideo, Araki, Hiroshi, Ohashi, Takeshi, Osonoi, Kazuo, Yamagata, Naruhiro, Fujita, Daisuke, Kanda, Seiichi, Tanaka, Junko, Koide, Masao, Ishii, Takayuki, Ogiwara, Masaaki, Suzuki, Taiji, Sekigami, Takayuki, Higashi, Yuko, Yambe, Yoshiro, Kusano, Hidetoshi, Kikuchi, Hiroaki, Miyaoka, Kiyoe, Kato, Masayuki, Kashima, Fumiko, Yamakawa, Shuji, Horinouchi, Hirofumi, Imoto, Hiroshi, Sobajima, Hidetoshi, Kanai, Naoki, Matsuoka, Hirotaka, Shibata, Akemi, Inagaki, Toshiyuki, Sugiura, Toru, Sugiyama, Hidekatsu, Yanai, Yoshiyuki, Hamamoto, Masahiro, Hatazaki, Terumasa, Hayashi, Kunihisa, Kobayashi, Satoshi, Murao, Makoto, Ujihara, Kazuya, Sugitatsu, Katsunori, Kawamitsu, Ken, Yamakawa, Izumi, Tsunematsu, Fumi, Kikuchi, Hideaki, Jinnouchi, Tetsuyuki, Yasuda, Hajime, Maeda, Yasuto, Matsuo, Hideki, Okamoto, Takeshi, Katsuki, Ken, Yajima, Takeshi, Morita, Masayuki, Inagaki, Wooje, Lee, Jungoo, Kang, Cheol Young Park, Hyesoon, Kim, Singon, Kim, Youcheol, Hwang, Injoo, Kim, Jaehyeon, Kim, Young Min Cho, Byungwan, Lee, Choonhee, Chung, Soo, Lim, Jae Myung Yu, Dovile, Kriauciuniene, Antanas, Navickas, Audrone, Velaviciene, Egle, Urbanaviciene, Gediminas, Urbonas, Jurate, Lasiene, Lina, Radzeviciene, Ron, Gansevoort, Adriaan, Kooy, G Lieverse, A, L Penne, E, Ruud J, M van Leendert, M van Buren, H Boonstra, A, C Bakker, R, Marielle, Krekels, B Brouwer, C, T Luik, P, J N, M Barendregt, Bert-Jan van den Born, Trine, Finnes, Thomas, Karlsson, Hilde, Selsås, Emil, Asprusten, Robert, Hagemeier, Erik, Eriksen, Knut, Risberg, Hans, Høivik, Leidulv, Solnør, Frode, Thorup, Jan, Rocke, Rick, Cutfield, Peter, Dunn, Jeremy, Krebs, Russell, Scott, Kingsley, Nirmalaraj, Nine, Smuts, John, Baker, Veronica, Crawford, Albert, Bautista, Roberto, Mirasol, Elizabeth, Catindig, Glenda, Pamugas, Louie, Tirador, Maribel, Tanque, Janusz, Gumprecht, Piotr, Napora, Edward, Franek, Andrzej, Stankiewicz, Katarzyna, Landa, Agnieszka, Tiuryn-Petrulewicz, Kazimierz, Ciechanowski, Bogna, Wierusz-Wysocka, Barbara, Rewerska, Grazyna, Cieslik, Michal, Hoffmann, Michal, Nowicki, Jolanta, Krzykowska, Stanislaw, Mazur, Katarzyna, Wasilewska, Anna, Ocicka-Kozakiewicz, Ewa, Skokowska, Renata, Wnetrzak-Michalska, Jan, Ruxer, Patrycja, Butrymowicz, Katarzyna, Madziarska, Ilona, Kurnatowska, Teresa, Rusicka, Adam, Madrzejewski, Tomasz, Stompor, Jose, Guia, Amalia, Pereira, Pedro, Melo, Cristina, Roque, Francisco, Rosario, Fernando Teixeira, E Costa, Fernando, Nolasco, Edgar, Almeida, Pedro, Matos, Cesar, Esteves, Rui, Carvalho, Ilidio, Brandao, Susana, Heitor, Ana Vila Lobos, Rosa, Ballesteros, Gil, Silva, Carlos, Barreto, Ana, Silva, Natalya, Vorokhobina, Alexander, Sherenkov, Ivan, Gordeev, Olga, Semenova, Sergey, Levashov, Vyacheslav, Marasaev, Ruslan, Sardinov, Vadim, Klimontov, Vitaliy, Baranov, Nadezhda, Verlan, Albert, Galyavich, Arkadiy, Demko, Zhanna, Kobalava, Elena, Zakharova, Lyudmila, Kvitkova, Oleg, Solovev, Elena, Smolyarchuk, Larisa, Zhukova, Elena, Zhdanova, Andrey, Babkin, Galina, Nechaeva, Olga, Barbarash, Elena, Rechkova, Roman, Libis, Elena, Kosmacheva, Tatyana, Rodionova, Irina, Ipatko, Alexander, Dreval, Nina, Petunina, Elena, Chernyavskaya, Alsu, Zalevskaya, Yuriy, Khalimov, Tatyana, Zykova, Anton, Edin, Ashot, Mkrtumyan, Shamil, Palyutin, Vyacheslav, Mareev, Leonid, Strongin, Olga, Ukhanova, Mikhail, Antsiferov, Davyd, Yakhontov, Leonid, Pimenov, Natalya, Koziolova, Konstantin, Nikolaev, Imad, Merai, Olga, Zanozina, Leyla, Gaysina, Mikhail, Arkhipov, Natalia, Malykh, Oksana, Rymar, Vladimir, Martynenko, Sofya, Malyutina, Polina, Ermakova, Marina, Kalashnikova, Bengt-Olov, Tengmark, Carl-Johan, Lindholm, Dan, Curiac, Ken, Eliasson, Erik, Rein-Hedin, Gregor, Guron, Inga, Soveri, Annette, Bruchfeld, Jonas, Spaak, Malin, Frank, Magnus, Löndahl, Hans, Larnefeldt, Margareta, Hellgren, Olof, Hellberg, Yong Mong Bee, Chee Fang Sum, Ru San Tan, Piyamitr, Sritara, Chaicharn, Deerochanawong, Chatlert, Pongchaiyakul, Natapong, Kosachunhanan, Bancha, Satirapoj, Ahmet, Temizhan, Ibrahim, Gul, Ramazan, Sari, Aytekin, Oguz, Mustafa, Tigen, Huseyin, Yilmaz, Ozer, Badak, Oner, Ozdogan, Talat, Tavli, Necmi, Eren, Murat, Cayli, Sedat, Ustundag, Yavuz, Yenicerioglu, Ismail, Kocyigit, Abdulbaki, Kumbasar, Idris, Sahin, Lee-Ming, Chuang, Ju-Ying, Jiang, Chien-Te, Lee, Der-Cherng, Tarng, Shih-Te, Tu, Mai-Szu, Wu, Ming-Ju, Wu, Chiz-Tzung, Chang, Cheng-Chieh, Hung, Liubov, Sokolova, Borys, Mankovsky, Dmytro, Kogut, Viktoriia, Chernikova, Kateryna, Malyar, Nonna, Kravchun, Volodymyr, Botsyurko, Vitaliy, Maslyanko, Liliya, Martynyuk, Oleksandr, Serhiyenko, Vasyl, Stryzhak, Halyna, Myshanych, Oleksandra, Donets, Iryna, Bondarets, Maryna, Vlasenko, Nataliia, Pertseva, Mariia, Grachova, Ivan, Smirnov, Larysa, Pererva, Ivan, Fushtey, Julia, Komisarenko, Anna, Isayeva, Carl, Meisner, Bobby, Khan, Louis, Maletz, Bradley, Dixon, Ahmed, Arif, Timothy, Jackson, Mirela, Ponduchi, Mahfouz El Shahawy, Salil, Nadkarni, Daniel, Urbach, Jorge, Paoli-Bruno, Henry, Lora, Umar, Farooq, Steven, Zeig, Lance, Rudolph, Nabil, Andrawis, William, Kaye, Jill, Meyer, Khalid, Bashir, Glenn, Heigerick, James, Smelser, Javier Ricardo Colomar, David, Scott, Brian, First, Stuart, Handelsman, Jose, Bautista, Rajesh, Patel, Stephen, Minton, Juan, Frias, Luis, Ramos-Gonez, John, Bertsch, Ali, Iranmanesh, Vivian, Fonseca, Michael, Yuryev, Larry, Popeil, Jose, Cardona, Sanjeev, Saxena, Santosh, Sharma, Edgar, Gonzalez, Richard, Solomon, Muhammad, Khan, Ahmed, Awad, David, Fitz-Patrick, Douglas, Linfert, David, Grant, Susan, Brian, Leon, Fogelfeld, Rafael, Canadas, Pablo, Pergola, Joseph, Soufer, Rakesh, Patel, Shujauddin, Valika, Jonathan, Winston, Allison, D, Maria, Caramori, Stanley, Koch, Anjay, Rastogi, Jonathan, Bornfreund, Michael, Rocco, Maxine, Hamilton, Luis, Garcia-Mayol, Peter, Weissman, Suzanne, Oparil, Gary, Ruoff, Kyaw, Soe, Gary, Korff, Robert, Busch, Alexander, Lurie, Israel, Hartman, Garfield, Samuels, Derek, Lejeune, Visal, Numrungroad, Stephen, Brietzke, Zeid, Kayali, Harold, Szerlip, Steven, Barag, Gilberto, Seco, Damaris, Vega, Osvaldo, Brusco, Camil, Kreit, Humberto, Cruz, Bharat, Mocherla, Sharma, Prabhakar, George, Fadda, Martin, Valdes, Eugene, Soroka, Ramin, Berenji, Sreedhara, Alla, Shweta, Bansal, Odugbesan, A, Karlton, Pettis, Masoud, Azizad, Idalia, Acosta, Atoya, Adams, William, Sanchez, Rosa, Suarez, Efrain, Reisin, Carlos, Herrera, Keung, Lee, Csaba, Kovesdy, Adam, Whaley-Connell, Aldo, Peixoto, Ronald, Mayfield, Mahendra, Jain, Earl, Martin, Paul, Norwood, Jonathan, Wise, Hugo, Romeu, Stephen, Halpern, Mustafa, Mandviwala, Thomas, Turk, Anna, Burgner, David, Bleich, Ankur, Doshi, Jose, Carpio, Jorge, Posada, Alexander, Magno, Samer, Nakhle, Gary, Goldstein, Caroline, Mbogua, Dierdre, Mcmullen, Dilawar, Ajani, Wayne, Kotzker, Nelson, Kopyt, Richard, Treger, Yusuf, Ruhullah, Sharon, Adler, Harjeet, Brar, Marc, Rendell, Dennis, Ross, Srinivasan, Beddhu, German, Hernandez, Sylvia, Rosas, M Sue Kirkman, Mohammed, El-Shahawy, Jeffrey, Rothman, Ahmad, Barakzoy, Aparna, Tamirisa, Sabrina, Benjamin, Michael, Bahrami, Prabir, Roy-Chaudhury, Ramprasad, Dandillaya, Gretel, Trullenque, Jose, Birriel, John, Flack, Karen, Johnson, Brenda, Lemus, Guillermo, Umpierrez, Geetha, Maddukuri, Kenneth, Jamerson, Christopher, Case, Patrick, Fluck, Saeed, Kronfli, Violet, Habwe, Bala, Subramanian, Tariq, Shafi, Rupesh, Raina, Roland, Fernando, Sourabh, Kharait, Carlos, Hernandez-Cassis, Raymond, Fink, Jamal, Hammoud, Amer, Al-Karadsheh, Manuel, Montero, Philip, Nicol, Jesus, Navarro, Michael, Shanik, Zia, Din, Francisco, Gonzalez-Abreu, Sam, Lerman, Claude, Galphin, John, Evans, Ashwini, Gore, Radica, Alicic, Mandeep, Sahani, Roberto, Pisoni, Tuan-Huy, Tran, Jeffrey, Ryu, Harvey, Serota, Nilda, Neyra, Richard, O Donovan, Sreedhar, Mandayam, Moustafa, Moustafa, Mark, Smith, Arvind, Krishna, Arjun, Sinha, Anuj, Bhargava, Kodangudi, Ramanathan, Soni, Dhanireddy, Stephen, Thomson, Romanita, Nica, Emaad, Abdel-Rahman, Mark, Barney, Mariana, Markell, Nauman, Shahid, David, Oliver, Tran, Khanh, Pham Nguyen Son, Lam VAN Hoang, Boi Ngoc Nguyen, Nguyen Minh Nui, Lan Phuong Tran, Fayzal, Ahmed, Dorothea, Urbach, Dirkie Jansen van Rensburg, Gracjan, Podgorski, Aslam, Amod, Sindeep, Bhana, Shaifali, Joshi, Essack, Mitha, Deepak, Lakha, Louis van Zyl, Trokis, J, Naresh, Ranjith, Mary, Seeber, Mohamed, Sarvan, Mohammed, Tayob, Brian, Rayner, Larry, Distiller, Heidi, Siebert, Mukesh, Joshi, Paul, Rheeder, Magdalena Madero Rovalo, Gustavo Solache Ortiz, Gustavo Méndez Machado, Rafael Valdez Ortiz, Juan Villagordoa Mesa, Saúl Irizar Santana, Sandro Avila Pardo, Jorge Escobedo de la Peña, Guillermo González Gálvez, Leobardo Sauque Reyna, Miriam Bastidas Adrian, Guillermo Fanghänel Salmón, Ramiro Gutiérrez Ochoa, Luis Nevarez Ruiz, Gabriel Ramos López, Alfredo Chew Wong, Arturo Saldaña Mendoza, Pedro García Hernández, José González González, Melchor Alpizar Salazar, José Lazcano Soto, Amaury, Roman-Miranda, Gregorio, Cortes-Maisonet, Liana, Turcu, Adriana, Dumitrescu, Gabriela, Radulian, Hortensia, Barbonta, Cristina, Mistodie, Georgeta, Vacaru, Alexandrina, Popescu, Adrian, Vlad, Silvia, Paveliu, Nicoleta, Mindrescu, Adrian, Albota, Ella, Pintilei, Lavinia, Pop, Gabriela, Negrisanu, Doina, Catrinoiu, Cornelia, Bala, Amorin, Popa, Iosif, Szilagyi, Ciprian, Constantin, Elena, Caceaune, Adriana, Onaca, Li Yuan Lee, Nor Azizah Aziz, Wan Mohd Izani Wan Mohamed, Wan Hasnul Halimi Bin Wan Hasan, Jeyakantha, Ratnasingam, Nik Nur Fatnoon Nik Ahmad, Rizmy Najme Khir, Norhaliza Mohd Ali, Masni, Mohamad, Chek Loong Loh, Joe, Eustace, John, Holian, Donal, Reddan, Yvonne, O Meara, Mensud, Hatunic, Zuzana, Ochodnicka, Dalibor, Sosovec, Andrej, Dzupina, Ingrid, Buganova, Jana, Babikova, Denisa, Spodniakova, Ruilope, L, Agarwal, R, Anker, S, Bakris, G, Filippatos, G, Nowack, C, Kolkhof, P, Joseph, A, Mentenich, N, Pitt, B, Trevisan, R, Pathology/molecular and cellular medicine, Diabetes Pathology & Therapy, and Diabetes Clinic

Subjects
Male, Endocrinology, Diabetes and Metabolism, Enfermedad cardiovascular, 030232 urology & nephrology, BAY 94-8862, Type 2 diabetes, 030204 cardiovascular system & hematology, Diabete, Kidney, Aparato circulatorio, Azúcar, chemistry.chemical_compound, Mineralocorticoid Receptor Antagonists/therapeutic use, 0302 clinical medicine, Medicine and Health Sciences, Diabetic Nephropathies, Myocardial infarction, Renal Insufficiency, Chronic, Aldosterone, Outcome, Mineralocorticoid Receptor Antagonists, RISK, COMPLICATIONS, Diabetes, Middle Aged, SPIRONOLACTONE, CHRONIC HEART-FAILURE, Treatment Outcome, Mineralocorticoid, Nephrology, Cardiovascular Diseases, Research Design, Disease Progression, Female, medicine.symptom, Cardiology and Cardiovascular Medicine, Type 2, Glomerular Filtration Rate, medicine.medical_specialty, Finerenone, Naphthyridines/therapeutic use, Renal function, Outcomes, 03 medical and health sciences, Clinical, Double-Blind Method, Diabetes mellitus, Internal medicine, medicine, Diabetes Mellitus, Humans, Naphthyridines, Renal Insufficiency, Chronic, ANTAGONIST, Sistema cardiovascular, Aged, Patient-Oriented, Translational Research: Research Article, Diabetic Nephropathies/complications, Renal Insufficiency, Chronic/drug therapy, RECEPTOR, Aldosterone, Clinical, Diabetes, Kidney, Mineralocorticoid, Outcomes, business.industry, Cardiovascular Diseases/epidemiology, Diabetes Mellitus, Type 2/complications, MILD, WORSENING RENAL-FUNCTION, EFFICACY, medicine.disease, chemistry, Diabetes Mellitus, Type 2, Spironolactone, Albuminuria, business, Kidney disease, Follow-Up Studies
Abstract

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate ≥25 mL/min/1.73 m2 and albuminuria (urinary albumin-to-creatinine ratio ≥30 to ≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049.

Published
2019
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41. Dyslipidaemias and their treatment in high complexity centres in Colombia

Author

Edwin Etayo, Hernando Vargas-Uricoechea, Hernán Yupanqui Lozano, Alberto Cadena, Gustavo Parra, Miguel Urina-Triana, Alejandro Román-González, Rodrigo Botero, Daniel Isaza, Juan Manuel Toro, Adalberto Quintero, Dora I. Molina, Alvaro Mauricio Quintero, Mónica Jaramillo, Boris Eduardo Vesga-Angarita, Juan M. Cárdenas, Alonso Merchán, Álvaro J. Ruiz, Juan M. Arteaga, Mónica Betancur-Valencia, and Etna Valenzuela-Plata

Subjects
Male, medicine.medical_specialty, Statin, medicine.drug_class, Atorvastatin, Objective data, Colombia, Retrospective data, High complexity, Internal medicine, medicine, Humans, In patient, Rosuvastatin, cardiovascular diseases, General Environmental Science, Aged, Dyslipidemias, Hypolipidemic Agents, Retrospective Studies, Aged, 80 and over, business.industry, General Engineering, nutritional and metabolic diseases, Cholesterol, LDL, Middle Aged, medicine.disease, Comorbidity, Cross-Sectional Studies, General Earth and Planetary Sciences, lipids (amino acids, peptides, and proteins), Female, Hydroxymethylglutaryl-CoA Reductase Inhibitors, business, medicine.drug
Abstract

Background and objective Data is scarce on the distribution of different types of dyslipidaemia in Colombia. The primary objective was to describe the frequency of dyslipidaemias. The secondary objectives were: frequency of cardiovascular comorbidity, statins and other lipid-lowering drugs use, frequency of statins intolerance, percentage of patients achieving c-LDL goals, and distribution of cardiovascular risk (CVR). Materials and methods Cross-sectional study with retrospective data collection from 461 patients diagnosed with dyslipidaemia and treated in 17 highly specialised centres distributed into six geographic and economic regions of Colombia. Results Mean (SD) age was 66.4 (±12.3) years and 53.4% (246) were women. Dyslipidaemias were distributed as follows in order of frequency: mixed dyslipidaemia (51.4%), hypercholesterolaemia (41.0%), hypertriglyceridaemia (5.4%), familial hypercholesterolaemia (3.3%), and low c-HDL (0.7%). The most prescribed drugs were atorvastatin (75.7%) followed by rosuvastatin (24.9%). As for lipid control, 55% of all patients, and 28.6% of those with coronary heart disease, did not achieve their personal c-LDL goal despite treatment. The frequency of statin intolerance was 2.6% in this study. Conclusions Mixed dyslipidaemia and hypercholesterolaemia are the most frequent dyslipidaemias in Colombia. A notable percentage of patients under treatment with lipid-lowering drugs, including those with coronary heart disease, did not achieve specific c-LDL goals. This poor lipid control may worsen patient's CVR, so that therapeutic strategies need to be changed, either with statin intensification or addition of new drugs in patients with higher CVR.

Published
2019

42. Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial

Author

Hertzel C Gerstein, Helen M Colhoun, Gilles R Dagenais, Rafael Diaz, Mark Lakshmanan, Prem Pais, Jeffrey Probstfield, Fady T Botros, Matthew C Riddle, Lars Rydén, Denis Xavier, Charles Messan Atisso, Leanne Dyal, Stephanie Hall, Purnima Rao-Melacini, Gloria Wong, Alvaro Avezum, Jan Basile, Namsik Chung, Ignacio Conget, William C Cushman, Edward Franek, Nicolae Hancu, Markolf Hanefeld, Shaun Holt, Petr Jansky, Matyas Keltai, Fernando Lanas, Lawrence A Leiter, Patricio Lopez-Jaramillo, Ernesto German Cardona Munoz, Valdis Pirags, Nana Pogosova, Peter J Raubenheimer, Jonathan E Shaw, Wayne H-H Sheu, Theodora Temelkova-Kurktschiev, Mercedes Abella, Andrea Alebuena, Sandra Almagro, Eduardo Amoroso, Paula Anadon, Elizabeth Andreu, Guillermo Aristimuño, Maria Arzadun, Maria Barbieri, Raul Barcudi, Ines Bartolacci, Gabriel Bolobanich, Anselmo Bordonava, Miguel Bustamante Labarta, Betina Bustos, Alberto Caccavo, Alejandra Camino, Maria Cantero, Maria Carignano, Luis Cartasegna, Marcela Cipullo, Víctor Commendatore, Victoria Conosciuto, Osvaldo Costamagna, Claudia Crespo, Jose Cuello, Carlos Cuneo, Sandra Cusimano, Sofia Dean, Claudio Dituro, Andrea Dominguez, Miguel Farah, Alberto Fernandez, Florencia Fernandez, Adriana Ferrari, Patricia Flammia, Jose Fuentealba, Karina Beatriz Gallardo, Celso Garcia, Ruben Garcia Duran, Marcelo Garrido, Rodolfo Gavicola, Claudio Gerbaudo, Graciela Gilli, Ana Paula Giotto, Pedro Godoy Bolzán, Oscar Gomez Vilamajo, Fernando Guerlloy, Cristian Guridi, Narcisa Gutierrez Garrido, Eduardo Hasbani, Sonia Hermida, Miguel Hominal, Adrian Hrabar, Adrián Ingaramo, Alejandra Izzicupo, Mario Krynski, Mariana Lagrutta, Paulina Lanchiotti, Maria Langhe, Veronica Leonard, Javier Llanos, Ricardo Lopez Santi, Jorge Lowenstein, Cecilia Luquez, Ignacio Mackinnon, Melina Mana, Sara Manzur, Javier Marino, Carolina Martella, Roger Martinez, Re Matias, Javier Matkovich, Monica Meritano, Oscar Montaña, María Mulazzi, Juan Ochoa, Gustavo Paterlini, María Pelagagge, Maria Elena Peralta Lopez, Aldo Prado, Lorena Pruyas, Martín Racca, Carola Ricotti, Carolina Rodriguez, Mariano Romero Vidomlansky, Ricardo Ronderos, Ana Laura Sadowski, Jorgelina Sala, Alejandro Sánchez, Andrea Santoro, Lilia Schiavi, Mariano Sein, Virginia Sernia, Leonardo Serra, Maximiliano Sicer, Tomas Smith, Leonardo Soso, Georgina Sposetti, Andrea Steinacher, Jorge Stival, Jorge Tedesco, Hugo Tonin, Mauro Tortolo, Maria Ulla, Julio Vallejos, Marisa Vico, Luciana Virgillito, Virginia Visco, Daniel Vogel, Florencia Waisman, César Zaidman, Noemi Zucchiatti, Imran Badshah, Neale Cohen, Peter Colman, David Colquhoun, Timothy Davis, Spiros Fourlanos, Greg Fulcher, Jane Hamlyn, Cilla Haywood, Samantha Hocking, Maeve Huchinson, William Jeffries, Mervyn Kyl, Clement Lo, PeakMann Mah, Ashley Makepeace, Dolly Marope, Natalie Nanayakkar, Alison Nankervis, Neil Palmer, Barbara Palolus, Satish Pillai, Sarah Price, Joseph Proietto, Anne Reutens, Natassia Rodrigo, Abdul Sheikh, Greg Smith, Michelle So, Georgia Soldatos, Bronwyn Stuckey, Priya Sumithran, Helena Teede, Parind Vora, Lyn Williams, Eduardo Abib, Christiani Adão Poço, Érica Ferreira Alves, Janaina Andreatta Bernardi Barea, Livia Avezum Oliveira, Denise Ludovico da Costa de Castro, Ivan Correa da Cruz, Midiã Costa, Ivan Cruz, Sidney Cunha, Marco Antonio Vieira Da Silva, Renata de Carvalho Camara Bona, Bruna de Paula, Freddy Eliaschewitz, Guilherme Fazolli, Carlos Alberto Ferreira Filho, Jose Fortes, Cesar França, Denise Reis Franco, Paulo Roberto Genestreti, Flavio Giorgeto, Rodrigo Marques Gonçalves, Michele Elka Grossman, Ana Claudia Henrique Marcelino, Mauro Hernandes, Ana Horta, Cristiano Jaeger, Midia Kaneblai, Cecilia Kauffman Rutenberg, Jose Francisco Kerr Saraiva, Maria Angelica Lemos, Lilia Maia, Euler Roberto Manenti, Mariana Marques, Cynthia Melissa Valerio, Rodrigo Moreira, Flávia Mothé, Osana Maria Mouco, Philip Moura, José Carlos Moura Jorge, Carlos Nakashima, Marcelo Nakazone, Thiago Napoli, Cristiane Nunes, Joao Eduardo Nunes Salles, Karla Oliveira, Marcela Oliveira, Gracielly de Souza Pantano, Fabio Petri, Leonardo Piazza, Andreia Carla Pires, Patricia Pizzato, Sergio Prata, Dalton Precoma, Rafael Rech, Gilmar Reis, Heleno Reis, Elisabete Resende, Jose Ribas Fortes, Sylka Rodovalho, Fabio Rossi dos Santos, Joao Eduardo Salles, Célia Regina Sampaio, Thiago Santos, Vanessa Santos dos Santos, Tulio Silva e Quadros, Daniel Silveira, Katia Nunes Siqueira, M Teireira, Marcelo Uehara, C Valerio, Henrique Vianna, Maria Helena Vidotti, Guilherme de Lima Visconti, Maria Teresa Zanella, Viktoriya Andreeva, Radoslav Borisov, Nikolay Botushanov, Georgi Dimitrov, Kameliya Dimova, Tsvetan Dragoychev, Valentina Grigorova, Valentina Gushterova, Ivaylo Ivanov, Tatyana Kocelova, Dimo Kurktschiev, Milena Miletieva, Neli Nenkova-Gugusheva, Ralitsa Pancheva, Maria Pavlova, Dimitar Raev, Vesela Spasova, Anastas Stoikov, Dimitar Troev, Todor Yanev, Mariana Yoncheva-Mihaylova, Alexander Abitbol, Buki Ajala, Abdullh Alguwaihes, Jean-Luc Ardilouze, Nahla Aris-Jilwan, Amel Arnaout, Ronnie Aronson, Nadeem Aslam, Sandra Babin, Jean-Patrice Bailargeon, Allan Bailey, Harpreet Bajaj, Christian Beauchesne, Sorin Beca, Andre Belanger, Alan Bell, Diego Bellabarba, Lori Berard, Brian Berenbaum, Vincent Bergeron, Joseph Berlingieri, Frédéric Bernier, Phoebe Bishara, David Blank, Ian Blumer, Suzanne Brault, Donald Breton, André Carpentier, James Cha, Prakash Chandra, Jean-Louis Chiasson, James R Conway, Ghyslaine Couture, Nathalie Couture, Gilles Dagenais, Dyotirmoy Datta, Giuseppe D'Ignazio, Richard Dumas, Didier Fay, Andre Frechette, Louise Frenette, Daisy Fung, Nathalie Gagnon, Meri Galter, Jean Garon, Jean Sebastien Gauthier, Christian Geadah, Jeremy Gilbert, Ronald Girard, Ronald Goldenberg, Loren David Grossman, Nikhil Gupta, Jean-Pierre Halle, Marie-France Hivert, Ghislaine Houde, Robyn Houlden, Irene Hramiak, Ted Jablonski, Akshay Jain Jain, Hasnain Khandwala, Munish Khosla, C Lachance, Emilie Laflamme, Marie-France Langlois, Luc Larivee, Joanne Liutkus, Heather Lochnan, Saleem Malik, Charlotte McDonald, Pravinsagar Mehta, John Mihailidis, Alain Milot, Priya Narula, Patrice Nault, Arun Nayar, William Nisker, Gilles Ouellet, Jean Palardy, Minta Patel, Terri Paul, Sue Pedersen, Patrice Perron, Marie-Hélène Pesant, Paul Poirier, Marie-Claude Poulin, Zubin Punthakee, Waheed Rehman, Stuart Ross, P Sagar, Nouhad Saliba, Sam Sandler, Alicia Schiffrin, Robert Schlosser, Anila Seth-Sharma, Mark Sherman, David Sionit, Tharsan Sivakumar, Juan Soto, Eric St-Amour, Oren Steen, Jack Sussman, Adam Telner, Sheldon Tobe, David-Yaw Twum-Barima, Audrey Van Zanten, Nicole VanRossum, Jonathan Vecchiarelli, Rick Ward, John Wessengel, Stanley Weisnagel, Igor Wilderman, Vincent Woo, Natalia Yakubovich, Jean-Francois Yale, Zeina Yared, Monica Acevedo, Maria Loreto Aguirre, Andres Aizman, Maria Soledad Barroso, Leonardo Cobos, Alfredo Danin Vargas, Barbara Descalzi, Gonzalo Godoy, Elio Grumberg, Rodolfo Lahsen, Gladys Larenas, Eugenia Ortiz, Javier Paredes, Sergio Potthoff, Eva Retamal, Luis Rojas, Manuel Salgado, Claudio Santibanez, Carmen Solis, Benjamin Stokins, Jose Accini, Javier Acebedo, Lina Maria Agudelo Baena, Soraya Alarcon, Juliana Angel, Edgar Arcos, M Aroca Martinez, Leonor Atuesta, Jose Balaguera, Doris Ballestas, Sandra Isabel Barrera, Rosmy Barrios Reyes, Adolfo Bayona, Andres Bermudez, Diego Zarate Bernal, Marco Blanquicett, Victor Bravo, Wendy Bueno, Alvaro Burbano Delgado, Alberto Cadena, Andres Cadena, Sandra Caicedo, Carlos Celemin, Ricardo Consuegra, Cristhian Contreras Pimienta, Kelly Johenis Corredor, Carlos Cure, Lizeth Dayana De La Hoz Rueda, Erika Delgado, Sarahy Diaz, Marta Diego, Anabell Donado, William Encinales Sanabria, Juliana Escobar, Gillian Escorcia, Leonardo Forero, Laura Fuentes, Maria Garcia, Henry Garcia Lozada, Luis Garcia Ortiz, Angela Giraldo, Laura Gomez Gonzalez, Javier Granada, Corina Gutierrez, Natalia Henao, Edwin Hernandez, Olga Maria Herrera Uejbe, Juan Diego Higuera Cobos, Jaime Ibarra Gómez, Edwin Hernandez Jaimes, Monica Jaramillo, Nicolas Jaramillo, Carlos Jaramillo Gomez, Monica Jaramillo Sanchez, Ivonne Jarava Durán, Catalina Lopez Ceballos, Claudia Madrid, Elias María Amastha, Jennifer Mercado, Dora Ines Molina, Jessica Molina Soto, Carlos Montoya, Alexander Morales, Carolina Muñoz, Luis Alejandro Orozco, Oscar Osorio, Jorge Mario Palmera Sanchez, Adwar Peña, Jose Perez, Juan Perez Agudelo, Germán Pérez Amador, Carlos Pertuz, Irina Posada, Carlos Puerta, Adalberto Quintero, Diana Quiroz, Carmen Rendon, Alberto Reyes, Alvaro Reyes, Diana Ripoll, Carlos Rivera, Maria Rocha, Jose F Rodriguez, Kervis Asid Rodriguez Villanueva, Javier Emilio Rodriguez Zabala, Sindy Rojas, Maria Romero, Ricardo Rosero, Angelica Rocio Rosillo Cardenas, Lina Rueda, Gregorio Sanchez, Tatiana Sanchez, Arístides Sotomayor Herazo, Monica Suarez, Mariana Torres, Freddy Trujillo, Miguel Urina, Lazaro Van Strahlen, Carlos Velandia, Carolina Velasquez Guzman, Elizabeth Velazquez, Tatiana Vidal Prada, Juan Pablo Yepez Alvaran, Diego Zarate, Jana Andelova, Radka Benesova, Barbara Buzova, Vladimir Cech, Ida Chodova, Miroslav Choura, Antonin Dufka, Andrea Gamova, Jakub Gorgol, Tomas Hala, Hana Havlova, Dagmar Hlavkova, Petra Horanska, Juliana Ilcisin-Valova, Petra Jenickova, Ondrej Jerabek, Ilona Kantorova, Katerina Kolomaznikova, Iva Kopeckova, Miroslava Kopeckova, Karel Linhart, Tomas Linhart, Jan Malecha, Emilia Malicherova, Dana Neubauerova, Martina Oznerova, Radan Partys, Eva Pederzoliova, Maria Petrusova, Vera Prymkova, Eva Racicka, Ida Reissova, Eva Roderova, Libor Stanek, Alena Striova, Dana Svarcova, Petr Svoboda, Emilia Szeghy Malicharova, Jan Urge, Ladislav Vesely, Bedich Wasserburger, Hilde Wasserburgerova, Emil Zahumensky, Vaclav Zamrazil, Hasan Alawi, Ernestos Anastasiadis, Elisabeth Axthelm, Tasso Bieler, Christina Buhrig, Elizaveta Degtyareva, Frank Dellanna, Karl-Michael Derwahl, Stephan Diessel, Barbara Dogiami, Kirsten Dorn-Weitzel, Monika Ernst, Grit Faulmann, Baerbel Fetscher, Thomas Forst, Gabriele Freyer-Lahres, Klaus Funke, Xenia Ganz, Christiane Gleixner, Christoph Hanefeld, Sven Heinrichs, Stephanie Helleberg, Elena Henkel, Gerd Ruediger Hetzel, Caren Hoffmann, Frohmut Jacob, Stephan Jacob, Franziska John, Antonius Jonczyk, Wolfram Kamke, Christiane Klein, Martina Kleinhardt, Werner Kleophas, Christine Kosch, Kristin Kreutzmann, Achim Kühn, Young Hee Lee-Barkey, Alexander Lier, Sarah Maatouk, Joachim Minnich, Michael Mitry, Ilona Muessig, Diana Nicula, Martina Niemann, Joerg Nothroff, Petra Ott, Andreas Pfuetzner, Andreas Pfützner, Frank Pistrosch, Wildgard Pohl, Zdenka Prochazkova, Marlena Retkowska, Heiko Rosin, Daniela Sachsenheimer, Holger Samer, Mazin Sanuri, Axel Schaefer, Frank Schaper, Erik-Delf Schulze, Marita Schulze, Martina Schumann, Thomas Segiet, Veronika Sowa, Hans-Detlev Stahl, Franziska Steinfeldt, Madlen Teige, Bjoern Trieb, Diethelm Tschoepe, Peter Uebel, Bernd Warken, Ingo Weigmann, Klaus Weyland, Klara Wilhelm, Timea Balo, Miklos Balsay, Ilona Bende, Katalin Bezzegh, Zita Birkus, Barbara Buday, Melinda Csomai, Laszlo Deak, Eniko Dezso, Peter Faludi, M Faluvegi, Ilona Fazekas, Agota Feher, Csaba Fejer, Ervin Finta, Agnes Fulcz, Zsolt Gaal, Mihaly Gurzo, Krisztina Hati, Gabriella Herczeg, Ildiko Jozsef, Marta Juhasz, Katalin Keltai, Laszlo Koranyi, Eniko Kulcsar, Krisztina Kun, Andrea Laczko, Botond Literáti-Nagy, Izabella Mezo, Margit Mileder, I Moricz, Károly Nagy, Bela Nagybaczoni, Csaba Nemeth, Agnes Oze, Jozsef Pauer, Eva Peterfai, Bela Polocsanyi, Ferenc Poor, István Reiber, Csaba Salamon, Julia Sebestyen, Ildiko Torok, Marianna Tuu, Andrea Varga, Viktor Vass, Chul Min Ahn, Chulwoo Ahn, Park ByungWon, Hyuk-Jae Chang, Kiyuk Chang, Eui-Young Choi, Han Seok Choi, Jin-Wook Chung, Bum- Kee Hong, Young Joon Hong, Min Su Hyon, Myung Ho Jeong, Shinae Kang, Byeong-Keuk Kim, Ji-Hyun Kim, Ju Han Kim, Kee-Sik Kim, Moo Hyun Kim, Pum-Joon Kim, Soon-Kil Kim, Yong-Seok Kim, Young Kwon Kim, Yoon Seok Koh, Hyuck Moon Kwon, Byoung Kwon Lee, Byung-Wan Lee, Jin Bae Lee, Myoung-Mook Lee, Young-Mee Lim, Pil Ki Min, Jong Sung Park, Jongsuk Park, Keun Ho Park, Sungha Park, Wook Bum Pyun, Se Joong Rim, Dong-Ryeol Ryu, Hong-Seog Seo, Ki Bae Seung, Dong-Ho Shin, Doo Sun Sim, Young Won Yoon, Ilze Andersone, Kristine Babicka, Inga Balcere, Roberts Barons, Inguna Capkovska, Kristine Geldnere, Inese Grigane, Baiba Jegere, Ilze Lagzdina, Lija Mora, Sigita Pastare, Rota Ritenberga, Janina Romanova, Inta Saknite, Natalja Sidlovska, Jelena Sokolova, Sandra Steina, Iveta Strizko, Dace Teterovska, Brigita Vizina, Lina Barsiene, Gintare Belozariene, Laura Daugintyte-Petrusiene, Nijole Drungiliene, Nijole Garsviene, Ala Grigiene, Vytautas Grizas, Virginija Jociene, Dalia Kalvaitiene, Jugeta Kaupiene, Jurate Kavaliauskiene, Dalia Kozloviene, Ilona Lapteva, Birute Maneikiene, Jolanta Marcinkeviciene, Vaidilija Markauskiene, Salomeja Meiluniene, Almantas Norkus, Rita Norviliene, Vladimiras Petrenko, Ruta Radzeviciene, Gintare Sakalyte, Gediminas Urbonas, Skaiste Urbutiene, Donatas Vasiliauskas, Dzilda Velickiene, Carlos Aguilar, Marco Alcocer, Juan Antonio Avalos-Ramirez, Ramiro Banda-Elizondo, Rubria Bricio-Ramirez, Karla Cardenas Mejia, Francisco Cavazos, Jesus Chapa, Erika Cienfuegos, Astrid De la Peña, Gilberto de la Peña Topete, Manuel Odin De los Rios Ibarra, Daniel Elias, Claudia Flores-Moreno, Pedro Garcia Hernandez, Luis Gerardo Gonzalez, Rosa Linda Guerra Moya, Arturo Guerra-Lopez, Raymundo Hernandez Baylon, Carolina Herrera Colorado, Marisol Herrera-Marmolejo, Neri Islas-Palacios, Esteban Lopez, Fernando Lopez, Agustin Lopez Alvarado, Rosa Isela Luna Ceballos, Enrique Morales Villegas, Gualberto Moreno-Virgen, Rosa Linda Parra Perez, Sara Pascoe Gonzalez, Irving Peralta-Cantu, Roopa Previn, Rosa Ramirez, Rubria Ramirez, Maria Guadalupe Ramos Zavala, Monica Rodriguez, Rocio Salgado-Sedano, Ana Claudia Sanchez-Aguilar, Edith Santa Rosa Franco, Leobardo Sauque-Reyna, Rodrigo Suarez Otero, Ivonne Torres, Enrique Velarde-Harnandez, Juan Villagordoa, Efrain Villeda-Espinoza, Jorge Vital-Lopez, Cristian Jair Zavala- Bello, John Baker, Elaine Barrington-Ward, Thomas Brownless, Richard Carroll, Simon Carson, Michelle Choe, Andrew Corin, Brian Corley, Richard Cutfield, Neelam Dalaman, Paul Dixon, Paul Drury, Keith Dyson, Chris Florkowski, Monica Ford, William Frengley, Colin Helm, Colin Katzen, Jane Kerr, Manish Khanolkar, David Kim, Renata Koops, Jeremy Krebs, Robert Leikis, Kwan Low, Alison Luckey, Richard Luke, Susan Macaulay, Rodney Marks, Catherine McNamara, Dean Millar-Coote, Steven Miller, Naomi Mottershead, James Reid, Narcisa Robertson, Ian Rosen, David Rowe, Ole Schmiedel, Russell Scott, Jeffrey Sebastian, Davitt Sheahan, Victoria Stiebel, Ian Ternouth, Chris Tofield, Dirk Venter, Michael Williams, Miles Williams, Fiona Wu, Simon Young, Malgorzata Arciszewska, Anna Bochenek, Piotr Borkowski, Przemyslaw Borowy, Tomasz Chrzanowski, Edward Czerwinski, Marek Dwojak, Agnieszka Grodzicka, Izabela Janiec, Joanna Jaruga, Ewa Krystyna Jazwinska-Tarnawska, Krystyna Jedynasty, Danuta Juzwiak-Czapiewska, Jadwiga Karczewicz-Janowska, Jan Konieczny, Marek Konieczny, Marek Korol, Maciej Kozina, Ewa Krzyzagorska, Ewa Kucharczyk-Petryka, Roman Laz, Anna Majchrzak, Zdzislawa Mrozowska, Michal Mularczyk, Elzbieta Nowacka, Jadwiga Peczynska, Robert Petryka, Radoslaw Pietrzak, Dorota Pisarczyk-Wiza, Aleksandra Rozanska, Zofia Ruzga, Emilia Rzeszotarska, Malgorzata Sacha, Marzenna Sekulska, Anna Sidorowicz-Bialynicka, Teresa Stasinska, Agnieszka Strzelecka-Sosik, Teresa Swierszcz, Katarzyna Miroslawa Szymkowiak, Olga Turowska, Krystyna Wisniewska, Maciej Wiza, Iwona Wozniak, Katarzyna Zelazowska, Bernadetta Ziolkowska-Gawron, Danuta Zytkiewicz-Jaruga, Adrian Albota, Carmina Alexandru, Rodica Avram, Cornelia Bala, Diana Barbonta, Roxana Barbu, Daniela Braicu, Nicoleta Calutiu, Doina Catrinoiu, Anca Cerghizan, Alina Ciorba, Anca Craciun, Rodica Doros, Livia Duma, Ancuta Dumitrache, Ioana Ferariu, Anca Ferician Moza, Alexandrina Ghergan, Gheorghe Ghise, Mariana Graur, Mihaela Gribovschi, Bogdan Mihai, Laura Mihalache, Madalina Mihalcea, Nicoleta Mindrescu, Magdalena Morosanu, Andrea Morosoanu, Maria Mota, Anca Moza, Valerica Nafornita, Narcisa Natea, Simona Nicodim, Cristina Nita, Adriana Onaca, Mircea Onaca, Cristina Pop, Lavinia Pop, Amorin Popa, Alexandrina Popescu, Luchiana Pruna, Gabriela Roman, Mihaela Rosu, Alexandra Sima, Doina Sipciu, Carmen Narcisa Sitterli-Natea, Iosif Szilagyi, Minodora Tapurica, Adrian Tase, Adriana-Carmen Tutescu, Luminita Vanghelie, Ioana Verde, Adrian Vlad, Mihaela Zarnescu, Roman Akhmetov, Irina Allenova, Irina Avdeeva, Oksana Baturina, Irina Biserova, Nikolay Bokovin, Irina Bondar, Natalia Burova, Galina Chufeneva, Elena Chumachek, Marina Demidova, Alexander Demin, Vera Drobysheva, Irina Egorova, Lev Esenyan, Ekaterina Gelig, Sergey Gilyarevsky, Maria Golshmid, Arseniy Goncharov, Anastasia Gorbunova, Ivan Gordeev, Vera Gorelysheva, Tatiana Goryunova, Irina Grebenshchikova, Roman Ilchenko, Maria Ivannikova, Saule Karabalieva, Juliya Karpeeva, Elena Khaykina, Zhanna Kobalava, Irina Kononenko, Oxana Korolik, Anna Korshunova, Victor Kostenko, Irina Krasnopevtseva, Ludmila Krylova, Polina Kulkova, Irina Kuzmina, Alla Ledyaeva, Sergey Levashov, Natalia Lokhovinina, Vadim Lvov, Narine Martirosyan, Sergey Nedogoda, Rostislav Nilk, Yulia Osmolovskaya, Alexey Panov, Olga Paramonova, Ekaterina Pavlova, Elena Pekareva, Nina Petunina, Svetlana Ponamareva, Galina Reshedko, Alla Salasyuk, Malvina Sepkhanyan, Alexandr Serebrov, Olesya Shabelnikova, Andrey Skvortsov, Olga Smirnova, Oxana Spiridonova, Svetlana Strogova, Evgeny Taratukhin, Sergey Tereschenko, Lubov Trukhina, Olga Tsarkova, Vera Tsoma, Farid Tumarov, Natalya Tyan, Tatiana Tyurina, Svetlana Villevalde, Elena Yankovaya, Ludmila Zarutskaya, Elena Zenkova, Aysha Badat, Frederik Bester, Suzanne Blignaut, Dirk Blom, Susan Booysen, Warren Boyd, Brigitte Brice, Susan Brown, Lesley Burgess, Reina Cawood, Kathleen Coetzee, Hillet Conradie, Tanja Cronje, Douwe de Jong, Graham Ellis, Shaunagh Emanuel, Ingrid Engelbrecht, Sharne Foulkes, Done Fourie, Gilbert Gibson, Thirumani Govender, Sumayah Hansa, Allana Colleen Hemus, Firzana Hendricks, Marshall Heradien, Chantelle Holmgren, Zaheer Hoosain, Emile Horak, Johannes Howard, Ignatius Immink, E. Janari, Daksha Jivan, Karl Klusmann, Weik Labuschagne, Yen-yu Lai, Gulam Latiff, J. Lombaard, Hanlie Lottering, Ronel Meeding, Shirley Middlemost, Haroon Mitha, Ismail Mitha, Sandile Mkhwanazi, Rajendran Moodley, Almeri Murray, Dany Musungaie, Yasmin Osman, Kirsten Peacey, Larisha Pillay-Ramaya, Catharina Pretorius, Hans Prozesky, Mahomed Sarvan, E Scholtz, Attila Sebesteny, Bianca Skinner, Michael Skriker, M Smit, Anna-Marie Stapelberg, Nicolaas Swanepoel, Dorothea Urbach, Dina van Aswegen, Francois van Zyl, Louis Van Zyl, Esme Venter, Shahid Wadvalla, Jeffrey Wing, Karen Wolmarans, Cristina Abreu, Pilar Aguilà, Eva Aguilera, Nuria Alonso, Carmen Alvarez, Priscila Cajas, Jose Carlos Castro, Roger Codinachs, Jose Contreras, Maria Jose Coves, Carmen Fajardo, Juan Carlos Ferrer, Neus Font, Mar Garcia, Maria Apolonia Gil, Fernando Gomez, Lluis Alberto Gomez, Jose Gonzalbez, Jose Luis Griera, Luís Masmiquel, Didac Mauricio, Silvia Narejos Perez, Juana Ana Nicolau, Olga Noheda Contreras, Josefina Olivan, Josefina Olivares, Emilio Ortega, Silvia Pellitero, Salvador Pertusa, Ferran Rius, Irene Rodriguez, Carlos Sánchez-Juan, Dolores Santos, Berta Soldevila, David Subias, Manel Terns, Carlos Trescoli, Judith Vilaplana, Alicia Villanueva, Jaan Albo, Kjell Antus, Mattias Axelsson, Lisa Bergström, Emil Binsell-Gerdin, Kurt Boman, Fabian Botond, Annika Dotevall, Anna Graipe, C Jarnet, Jessica Kaminska, Anders Kempe, Michael Korhonen, Carina Linderfalk, Bo Liu, Karl Ljungstroem, Karl Ljungström, Lennart Malmqvist, Linda Mellbin, Thomas Mooe, Peter Nicol, Anders Norrby, Ake Ohlsson, Annika Rosengren, Jan Saaf, Staffan Salmonsson, Olof Strandberg, Karl-Axel Svensson, Bengt-Olov Tengmark, Georgios Tsatsaris, Anders Ulvenstam, Peter Vasko, Chwen-Tzuei Chang, Hsin-Mei Chang, Jung-Fu Chen, To-Pang Chen, Ming-Min Chung, Chia-Po Fu, Te-Lin Hsia, Shih-Che Hua, Ming-Chun Kuo, Chia-ln Lee, I-Te Lee, Kae-Woei Liang, Shih Yi Lin, Chieh-Hsiang Lu, Wen-Ya Ma, Dee Pei, Feng-Chih Shen, Ching-Chieh Su, Shuo-Wei Su, Tsai-Sung Tai, Wan-Ni Tsai, Yi-Ting Tsai, Shih-Chen Tung, Jun-Sing Wang, Hui-I Yu, Ahmed Al-Qaissi, Vijayaraman Arutchelvam, Stephen Atkin, Simon Au, Myint Myint Aye, Stephen Bain, Cristina Bejnariu, Patrick Bell, Deepak Bhatnagar, Rudy Bilous, Neil Black, Ursula Brennan, Barbara Brett, Jana Bujanova, Elaine Chow, Andrew Collier, Amanda Combe, Christopher Courtney, Hamish Courtney, James Crothers, Patrick Eavis, Jackie Elliott, Salvatore Febbraro, Jim Finlayson, Rajiv Gandhi, Sharon Gillings, Jonathan Hamling, Roy Harper, Tim Harris, Kahal Hassan, Simon Heller, Alison Jane, Zeeshan Javed, Tim Johnson, Stephen Jones, Adele Kennedy, David Kerr, Brian Kilgallon, Judith Konya, John Lindsay, Lina Lomova-Williams, Helen Looker, David MacFarlane, Sandra Macrury, Iqbal Malik, Rory McCrimmon, Douglas McKeith, John McKnight, Biswa Mishra, Racha Mukhtar, Ciara Mulligan, Maurice O'Kane, Tolu Olateju, Ian Orpen, Tristan Richardson, Desmond Rooney, Shorsha Bae Ross, Thozhukat Sathyapalan, Naveen Siddaramaiah, Lee Euan Sit, Jeffrey Stephens, Frances Turtle, Ammar Wakil, Emma Walkinshaw, Asem Ali, Robert Anderson, Richard Arakaki, Omar Aref, Mehrdad Kevin Ariani, David Arkin, Salomon Banarer, George Barchini, Arti Bhan, Kelley Branch, Donald Brautigam, Stephen Brietzke, Maridez Brinas, Yudit Brito, Casey Carter, Kimberely Casagni, Sabina Casula, Simon Chakko, Seth Charatz, Dale Childress, Lisa Chow, Malgorzata Chustecka, Subha Clarke, Lisa Cohen, Barry Collins, Gildred Colon Vega, Angel Comulada-Rivera, Gregorio Cortes-Maisonet, Matthew Davis, Jose de Souza, Cyrus Desouza, Mary Dinnan, Bobbi Duffy-Hidalgo, Barbara Dunn, Julia Dunn, Marshall Elman, James Felicetta, Stuart Finkelstein, David Fitz-Patrick, Hermes Florez, Alan Forker, Wayne Fowler, Sonja Fredrickson, Zachary Freedman, Brooke Gainey Narron, Kristin Gainey-Ferree, Michael Gardner, Christian Gastelum, Stephen Giddings, Eve Gillespie, Michael Paul Gimness, Gary Goldstein, Maria Gomes, Nelson Gomez, Timothy Gorman, Ketan Goswami, Arthur Graves, Scott Hacking, Charles Hall, Lenita Hanson, Sherman Harman, David Heber, Robert Henry, Janette Hiner, Irl Hirsch, Priscilla Hollander, Thomas Hooker, Barry Horowitz, Laura Hoste, Loli Huang, Minh Huynh, Dan Hyman, Soha Idriss, Ali Iranmanesh, Dennis Karounos, Moti Kashyap, Lois Katz, William Kaye, Yevgeniy Khaiton, Romesh Khardori, Timothy Kitchen, Andrew Klein, Wendi Knffem, Mikhail Kosiborod, Nicola Kreglinger, Davida Kruger, Anubhav Kumar, Ivan Laboy, Patricia Larrabee, Laura Larrick, Donna Lawson, Mike Ledet, James Lenhard, James Levy, George Li, Zhaoping Li, David Lieb, April Limcolioc, Jane Lions-Patterson, Daniel Lorber, Daniel Lorch, Michael Lorrello, Peter Lu, Kathryn Jean Lucas, Siu-Ling Ma, Michael MacAdams, Michelle Magee, Alexander Magno, Aparna Reddy Mahakala, Jennifer Marks, Anthony McCall, William McClanahan, Carole McClary, Lydia Melendez, John Melish, Deanna Michaud, Christopher Miller, Neil Miller, Pablo Mora, Marriyam Moten, Sunder Mudaliar, Gregory Myrick, Puneet Narayan, Mike Nassif, Karena Neri, Tabitha Newton, Patricia Niblack, Philip Nicol, Ebenezer Nyenwe, A. Ola Odugbesan, Yolanda Okorocha, Ramón Ortiz Carrasquillo, Kwame Osei, Coromoto Palermo, Hiren Patel, Krishna Patel, Cindy Pau, Michael Perley, Sanford Plevin, Elena Plummer, Richard Powell, Mohammed Qintar, Rex Rawls, John Reyes-Castano, Lillian Reynolds, Robert Richards, Julio Rosenstock, Caroline Rowe, Jahandar Saleh, Sony Sam, Alfredo Sanchez, Donald Sander, Bruce Sanderson, Virginia Savin, Elizabeth Seaquist, Jayendra Shah, Serena Shi, Vijay Shivaswamy, Tammi Shlotzhauer, David Shore, Bobbie Skukowski, Kyaw Soe, Vesna Solheim, Joseph Soufer, Helmut Steinberg, Jaime Steinsapir, Phillip Tarkington, Debra Thayer, Stephen Thomson, James Thrasher, Joseph Tibaldi, Jeff Tjaden, Oberto Tores, Dace Trence, Subbulaxmi Trikudanathan, Jagdeesh Ullal, Gabriel Uwaifo, Anthony Vo, Kenny Vu, Damandeep Walia, Karen Weiland, Fred Whitehouse, Thomas Wiegmann, Kathleen Wyne, Alan Wynne, Kevin Yuen, Joel Zaretzky, James Zebrack, Franklin Zieve, William Zigrang, and Everest

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Recombinant Fusion Proteins, Placebo-controlled study, Glucagon-Like Peptides, 030204 cardiovascular system & hematology, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Medicine, Albuminuria, Humans, Hypoglycemic Agents, Diabetic Nephropathies, 030212 general & internal medicine, Renal replacement therapy, Aged, Intention-to-treat analysis, business.industry, Hazard ratio, General Medicine, Middle Aged, medicine.disease, Immunoglobulin Fc Fragments, Diabetes Mellitus, Type 2, Creatinine, Dulaglutide, Female, business, medicine.drug, Kidney disease, Glomerular Filtration Rate
Abstract

Digital, Background: Two glucagon-like peptide-1 (GLP-1) receptor agonists reduced renal outcomes in people with type 2 diabetes at risk for cardiovascular disease. We assessed the long-term effect of the GLP-1 receptor agonist dulaglutide on renal outcomes in an exploratory analysis of the REWIND trial of the effect of dulaglutide on cardiovascular disease. Methods: REWIND was a multicentre, randomised, double-blind, placebo-controlled trial at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo and followed up at least every 6 months for outcomes. Urinary albumin-to-creatinine ratios (UACRs) and estimated glomerular filtration rates (eGFRs) were estimated from urine and serum values measured in local laboratories every 12 months. The primary outcome (first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes), secondary outcomes (including a composite microvascular outcome), and safety outcomes of this trial have been reported elsewhere. In this exploratory analysis, we investigate the renal component of the composite microvascular outcome, defined as the first occurrence of new macroalbuminuria (UACR >33·9 mg/mmol), a sustained decline in eGFR of 30% or more from baseline, or chronic renal replacement therapy. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01394952. Findings: Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). At baseline, 791 (7·9%) had macroalbuminuria and mean eGFR was 76·9 mL/min per 1·73 m2 (SD 22·7). During a median follow-up of 5·4 years (IQR 5·1-5·9) comprising 51 820 person-years, the renal outcome developed in 848 (17·1%) participants at an incidence rate of 3·5 per 100 person-years in the dulaglutide group and in 970 (19·6%) participants at an incidence rate of 4·1 per 100 person-years in the placebo group (hazard ratio [HR] 0·85, 95% CI 0·77-0·93; p=0·0004). The clearest effect was for new macroalbuminuria (HR 0·77, 95% CI 0·68-0·87; p, Ciencias Médicas y de la Salud

Published
2019

43. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial

Author

Hertzel C Gerstein, Helen M Colhoun, Gilles R Dagenais, Rafael Diaz, Mark Lakshmanan, Prem Pais, Jeffrey Probstfield, Jeffrey S Riesmeyer, Matthew C Riddle, Lars Rydén, Denis Xavier, Charles Messan Atisso, Leanne Dyal, Stephanie Hall, Purnima Rao-Melacini, Gloria Wong, Alvaro Avezum, Jan Basile, Namsik Chung, Ignacio Conget, William C Cushman, Edward Franek, Nicolae Hancu, Markolf Hanefeld, Shaun Holt, Petr Jansky, Matyas Keltai, Fernando Lanas, Lawrence A Leiter, Patricio Lopez-Jaramillo, Ernesto German Cardona Munoz, Valdis Pirags, Nana Pogosova, Peter J Raubenheimer, Jonathan E Shaw, Wayne H-H Sheu, Theodora Temelkova-Kurktschiev, Mercedes Abella, Andrea Alebuena, Sandra Almagro, Eduardo Amoroso, Paula Anadon, Elizabeth Andreu, Guillermo Aristimuño, Maria Arzadun, Maria Barbieri, Raul Barcudi, Ines Bartolacci, Gabriel Bolobanich, Anselmo Bordonava, Miguel Bustamante Labarta, Betina Bustos, Alberto Caccavo, Alejandra Camino, Maria Cantero, Maria Carignano, Luis Cartasegna, Marcela Cipullo, Víctor Commendatore, Victoria Conosciuto, Osvaldo Costamagna, Claudia Crespo, Jose Cuello, Carlos Cuneo, Sandra Cusimano, Sofia Dean, Claudio Dituro, Andrea Dominguez, Miguel Farah, Alberto Fernandez, Florencia Fernandez, Adriana Ferrari, Patricia Flammia, Jose Fuentealba, Karina Beatriz Gallardo, Celso Garcia, Ruben Garcia Duran, Marcelo Garrido, Rodolfo Gavicola, Claudio Gerbaudo, Graciela Gilli, Ana Paula Giotto, Pedro Godoy Bolzán, Oscar Gomez Vilamajo, Fernando Guerlloy, Cristian Guridi, Narcisa Gutierrez Garrido, Eduardo Hasbani, Sonia Hermida, Miguel Hominal, Adrian Hrabar, Adrián Ingaramo, Alejandra Izzicupo, Mario Krynski, Mariana Lagrutta, Paulina Lanchiotti, Maria Langhe, Veronica Leonard, Javier Llanos, Ricardo Lopez Santi, Jorge Lowenstein, Cecilia Luquez, Ignacio Mackinnon, Melina Mana, Sara Manzur, Javier Marino, Carolina Martella, Roger Martinez, Re Matias, Javier Matkovich, Monica Meritano, Oscar Montaña, María Mulazzi, Juan Ochoa, Gustavo Paterlini, María Pelagagge, Maria Elena Peralta Lopez, Aldo Prado, Lorena Pruyas, Martín Racca, Carola Ricotti, Carolina Rodriguez, Mariano Romero Vidomlansky, Ricardo Ronderos, Ana Laura Sadowski, Jorgelina Sala, Alejandro Sánchez, Andrea Santoro, Lilia Schiavi, Mariano Sein, Virginia Sernia, Leonardo Serra, Maximiliano Sicer, Tomas Smith, Leonardo Soso, Georgina Sposetti, Andrea Steinacher, Jorge Stival, Jorge Tedesco, Hugo Tonin, Mauro Tortolo, Maria Ulla, Julio Vallejos, Marisa Vico, Luciana Virgillito, Virginia Visco, Daniel Vogel, Florencia Waisman, César Zaidman, Noemi Zucchiatti, Imran Badshah, Neale Cohen, Peter Colman, David Colquhoun, Timothy Davis, Spiros Fourlanos, Greg Fulcher, Jane Hamlyn, Cilla Haywood, Samantha Hocking, Maeve Huchinson, William Jeffries, Mervyn Kyl, Clement Lo, PeakMann Mah, Ashley Makepeace, Dolly Marope, Natalie Nanayakkar, Alison Nankervis, Neil Palmer, Barbara Palolus, Satish Pillai, Sarah Price, Joseph Proietto, Anne Reutens, Natassia Rodrigo, Abdul Sheikh, Greg Smith, Michelle So, Georgia Soldatos, Bronwyn Stuckey, Priya Sumithran, Helena Teede, Parind Vora, Lyn Williams, Eduardo Abib, Christiani Adão Poço, Érica Ferreira Alves, Janaina Andreatta Bernardi Barea, Livia Avezum Oliveira, Denise Ludovico da Costa de Castro, Ivan Correa da Cruz, Midiã Costa, Ivan Cruz, Sidney Cunha, Marco Antonio Vieira Da Silva, Renata de Carvalho Camara Bona, Bruna de Paula, Freddy Eliaschewitz, Guilherme Fazolli, Carlos Alberto Ferreira Filho, Jose Fortes, Cesar França, Denise Reis Franco, Paulo Roberto Genestreti, Flavio Giorgeto, Rodrigo Marques Gonçalves, Michele Elka Grossman, Ana Claudia Henrique Marcelino, Mauro Hernandes, Ana Horta, Cristiano Jaeger, Midia Kaneblai, Cecilia Kauffman Rutenberg, Jose Francisco Kerr Saraiva, Maria Angelica Lemos, Lilia Maia, Euler Roberto Manenti, Mariana Marques, Cynthia Melissa Valerio, Rodrigo Moreira, Flávia Mothé, Osana Maria Mouco, Philip Moura, José Carlos Moura Jorge, Carlos Nakashima, Marcelo Nakazone, Thiago Napoli, Cristiane Nunes, Joao Eduardo Nunes Salles, Karla Oliveira, Marcela Oliveira, Gracielly de Souza Pantano, Fabio Petri, Leonardo Piazza, Andreia Carla Pires, Patricia Pizzato, Sergio Prata, Dalton Precoma, Rafael Rech, Gilmar Reis, Heleno Reis, Elisabete Resende, Jose Ribas Fortes, Sylka Rodovalho, Fabio Rossi dos Santos, Joao Eduardo Salles, Célia Regina Sampaio, Thiago Santos, Vanessa Santos dos Santos, Tulio Silva e Quadros, Daniel Silveira, Katia Nunes Siqueira, M Teireira, Marcelo Uehara, C Valerio, Henrique Vianna, Maria Helena Vidotti, Guilherme de Lima Visconti, Maria Teresa Zanella, Viktoriya Andreeva, Radoslav Borisov, Nikolay Botushanov, Georgi Dimitrov, Kameliya Dimova, Tsvetan Dragoychev, Valentina Grigorova, Valentina Gushterova, Ivaylo Ivanov, Tatyana Kocelova, Dimo Kurktschiev, Milena Miletieva, Neli Nenkova-Gugusheva, Ralitsa Pancheva, Maria Pavlova, Dimitar Raev, Vesela Spasova, Anastas Stoikov, Dimitar Troev, Todor Yanev, Mariana Yoncheva-Mihaylova, Alexander Abitbol, Buki Ajala, Abdullh Alguwaihes, Jean-Luc Ardilouze, Nahla Aris-Jilwan, Amel Arnaout, Ronnie Aronson, Nadeem Aslam, Sandra Babin, Jean-Patrice Bailargeon, Allan Bailey, Harpreet Bajaj, Christian Beauchesne, Sorin Beca, Andre Belanger, Alan Bell, Diego Bellabarba, Lori Berard, Brian Berenbaum, Vincent Bergeron, Joseph Berlingieri, Frédéric Bernier, Phoebe Bishara, David Blank, Ian Blumer, Suzanne Brault, Donald Breton, André Carpentier, James Cha, Prakash Chandra, Jean-Louis Chiasson, James R Conway, Ghyslaine Couture, Nathalie Couture, Gilles Dagenais, Dyotirmoy Datta, Giuseppe D'Ignazio, Richard Dumas, Didier Fay, Andre Frechette, Louise Frenette, Daisy Fung, Nathalie Gagnon, Meri Galter, Jean Garon, Jean Sebastien Gauthier, Christian Geadah, Jeremy Gilbert, Ronald Girard, Ronald Goldenberg, Loren David Grossman, Nikhil Gupta, Jean-Pierre Halle, Marie-France Hivert, Ghislaine Houde, Robyn Houlden, Irene Hramiak, Ted Jablonski, Akshay Jain Jain, Hasnain Khandwala, Munish Khosla, C Lachance, Emilie Laflamme, Marie-France Langlois, Luc Larivee, Joanne Liutkus, Heather Lochnan, Saleem Malik, Charlotte McDonald, Pravinsagar Mehta, John Mihailidis, Alain Milot, Priya Narula, Patrice Nault, Arun Nayar, William Nisker, Gilles Ouellet, Jean Palardy, Minta Patel, Terri Paul, Sue Pedersen, Patrice Perron, Marie-Hélène Pesant, Paul Poirier, Marie-Claude Poulin, Zubin Punthakee, Waheed Rehman, Stuart Ross, P Sagar, Nouhad Saliba, Sam Sandler, Alicia Schiffrin, Robert Schlosser, Anila Seth-Sharma, Mark Sherman, David Sionit, Tharsan Sivakumar, Juan Soto, Eric St-Amour, Oren Steen, Jack Sussman, Adam Telner, Sheldon Tobe, David-Yaw Twum-Barima, Audrey Van Zanten, Nicole VanRossum, Jonathan Vecchiarelli, Rick Ward, John Wessengel, Stanley Weisnagel, Igor Wilderman, Vincent Woo, Natalia Yakubovich, Jean-Francois Yale, Zeina Yared, Monica Acevedo, Maria Loreto Aguirre, Andres Aizman, Maria Soledad Barroso, Leonardo Cobos, Alfredo Danin Vargas, Barbara Descalzi, Gonzalo Godoy, Elio Grumberg, Rodolfo Lahsen, Gladys Larenas, Eugenia Ortiz, Javier Paredes, Sergio Potthoff, Eva Retamal, Luis Rojas, Manuel Salgado, Claudio Santibanez, Carmen Solis, Benjamin Stokins, Jose Accini, Javier Acebedo, Lina Maria Agudelo Baena, Soraya Alarcon, Juliana Angel, Edgar Arcos, M Aroca Martinez, Leonor Atuesta, Jose Balaguera, Doris Ballestas, Sandra Isabel Barrera, Rosmy Barrios Reyes, Adolfo Bayona, Andres Bermudez, Diego Zarate Bernal, Marco Blanquicett, Victor Bravo, Wendy Bueno, Alvaro Burbano Delgado, Alberto Cadena, Andres Cadena, Sandra Caicedo, Carlos Celemin, Ricardo Consuegra, Cristhian Contreras Pimienta, Kelly Johenis Corredor, Carlos Cure, Lizeth Dayana De La Hoz Rueda, Erika Delgado, Sarahy Diaz, Marta Diego, Anabell Donado, William Encinales Sanabria, Juliana Escobar, Gillian Escorcia, Leonardo Forero, Laura Fuentes, Maria Garcia, Henry Garcia Lozada, Luis Garcia Ortiz, Angela Giraldo, Laura Gomez Gonzalez, Javier Granada, Corina Gutierrez, Natalia Henao, Edwin Hernandez, Olga Maria Herrera Uejbe, Juan Diego Higuera Cobos, Jaime Ibarra Gómez, Edwin Hernandez Jaimes, Monica Jaramillo, Nicolas Jaramillo, Carlos Jaramillo Gomez, Monica Jaramillo Sanchez, Ivonne Jarava Durán, Catalina Lopez Ceballos, Claudia Madrid, Elias María Amastha, Jennifer Mercado, Dora Ines Molina, Jessica Molina Soto, Carlos Montoya, Alexander Morales, Carolina Muñoz, Luis Alejandro Orozco, Oscar Osorio, Jorge Mario Palmera Sanchez, Adwar Peña, Jose Perez, Juan Perez Agudelo, Germán Pérez Amador, Carlos Pertuz, Irina Posada, Carlos Puerta, Adalberto Quintero, Diana Quiroz, Carmen Rendon, Alberto Reyes, Alvaro Reyes, Diana Ripoll, Carlos Rivera, Maria Rocha, Jose F Rodriguez, Kervis Asid Rodriguez Villanueva, Javier Emilio Rodriguez Zabala, Sindy Rojas, Maria Romero, Ricardo Rosero, Angelica Rocio Rosillo Cardenas, Lina Rueda, Gregorio Sanchez, Tatiana Sanchez, Arístides Sotomayor Herazo, Monica Suarez, Mariana Torres, Freddy Trujillo, Miguel Urina, Lazaro Van Strahlen, Carlos Velandia, Carolina Velasquez Guzman, Elizabeth Velazquez, Tatiana Vidal Prada, Juan Pablo Yepez Alvaran, Diego Zarate, Jana Andelova, Radka Benesova, Barbara Buzova, Vladimir Cech, Ida Chodova, Miroslav Choura, Antonin Dufka, Andrea Gamova, Jakub Gorgol, Tomas Hala, Hana Havlova, Dagmar Hlavkova, Petra Horanska, Juliana Ilcisin-Valova, Petra Jenickova, Ondrej Jerabek, Ilona Kantorova, Katerina Kolomaznikova, Iva Kopeckova, Miroslava Kopeckova, Karel Linhart, Tomas Linhart, Jan Malecha, Emilia Malicherova, Dana Neubauerova, Martina Oznerova, Radan Partys, Eva Pederzoliova, Maria Petrusova, Vera Prymkova, Eva Racicka, Ida Reissova, Eva Roderova, Libor Stanek, Alena Striova, Dana Svarcova, Petr Svoboda, Emilia Szeghy Malicharova, Jan Urge, Ladislav Vesely, Bedich Wasserburger, Hilde Wasserburgerova, Emil Zahumensky, Vaclav Zamrazil, Hasan Alawi, Ernestos Anastasiadis, Elisabeth Axthelm, Tasso Bieler, Christina Buhrig, Elizaveta Degtyareva, Frank Dellanna, Karl-Michael Derwahl, Stephan Diessel, Barbara Dogiami, Kirsten Dorn-Weitzel, Monika Ernst, Grit Faulmann, Baerbel Fetscher, Thomas Forst, Gabriele Freyer-Lahres, Klaus Funke, Xenia Ganz, Christiane Gleixner, Christoph Hanefeld, Sven Heinrichs, Stephanie Helleberg, Elena Henkel, Gerd Ruediger Hetzel, Caren Hoffmann, Frohmut Jacob, Stephan Jacob, Franziska John, Antonius Jonczyk, Wolfram Kamke, Christiane Klein, Martina Kleinhardt, Werner Kleophas, Christine Kosch, Kristin Kreutzmann, Achim Kühn, Young Hee Lee-Barkey, Alexander Lier, Sarah Maatouk, Joachim Minnich, Michael Mitry, Ilona Muessig, Diana Nicula, Martina Niemann, Joerg Nothroff, Petra Ott, Andreas Pfuetzner, Andreas Pfützner, Frank Pistrosch, Wildgard Pohl, Zdenka Prochazkova, Marlena Retkowska, Heiko Rosin, Daniela Sachsenheimer, Holger Samer, Mazin Sanuri, Axel Schaefer, Frank Schaper, Erik-Delf Schulze, Marita Schulze, Martina Schumann, Thomas Segiet, Veronika Sowa, Hans-Detlev Stahl, Franziska Steinfeldt, Madlen Teige, Bjoern Trieb, Diethelm Tschoepe, Peter Uebel, Bernd Warken, Ingo Weigmann, Klaus Weyland, Klara Wilhelm, Timea Balo, Miklos Balsay, Ilona Bende, Katalin Bezzegh, Zita Birkus, Barbara Buday, Melinda Csomai, Laszlo Deak, Eniko Dezso, Peter Faludi, M Faluvegi, Ilona Fazekas, Agota Feher, Csaba Fejer, Ervin Finta, Agnes Fulcz, Zsolt Gaal, Mihaly Gurzo, Krisztina Hati, Gabriella Herczeg, Ildiko Jozsef, Marta Juhasz, Katalin Keltai, Laszlo Koranyi, Eniko Kulcsar, Krisztina Kun, Andrea Laczko, Botond Literáti-Nagy, Izabella Mezo, Margit Mileder, I Moricz, Károly Nagy, Bela Nagybaczoni, Csaba Nemeth, Agnes Oze, Jozsef Pauer, Eva Peterfai, Bela Polocsanyi, Ferenc Poor, István Reiber, Csaba Salamon, Julia Sebestyen, Ildiko Torok, Marianna Tuu, Andrea Varga, Viktor Vass, Chul Min Ahn, Chulwoo Ahn, Park ByungWon, Hyuk-Jae Chang, Kiyuk Chang, Eui-Young Choi, Han Seok Choi, Jin-Wook Chung, Bum- Kee Hong, Young Joon Hong, Min Su Hyon, Myung Ho Jeong, Shinae Kang, Byeong-Keuk Kim, Ji-Hyun Kim, Ju Han Kim, Kee-Sik Kim, Moo Hyun Kim, Pum-Joon Kim, Soon-Kil Kim, Yong-Seok Kim, Young Kwon Kim, Yoon Seok Koh, Hyuck Moon Kwon, Byoung Kwon Lee, Byung-Wan Lee, Jin Bae Lee, Myoung-Mook Lee, Young-Mee Lim, Pil Ki Min, Jong Sung Park, Jongsuk Park, Keun Ho Park, Sungha Park, Wook Bum Pyun, Se Joong Rim, Dong-Ryeol Ryu, Hong-Seog Seo, Ki Bae Seung, Dong-Ho Shin, Doo Sun Sim, Young Won Yoon, Ilze Andersone, Kristine Babicka, Inga Balcere, Roberts Barons, Inguna Capkovska, Kristine Geldnere, Inese Grigane, Baiba Jegere, Ilze Lagzdina, Lija Mora, Sigita Pastare, Rota Ritenberga, Janina Romanova, Inta Saknite, Natalja Sidlovska, Jelena Sokolova, Sandra Steina, Iveta Strizko, Dace Teterovska, Brigita Vizina, Lina Barsiene, Gintare Belozariene, Laura Daugintyte-Petrusiene, Nijole Drungiliene, Nijole Garsviene, Ala Grigiene, Vytautas Grizas, Virginija Jociene, Dalia Kalvaitiene, Jugeta Kaupiene, Jurate Kavaliauskiene, Dalia Kozloviene, Ilona Lapteva, Birute Maneikiene, Jolanta Marcinkeviciene, Vaidilija Markauskiene, Salomeja Meiluniene, Almantas Norkus, Rita Norviliene, Vladimiras Petrenko, Ruta Radzeviciene, Gintare Sakalyte, Gediminas Urbonas, Skaiste Urbutiene, Donatas Vasiliauskas, Dzilda Velickiene, Carlos Aguilar, Marco Alcocer, Juan Antonio Avalos-Ramirez, Ramiro Banda-Elizondo, Rubria Bricio-Ramirez, Karla Cardenas Mejia, Francisco Cavazos, Jesus Chapa, Erika Cienfuegos, Astrid De la Peña, Gilberto de la Peña Topete, Manuel Odin De los Rios Ibarra, Daniel Elias, Claudia Flores-Moreno, Pedro Garcia Hernandez, Luis Gerardo Gonzalez, Rosa Linda Guerra Moya, Arturo Guerra-Lopez, Raymundo Hernandez Baylon, Carolina Herrera Colorado, Marisol Herrera-Marmolejo, Neri Islas-Palacios, Esteban Lopez, Fernando Lopez, Agustin Lopez Alvarado, Rosa Isela Luna Ceballos, Enrique Morales Villegas, Gualberto Moreno-Virgen, Rosa Linda Parra Perez, Sara Pascoe Gonzalez, Irving Peralta-Cantu, Roopa Previn, Rosa Ramirez, Rubria Ramirez, Maria Guadalupe Ramos Zavala, Monica Rodriguez, Rocio Salgado-Sedano, Ana Claudia Sanchez-Aguilar, Edith Santa Rosa Franco, Leobardo Sauque-Reyna, Rodrigo Suarez Otero, Ivonne Torres, Enrique Velarde-Harnandez, Juan Villagordoa, Efrain Villeda-Espinoza, Jorge Vital-Lopez, Cristian Jair Zavala- Bello, John Baker, Elaine Barrington-Ward, Thomas Brownless, Richard Carroll, Simon Carson, Michelle Choe, Andrew Corin, Brian Corley, Richard Cutfield, Neelam Dalaman, Paul Dixon, Paul Drury, Keith Dyson, Chris Florkowski, Monica Ford, William Frengley, Colin Helm, Colin Katzen, Jane Kerr, Manish Khanolkar, David Kim, Renata Koops, Jeremy Krebs, Robert Leikis, Kwan Low, Alison Luckey, Richard Luke, Susan Macaulay, Rodney Marks, Catherine McNamara, Dean Millar-Coote, Steven Miller, Naomi Mottershead, James Reid, Narcisa Robertson, Ian Rosen, David Rowe, Ole Schmiedel, Russell Scott, Jeffrey Sebastian, Davitt Sheahan, Victoria Stiebel, Ian Ternouth, Chris Tofield, Dirk Venter, Michael Williams, Miles Williams, Fiona Wu, Simon Young, Malgorzata Arciszewska, Anna Bochenek, Piotr Borkowski, Przemyslaw Borowy, Tomasz Chrzanowski, Edward Czerwinski, Marek Dwojak, Agnieszka Grodzicka, Izabela Janiec, Joanna Jaruga, Ewa Krystyna Jazwinska-Tarnawska, Krystyna Jedynasty, Danuta Juzwiak-Czapiewska, Jadwiga Karczewicz-Janowska, Jan Konieczny, Marek Konieczny, Marek Korol, Maciej Kozina, Ewa Krzyzagorska, Ewa Kucharczyk-Petryka, Roman Laz, Anna Majchrzak, Zdzislawa Mrozowska, Michal Mularczyk, Elzbieta Nowacka, Jadwiga Peczynska, Robert Petryka, Radoslaw Pietrzak, Dorota Pisarczyk-Wiza, Aleksandra Rozanska, Zofia Ruzga, Emilia Rzeszotarska, Malgorzata Sacha, Marzenna Sekulska, Anna Sidorowicz-Bialynicka, Teresa Stasinska, Agnieszka Strzelecka-Sosik, Teresa Swierszcz, Katarzyna Miroslawa Szymkowiak, Olga Turowska, Krystyna Wisniewska, Maciej Wiza, Iwona Wozniak, Katarzyna Zelazowska, Bernadetta Ziolkowska-Gawron, Danuta Zytkiewicz-Jaruga, Adrian Albota, Carmina Alexandru, Rodica Avram, Cornelia Bala, Diana Barbonta, Roxana Barbu, Daniela Braicu, Nicoleta Calutiu, Doina Catrinoiu, Anca Cerghizan, Alina Ciorba, Anca Craciun, Rodica Doros, Livia Duma, Ancuta Dumitrache, Ioana Ferariu, Anca Ferician Moza, Alexandrina Ghergan, Gheorghe Ghise, Mariana Graur, Mihaela Gribovschi, Bogdan Mihai, Laura Mihalache, Madalina Mihalcea, Nicoleta Mindrescu, Magdalena Morosanu, Andrea Morosoanu, Maria Mota, Anca Moza, Valerica Nafornita, Narcisa Natea, Simona Nicodim, Cristina Nita, Adriana Onaca, Mircea Onaca, Cristina Pop, Lavinia Pop, Amorin Popa, Alexandrina Popescu, Luchiana Pruna, Gabriela Roman, Mihaela Rosu, Alexandra Sima, Doina Sipciu, Carmen Narcisa Sitterli-Natea, Iosif Szilagyi, Minodora Tapurica, Adrian Tase, Adriana-Carmen Tutescu, Luminita Vanghelie, Ioana Verde, Adrian Vlad, Mihaela Zarnescu, Roman Akhmetov, Irina Allenova, Irina Avdeeva, Oksana Baturina, Irina Biserova, Nikolay Bokovin, Irina Bondar, Natalia Burova, Galina Chufeneva, Elena Chumachek, Marina Demidova, Alexander Demin, Vera Drobysheva, Irina Egorova, Lev Esenyan, Ekaterina Gelig, Sergey Gilyarevsky, Maria Golshmid, Arseniy Goncharov, Anastasia Gorbunova, Ivan Gordeev, Vera Gorelysheva, Tatiana Goryunova, Irina Grebenshchikova, Roman Ilchenko, Maria Ivannikova, Saule Karabalieva, Juliya Karpeeva, Elena Khaykina, Zhanna Kobalava, Irina Kononenko, Oxana Korolik, Anna Korshunova, Victor Kostenko, Irina Krasnopevtseva, Ludmila Krylova, Polina Kulkova, Irina Kuzmina, Alla Ledyaeva, Sergey Levashov, Natalia Lokhovinina, Vadim Lvov, Narine Martirosyan, Sergey Nedogoda, Rostislav Nilk, Yulia Osmolovskaya, Alexey Panov, Olga Paramonova, Ekaterina Pavlova, Elena Pekareva, Nina Petunina, Svetlana Ponamareva, Galina Reshedko, Alla Salasyuk, Malvina Sepkhanyan, Alexandr Serebrov, Olesya Shabelnikova, Andrey Skvortsov, Olga Smirnova, Oxana Spiridonova, Svetlana Strogova, Evgeny Taratukhin, Sergey Tereschenko, Lubov Trukhina, Olga Tsarkova, Vera Tsoma, Farid Tumarov, Natalya Tyan, Tatiana Tyurina, Svetlana Villevalde, Elena Yankovaya, Ludmila Zarutskaya, Elena Zenkova, Aysha Badat, Frederik Bester, Suzanne Blignaut, Dirk Blom, Susan Booysen, Warren Boyd, Brigitte Brice, Susan Brown, Lesley Burgess, Reina Cawood, Kathleen Coetzee, Hillet Conradie, Tanja Cronje, Douwe de Jong, Graham Ellis, Shaunagh Emanuel, Ingrid Engelbrecht, Sharne Foulkes, Done Fourie, Gilbert Gibson, Thirumani Govender, Sumayah Hansa, Allana Colleen Hemus, Firzana Hendricks, Marshall Heradien, Chantelle Holmgren, Zaheer Hoosain, Emile Horak, Johannes Howard, Ignatius Immink, E. Janari, Daksha Jivan, Karl Klusmann, Weik Labuschagne, Yen-yu Lai, Gulam Latiff, J. Lombaard, Hanlie Lottering, Ronel Meeding, Shirley Middlemost, Haroon Mitha, Ismail Mitha, Sandile Mkhwanazi, Rajendran Moodley, Almeri Murray, Dany Musungaie, Yasmin Osman, Kirsten Peacey, Larisha Pillay-Ramaya, Catharina Pretorius, Hans Prozesky, Mahomed Sarvan, E Scholtz, Attila Sebesteny, Bianca Skinner, Michael Skriker, M Smit, Anna-Marie Stapelberg, Nicolaas Swanepoel, Dorothea Urbach, Dina van Aswegen, Francois van Zyl, Louis Van Zyl, Esme Venter, Shahid Wadvalla, Jeffrey Wing, Karen Wolmarans, Cristina Abreu, Pilar Aguilà, Eva Aguilera, Nuria Alonso, Carmen Alvarez, Priscila Cajas, Jose Carlos Castro, Roger Codinachs, Jose Contreras, Maria Jose Coves, Carmen Fajardo, Juan Carlos Ferrer, Neus Font, Mar Garcia, Maria Apolonia Gil, Fernando Gomez, Lluis Alberto Gomez, Jose Gonzalbez, Jose Luis Griera, Luís Masmiquel, Didac Mauricio, Silvia Narejos Perez, Juana Ana Nicolau, Olga Noheda Contreras, Josefina Olivan, Josefina Olivares, Emilio Ortega, Silvia Pellitero, Salvador Pertusa, Ferran Rius, Irene Rodriguez, Carlos Sánchez-Juan, Dolores Santos, Berta Soldevila, David Subias, Manel Terns, Carlos Trescoli, Judith Vilaplana, Alicia Villanueva, Jaan Albo, Kjell Antus, Mattias Axelsson, Lisa Bergström, Emil Binsell-Gerdin, Kurt Boman, Fabian Botond, Annika Dotevall, Anna Graipe, C Jarnet, Jessica Kaminska, Anders Kempe, Michael Korhonen, Carina Linderfalk, Bo Liu, Karl Ljungstroem, Karl Ljungström, Lennart Malmqvist, Linda Mellbin, Thomas Mooe, Peter Nicol, Anders Norrby, Ake Ohlsson, Annika Rosengren, Jan Saaf, Staffan Salmonsson, Olof Strandberg, Karl-Axel Svensson, Bengt-Olov Tengmark, Georgios Tsatsaris, Anders Ulvenstam, Peter Vasko, Chwen-Tzuei Chang, Hsin-Mei Chang, Jung-Fu Chen, To-Pang Chen, Ming-Min Chung, Chia-Po Fu, Te-Lin Hsia, Shih-Che Hua, Ming-Chun Kuo, Chia-ln Lee, I-Te Lee, Kae-Woei Liang, Shih Yi Lin, Chieh-Hsiang Lu, Wen-Ya Ma, Dee Pei, Feng-Chih Shen, Ching-Chieh Su, Shuo-Wei Su, Tsai-Sung Tai, Wan-Ni Tsai, Yi-Ting Tsai, Shih-Chen Tung, Jun-Sing Wang, Hui-I Yu, Ahmed Al-Qaissi, Vijayaraman Arutchelvam, Stephen Atkin, Simon Au, Myint Myint Aye, Stephen Bain, Cristina Bejnariu, Patrick Bell, Deepak Bhatnagar, Rudy Bilous, Neil Black, Ursula Brennan, Barbara Brett, Jana Bujanova, Elaine Chow, Andrew Collier, Amanda Combe, Christopher Courtney, Hamish Courtney, James Crothers, Patrick Eavis, Jackie Elliott, Salvatore Febbraro, Jim Finlayson, Rajiv Gandhi, Sharon Gillings, Jonathan Hamling, Roy Harper, Tim Harris, Kahal Hassan, Simon Heller, Alison Jane, Zeeshan Javed, Tim Johnson, Stephen Jones, Adele Kennedy, David Kerr, Brian Kilgallon, Judith Konya, John Lindsay, Lina Lomova-Williams, Helen Looker, David MacFarlane, Sandra Macrury, Iqbal Malik, Rory McCrimmon, Douglas McKeith, John McKnight, Biswa Mishra, Racha Mukhtar, Ciara Mulligan, Maurice O'Kane, Tolu Olateju, Ian Orpen, Tristan Richardson, Desmond Rooney, Shorsha Bae Ross, Thozhukat Sathyapalan, Naveen Siddaramaiah, Lee Euan Sit, Jeffrey Stephens, Frances Turtle, Ammar Wakil, Emma Walkinshaw, Asem Ali, Robert Anderson, Richard Arakaki, Omar Aref, Mehrdad Kevin Ariani, David Arkin, Salomon Banarer, George Barchini, Arti Bhan, Kelley Branch, Donald Brautigam, Stephen Brietzke, Maridez Brinas, Yudit Brito, Casey Carter, Kimberely Casagni, Sabina Casula, Simon Chakko, Seth Charatz, Dale Childress, Lisa Chow, Malgorzata Chustecka, Subha Clarke, Lisa Cohen, Barry Collins, Gildred Colon Vega, Angel Comulada-Rivera, Gregorio Cortes-Maisonet, Matthew Davis, Jose de Souza, Cyrus Desouza, Mary Dinnan, Bobbi Duffy-Hidalgo, Barbara Dunn, Julia Dunn, Marshall Elman, James Felicetta, Stuart Finkelstein, David Fitz-Patrick, Hermes Florez, Alan Forker, Wayne Fowler, Sonja Fredrickson, Zachary Freedman, Brooke Gainey Narron, Kristin Gainey-Ferree, Michael Gardner, Christian Gastelum, Stephen Giddings, Eve Gillespie, Michael Paul Gimness, Gary Goldstein, Maria Gomes, Nelson Gomez, Timothy Gorman, Ketan Goswami, Arthur Graves, Scott Hacking, Charles Hall, Lenita Hanson, Sherman Harman, David Heber, Robert Henry, Janette Hiner, Irl Hirsch, Priscilla Hollander, Thomas Hooker, Barry Horowitz, Laura Hoste, Loli Huang, Minh Huynh, Dan Hyman, Soha Idriss, Ali Iranmanesh, Dennis Karounos, Moti Kashyap, Lois Katz, William Kaye, Yevgeniy Khaiton, Romesh Khardori, Timothy Kitchen, Andrew Klein, Wendi Knffem, Mikhail Kosiborod, Nicola Kreglinger, Davida Kruger, Anubhav Kumar, Ivan Laboy, Patricia Larrabee, Laura Larrick, Donna Lawson, Mike Ledet, James Lenhard, James Levy, George Li, Zhaoping Li, David Lieb, April Limcolioc, Jane Lions-Patterson, Daniel Lorber, Daniel Lorch, Michael Lorrello, Peter Lu, Kathryn Jean Lucas, Siu-Ling Ma, Michael MacAdams, Michelle Magee, Alexander Magno, Aparna Reddy Mahakala, Jennifer Marks, Anthony McCall, William McClanahan, Carole McClary, Lydia Melendez, John Melish, Deanna Michaud, Christopher Miller, Neil Miller, Pablo Mora, Marriyam Moten, Sunder Mudaliar, Gregory Myrick, Puneet Narayan, Mike Nassif, Karena Neri, Tabitha Newton, Patricia Niblack, Philip Nicol, Ebenezer Nyenwe, A. Ola Odugbesan, Yolanda Okorocha, Ramón Ortiz Carrasquillo, Kwame Osei, Coromoto Palermo, Hiren Patel, Krishna Patel, Cindy Pau, Michael Perley, Sanford Plevin, Elena Plummer, Richard Powell, Mohammed Qintar, Rex Rawls, John Reyes-Castano, Lillian Reynolds, Robert Richards, Julio Rosenstock, Caroline Rowe, Jahandar Saleh, Sony Sam, Alfredo Sanchez, Donald Sander, Bruce Sanderson, Virginia Savin, Elizabeth Seaquist, Jayendra Shah, Serena Shi, Vijay Shivaswamy, Tammi Shlotzhauer, David Shore, Bobbie Skukowski, Kyaw Soe, Vesna Solheim, Joseph Soufer, Helmut Steinberg, Jaime Steinsapir, Phillip Tarkington, Debra Thayer, Stephen Thomson, James Thrasher, Joseph Tibaldi, Jeff Tjaden, Oberto Tores, Dace Trence, Subbulaxmi Trikudanathan, Jagdeesh Ullal, Gabriel Uwaifo, Anthony Vo, Kenny Vu, Damandeep Walia, Karen Weiland, Fred Whitehouse, Thomas Wiegmann, Kathleen Wyne, Alan Wynne, Kevin Yuen, Joel Zaretzky, James Zebrack, Franklin Zieve, William Zigrang, and Everest

Subjects
Male, medicine.medical_specialty, Recombinant Fusion Proteins, Population, Placebo-controlled study, Glucagon-Like Peptides, Myocardial Infarction, Type 2 diabetes, 030204 cardiovascular system & hematology, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, medicine, Humans, Hypoglycemic Agents, 030212 general & internal medicine, education, Aged, education.field_of_study, business.industry, Semaglutide, Hazard ratio, General Medicine, Middle Aged, medicine.disease, Immunoglobulin Fc Fragments, Stroke, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Dulaglutide, Female, business, medicine.drug
Abstract

Digital, Background Three different glucagon-like peptide-1 (GLP-1) receptor agonists reduce cardiovascular outcomes in people with type 2 diabetes at high cardiovascular risk with high glycated haemoglobin A1c (HbA1c) concentrations. We assessed the effect of the GLP-1 receptor agonist dulaglutide on major adverse cardiovascular events when added to the existing antihyperglycaemic regimens of individuals with type 2 diabetes with and without previous cardiovascular disease and a wide range of glycaemic control. Methods This multicentre, randomised, double-blind, placebo-controlled trial was done at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo. Randomisation was done by a computer-generated random code with stratification by site. All investigators and participants were masked to treatment assignment. Participants were followed up at least every 6 months for incident cardiovascular and other serious clinical outcomes. The primary outcome was the first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes), which was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01394952. Findings Between Aug 18, 2011, and Aug 14, 2013, 9901 participants (mean age 66·2 years [SD 6·5], median HbA1c 7·2% [IQR 6·6–8·1], 4589 [46·3%] women) were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). During a median follow-up of 5·4 years (IQR 5·1–5·9), the primary composite outcome occurred in 594 (12·0%) participants at an incidence rate of 2·4 per 100 person-years in the dulaglutide group and in 663 (13·4%) participants at an incidence rate of 2·7 per 100 person-years in the placebo group (hazard ratio [HR] 0·88, 95% CI 0·79–0·99; p=0·026). All-cause mortality did not differ between groups (536 [10·8%] in the dulaglutide group vs 592 [12·0%] in the placebo group; HR 0·90, 95% CI 0·80–1·01; p=0·067). 2347 (47·4%) participants assigned to dulaglutide reported a gastrointestinal adverse event during follow-up compared with 1687 (34·1%) participants assigned to placebo (p, Ciencias Médicas y de la Salud

Published
2019

45. Design and Baseline Characteristics of the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease Trial

Author

Abdulbaki Kumbasar, Pieter Gillard, Miguel Urina, Oner Ozdogan, Jonathan Barratt, Erik Penne, Ru San Tan, Carlos Eduardo Poli de Figueiredo, Bertrand Cariou, Trine Elisabeth Finnes, Sofia Malyutina, Andreas Kistler, Ciprian Constantin, Ruslan Sardinov, Dominique Guerrot, Goos Laverman, Jingmei Li, Alessia Fornoni, Konstantin Nikolaev, Gunnar Gislason, Asad Bhorat, Idalina Beirão, Markus Van der Giet, Nataliia Pashkovska, Ilona Kurnatowska, Ivan Vyshnyvetskyy, Mario Cozzolino, Maria Isabel Troya, Gillard, Pieter, Bakris, G, Agarwal, R, Anker, S, Pitt, B, Ruilope, L, Nowack, C, Kolkhof, P, Ferreira, A, Schloemer, P, Filippatos, G, and Trevisan, R

Subjects
Male, Hyperkalemia, Enfermedad cardiovascular, 030232 urology & nephrology, Type 2 diabetes, BAY 94-8862, 030204 cardiovascular system & hematology, urologic and male genital diseases, Diabete, Kidney, Aparato circulatorio, Azúcar, DOUBLE-BLIND, 0302 clinical medicine, Medicine, Diabetic Nephropathies, 610 Medicine & health, Aldosterone, Mineralocorticoid Receptor Antagonists, Outcome, Diabetes, Middle Aged, Urology & Nephrology, SPIRONOLACTONE, Treatment Outcome, medicine.anatomical_structure, Mineralocorticoid, Research Design, Nephrology, Disease Progression, HEART-FAILURE, Female, medicine.symptom, Life Sciences & Biomedicine, Glomerular Filtration Rate, medicine.medical_specialty, Finerenone, ALBUMINURIA, NEPHROPATHY, Urinary system, Urology, Outcomes, 03 medical and health sciences, Clinical, Double-Blind Method, Diabetes mellitus, Albuminuria, Humans, Naphthyridines, Aged, ANTAGONIST, Sistema cardiovascular, Patient-Oriented, Translational Research: Research Article, Science & Technology, business.industry, MORTALITY, medicine.disease, Kidney, Mineralocorticoid, Outcomes, Aldosterone, Diabetes Mellitus, Type 2, Kidney Failure, Chronic, MINERALOCORTICOID RECEPTOR, business, ALDOSTERONE BLOCKADE, Kidney disease
Abstract

Background: Among diabetics, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality, and progression of their underlying disease. Finerenone is a novel, non-steroidal, selective mineralocorticoid-receptor antagonist which has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD), while revealing only a low risk of hyperkalemia. However, the effect of finerenone on renal and CV outcomes has not been investigated in long-term trials yet. Methods: The Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease ­(FIDELIO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important renal and CV outcomes in T2D patients with CKD. FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 5.5 years. FIDELIO-DKD randomized 5,734 patients with an estimated glomerular filtration rate (eGFR) ≥25–2 and albuminuria (urinary albumin-to-creatinine ratio ≥30–≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death. Conclusion: FIDELIO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of renal and CV events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen.

Published
2019
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46. Characterization of a Group of Research Ethics Committees in Colombia

Author

Miguel Urina, Mónica Viteri, Humberto Reynales, Jairo Camacho, and Fernando Suárez-Obando

Subjects
Control (management), pesquisa, Certification, Comités de ética en investigación, Public administration, 0603 philosophy, ethics and religion, Ethical standards, 03 medical and health sciences, 0302 clinical medicine, comissão de ética em pesquisa, Political science, Research Ethics Committees, clinical protocols, 030212 general & internal medicine, comités de ética en invetigación, Pharmaceutical industry, Research ethics, protocolos clínicos, research, business.industry, General Engineering, Ethics committee, 06 humanities and the arts, revisión ética, Clinical trial, investigación, revisão ética, ethical review, 060301 applied ethics, business
Abstract

Resumen En las últimas décadas, los ensayos clínicos controlados patrocinados por la industria farmacéutica han aumentado de manera considerable, lo cual ha llevado a que sea necesario un mayor control y acompañamiento por parte de las entidades reguladoras, y de los comités de ética, para garantizar el adecuado cumplimiento de las normas éticas establecidas y de las buenas prácticas clínicas en general. En Colombia, el Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima), la entidad reguladora en el país, reglamenta y vigila el funcionamiento de la investigación clínica con medicamentos. En el 2008, esta entidad emitió la Resolución 2378, normatividad bajo la cual se establecen y regulan los diferentes actores de la investigación en Colombia, incluidos los comités de ética. Después de varios años de vigencia de esta norma, es necesario conocer si los comités de ética en investigación en Colombia funcionan de acuerdo con esta normativa, y determinar el estado de la implementación de lo solicitado en la regulación. Con este objetivo se diseñó una encuesta para ser respondida en forma voluntaria y se obtuvo respuesta de 25 de los 69 comités certificados en Colombia. El análisis fue posible en 22 de ellos cuya información estaba completa. En comparación con estudios anteriores, se observaron cambios favorables en el desarrollo y la organización de acuerdo con la norma actual propuesta. Abstract In the last decades, controlled clinical trials sponsored by the pharmaceutical industry have increased considerably. This has led to the need for greater control and assistance by regulators and ethics committees to ensure appropriate compliance with established ethical standards and good clinical practices in general. In Colombia, the National Food and Drug Surveillance Institute (INVIMA), the regulator in the country, controls and monitors the operation of clinical research with drugs. In 2008, this entity issued Resolution 2378, which provides and regulates research actors in Colombia, including ethics committees. After being in force for several years, it is necessary to know whether research ethics committees in Colombia operate in accordance with this regulation and to determine the status of implementation of the requirements therein. For this purpose, a survey was designed to be voluntarily answered and a response was obtained from 25 of the 69 certified committees in Colombia. Twenty-two of them could be analyzed because their information was complete. Compared with previous studies, favorable changes in development and organization were observed in accordance with the current proposed regulation. Resumo Nas últimas décadas, os ensaios clínicos controlados patrocinados pela indústria farmacêutica aumentaram consideravelmente, o que levou à necessidade de um maior controle e acompanhamento por entidades reguladoras e comitês de ética, para garantir o cumprimento adequado de normas éticas estabelecidas e boas práticas clínicas em geral. Na Colômbia, o Instituto Nacional de Vigilância de Medicamentos e Alimentos (Invima, na sigla em espanhol), órgão regulador no país, regulamenta e monitora o funcionamento da pesquisa clínica com medicamentos. Em 2008, essa entidade emitiu a Resolução 2378, que estabelece e regulamenta os diferentes atores da pesquisa na Colômbia, incluindo os comitês de ética. Depois de vários anos de vigência dessa norma, é necessário saber se os comitês de ética em pesquisa da Colômbia trabalham de acordo com este regulamento e determinar o estado da implementação do que é solicitado no regulamento. Com esse objetivo, uma pesquisa foi elaborada para ser respondida voluntariamente e uma resposta foi obtida de 25 dos 69 comitês certificados na Colômbia. A análise foi possível em 22 deles, cuja informação estava completa. Em comparação com estudos anteriores, mudanças favoráveis no desenvolvimento e organização foram observadas de acordo com a norma atual proposta.

Published
2018
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47. Cardiovascular and Other Outcomes Postintervention With Insulin Glargine and Omega-3 Fatty Acids (ORIGINALE)

Author

Jose Antônio Marin-Neto, Jeanne Clark, Alfredo Ramirez, Philip Böhme, Victor Gurevich, Miguel Urina, Valdis Pirags, Heather Lochnan, Jan Cornel, Bu Yeap, Ricardo Bohorquez, Marina F Kalashnikova, Aldo Pietro Maggioni, ALVARO AVEZUM, Igor Bondarenko, Monica Acevedo, Francesco Cacciatore, Weiping Jia, B. L. Gregoire Nyomba, Neslihan Bascil Tutuncu, Anastasia F Hutchinson, Sudeep K, Moti Kashyap, Adrian Vlad, Aivars Lejnieks, Jeong-Taek Woo, Shirley Jansen, Cristina Facanha, Laura Bryan, Louise Bordeleau, Patricio Lopez-Jaramillo, Adriana Forti, Flavia Lucia Lombardo, Malgorzata Sikora-Frac, Peter Colman, Olga Bulkina, ERNESTO GERMAN CARDONA MUÑOZ, Melanie Davies, JAIME CARMONA-HUERTA, Hertzel Gerstein, Jackie Bosch, Alina Babenko, Philip Aylward, Qifu Li, Yury Vasyuk, Asem Ali, Anna Novials, Andrzej Budaj, and Anne Taylor

Subjects
Male, medicine.medical_specialty, Randomization, Endocrinology, Diabetes and Metabolism, Insulin Glargine, 030204 cardiovascular system & hematology, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Risk Factors, law, Internal medicine, Diabetes mellitus, Fatty Acids, Omega-3, Internal Medicine, medicine, Humans, Hypoglycemic Agents, 030212 general & internal medicine, Myocardial infarction, Stroke, Aged, Proportional Hazards Models, Glycated Hemoglobin, Advanced and Specialized Nursing, Insulin glargine, business.industry, Hazard ratio, Middle Aged, medicine.disease, Metformin, Sulfonylurea Compounds, Treatment Outcome, Endocrinology, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Dietary Supplements, Female, business, Follow-Up Studies, medicine.drug
Abstract

OBJECTIVE The Outcome Reduction With Initial Glargine Intervention (ORIGIN) trial reported neutral effects of insulin glargine on cardiovascular outcomes and cancers and reduced incident diabetes in high–cardiovascular risk adults with dysglycemia after 6.2 years of active treatment. Omega-3 fatty acids had neutral effects on cardiovascular outcomes. The ORIGIN and Legacy Effects (ORIGINALE) study measured posttrial effects of these interventions during an additional 2.7 years. RESEARCH DESIGN AND METHODS Surviving ORIGIN participants attended up to two additional visits. The hazard of clinical outcomes during the entire follow-up period from randomization was calculated. RESULTS Of 12,537 participants randomized, posttrial data were analyzed for 4,718 originally allocated to insulin glargine (2,351) versus standard care (2,367), and 4,771 originally allocated to omega-3 fatty acid supplements (2,368) versus placebo (2,403). Posttrial, small differences in median HbA1c persisted (glargine 6.6% [49 mmol/mol], standard care 6.7% [50 mmol/mol], P = 0.025). From randomization to the end of posttrial follow-up, no differences were found between the glargine and standard care groups in myocardial infarction, stroke, or cardiovascular death (1,185 vs. 1,165 events; hazard ratio 1.01 [95% CI 0.94–1.10]; P = 0.72); myocardial infarction, stroke, cardiovascular death, revascularization, or hospitalization for heart failure (1,958 vs. 1,910 events; 1.03 [0.97–1.10]; P = 0.38); or any cancer (524 vs. 529 events; 0.99 [0.88–1.12]; P = 0.91) or between omega-3 and placebo groups in cardiovascular death (688 vs. 700; 0.98 [0.88–1.09]; P = 0.68) or other outcomes. CONCLUSIONS During >6 years of treatment followed by >2.5 years of observation, insulin glargine had neutral effects on health outcomes and salutary effects on metabolic control, whereas omega-3 fatty acid supplementation had no effect.

Published
2015
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48. Evaluación de la eficacia del ejercicio físico sobre la capacidad funcional de sujetos con enfermedad cardiovascular

Author

Mirary Mantilla-Morrón, Rodrigo Tepox Bruno, Miguel Urina-Triana, Daniela Urina-Jassir, Roberto rebolledo-Cobos, Luisa Galeano-Muñoz, and Luis Santiago Gómez

Subjects
Terapia de baile, Physical exercise, Cardiac rehabilitation, Ejercicio físico, Rehabilitación cardíaca, Dance therapy
Abstract

El entrenamiento aeróbico interválico (EAI) y la danza, pueden ser unos métodos apropiados para optimizar la resistencia aeróbica, umbral anaeróbico, función endotelial y cardiaca. El objetivo de este estudio fue comparar el EAI de moderada intensidad con la terapia de baile grupal y con el entrenamiento aeróbico continuo (EAC) sobre los cambios del VO2 pico en sujetos en fase II de tratamiento de rehabilitación cardiaca. Material y Métodos: Ensayo clínico aleatorio en sujetos con diagnóstico de cardiopatía isquémica en programa de rehabilitación cardiaca fase II. Se evaluaron tres programas de ejercicio físico: EAI, EAC y baile grupal, la capacidad funcional se evaluó mediante la prueba de caminata de seis minutos, antes y después de 12 sesiones de ejercicio. El VO2 pico se calculó con la fórmula modificada propuesta por el Colegio Americano de Medicina del Deporte. Resultados: Se incluyeron 30 sujetos (10 en cada grupo). El VO2 pico aumentó significativamente en todos los grupos después de 4 semanas, sin embargo, el grupo de entrenamiento aeróbico interválico (EAI) tuvo el mejor resultado y mejor capacidad funcional (MET). Conclusión: El EAI produjo mejor efecto en la capacidad funcional que los otros dos programas. Es necesario contar con más estudios para realizar una mejor evaluación a largo plazo de estos programas. Aerobic interval training (AIT) and dance can be appropriate methods to optimize aerobic endurance, anaerobic threshold, endothelial and cardiac function. The objective of this study was to compare moderate intensity AIT with group dance therapy and continuous aerobic training (CAT) on changes in peak oxygen uptake (VO2 peak) in subjects in phase II of cardiac rehabilitation treatment. Methods: Randomized clinical trial in patients diagnosed with ischemic heart disease in a phase II cardiac rehabilitation program. Three programs of physical exercise were evaluated: AIT, CAT and group dancing. Functional capacity was assessed by the six-minute walk test, before and after 12 exercise sessions. VO2 peak was calculated with the modified formula proposed by the American College of Sports Medicine. Results: 30 subjects were included (10 in each group). VO2 peak increased significantly in all groups after 4 weeks, however, the interval aerobic training group (IAS) had the best result and better functional capacity (MET). Conclusion: The IEA produced a better effect on functional capacity than the other two programs. It is necessary to have more studies to make a better long-term evaluation of these programs.

Published
2018

50. Anticoagulant therapy and outcomes in patients with prior or acute heart failure and acute coronary syndromes: Insights from the APixaban for PRevention of Acute ISchemic Events 2 trial

Author

Lars Wallentin, Dimitar Raev, Susanna R. Stevens, Viliam Fridrich, Megan L. Neely, Puneet Mohan, Robert A. Harrington, Stefan James, John H. Alexander, Dragos Vinereanu, John Amerena, Miguel Urina-Triana, Alex Gallegos Cazorla, Renato D. Lopes, Julie M. Miller, Jan H. Cornel, Yong Huo, and Danny Liaw

Subjects
Male, medicine.medical_specialty, Acute coronary syndrome, Pyridones, medicine.medical_treatment, Administration, Oral, Placebo, Electrocardiography, Internal medicine, medicine, Humans, Myocardial infarction, Acute Coronary Syndrome, Stroke, Aged, Retrospective Studies, Heart Failure, Dose-Response Relationship, Drug, business.industry, Hazard ratio, Thrombolysis, Middle Aged, medicine.disease, Treatment Outcome, Heart failure, Cardiology, Pyrazoles, Female, Apixaban, Cardiology and Cardiovascular Medicine, business, Factor Xa Inhibitors, Follow-Up Studies, medicine.drug
Abstract

Clinical outcomes and the effects of oral anticoagulants among patients with acute coronary syndrome (ACS) and either a history of or acute heart failure (HF) are largely unknown. We aimed to assess the relationship between prior HF or acute HF complicating an index ACS event and subsequent clinical outcomes and the efficacy and safety of apixaban compared with placebo in these populations.High-risk patients were randomly assigned post-ACS to apixaban 5.0 mg or placebo twice daily. Median follow-up was 8 (4-12) months. The primary outcome was cardiovascular death, myocardial infarction, or stroke. The main safety outcome was thrombolysis in myocardial infarction major bleeding.Heart failure was reported in 2,995 patients (41%), either as prior HF (2,076 [28%]) or acute HF (2,028 [27%]). Patients with HF had a very high baseline risk and were more often managed medically. Heart failure was associated with a higher rate of the primary outcome (prior HF: adjusted hazard ratio [HR] 1.73, 95% CI 1.42-2.10, P.0001, acute HF: adjusted HR 1.65, 95% CI 1.35-2.01, P.0001) and cardiovascular death (prior HF: HR 2.54, 95% CI 1.82-3.54, acute HF: adjusted HR 2.52, 95% CI 1.82-3.50). Patients with acute HF also had significantly higher rates of thrombolysis in myocardial infarction major bleeding (prior HF: adjusted HR 1.22, 95% CI 0.65-2.27, P = .54, acute HF: adjusted HR 1.78, 95% CI 1.03-3.08, P = .04). There was no statistical evidence of a differential effect of apixaban on clinical events or bleeding in patients with or without prior HF; however, among patients with acute HF, there were numerically fewer events with apixaban than placebo (14.8 vs 19.3, HR 0.76, 95% CI 0.57-1.01, interaction P = .13), a trend that was not seen in patients with prior HF or no HF.In high-risk patients post-ACS, both prior and acute HFs are associated with an increased risk of subsequent clinical events. Apixaban did not significantly reduce clinical events and increased bleeding in patients with and without HF; however, there was a tendency toward fewer clinical events with apixaban in patients with acute HF.

Published
2015
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