Search

Your search keyword '"Sarto, P"' showing total 30 results
Start Over Author "Sarto, P" Topic female
30 results on '"Sarto, P"'

1. Locus coeruleus integrity and neuropsychiatric symptoms in a cohort of early‐ and late‐onset Alzheimer's disease

Author

Falgàs, Neus, Peña‐González, Marta, Val‐Guardiola, Andrea, Pérez‐Millan, Agnès, Guillén, Núria, Sarto, Jordi, Esteller, Diana, Bosch, Beatriz, Fernández‐Villullas, Guadalupe, Tort‐Merino, Adrià, Mayà, Gerard, Augé, Josep Maria, Iranzo, Alex, Balasa, Mircea, Lladó, Albert, Morales‐Ruiz, Manuel, Bargalló, Núria, Muñoz‐Moreno, Emma, Grinberg, Lea T, and Sánchez‐Valle, Raquel

Subjects
Biological Psychology, Biomedical and Clinical Sciences, Psychology, Dementia, Acquired Cognitive Impairment, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Aging, Neurodegenerative, Brain Disorders, Neurosciences, Alzheimer's Disease, 2.1 Biological and endogenous factors, 4.2 Evaluation of markers and technologies, Neurological, Humans, Locus Coeruleus, Alzheimer Disease, Male, Female, Aged, Norepinephrine, Biomarkers, Magnetic Resonance Imaging, Middle Aged, Neuropsychological Tests, Cohort Studies, Age of Onset, Alzheimer's disease, early-onset Alzheimer's disease, locus coeruleus, neuromodulatory subcortical systems, neuropsychiatric symptoms, selective vulnerability, early‐onset Alzheimer's disease, Clinical Sciences, Geriatrics, Clinical sciences, Biological psychology
Abstract

IntroductionEarly-onset Alzheimer's disease (EOAD) shows a higher burden of neuropsychiatric symptoms than late-onset Alzheimer's disease (LOAD). We aim to determine the differences in the severity of neuropsychiatric symptoms and locus coeruleus (LC) integrity between EOAD and LOAD accounting for disease stage.MethodsOne hundred four subjects with AD diagnosis and 32 healthy controls were included. Participants underwent magnetic resonance imaging (MRI) to measure LC integrity, measures of noradrenaline levels in cerebrospinal fluid (CSF) and Neuropsychiatric Inventory (NPI). We analyzed LC-noradrenaline measurements and clinical and Alzheimer's disease (AD) biomarker associations.ResultsEOAD showed higher NPI scores, lower LC integrity, and similar levels of CSF noradrenaline compared to LOAD. Notably, EOAD exhibited lower LC integrity independently of disease stage. LC integrity negatively correlated with neuropsychiatric symptoms. Noradrenaline levels were increased in AD correlating with AD biomarkers.DiscussionDecreased LC integrity negatively contributes to neuropsychiatric symptoms. The higher LC degeneration in EOAD compared to LOAD could explain the more severe neuropsychiatric symptoms in EOAD.HighlightsLC degeneration is greater in early-onset AD (EOAD) compared to late-onset AD. Tau-derived LC degeneration drives a higher severity of neuropsychiatric symptoms. EOAD harbors a more profound selective vulnerability of the LC system. LC degeneration is associated with an increase of cerebrospinal fluid noradrenaline levels in AD.

Published
2024

2. Neighborhood Socioeconomic Status, Green Space, and Walkability and Risk for Falls Among Postmenopausal Women: The Women's Health Initiative

Author

Wende, Marilyn E, Lohman, Matthew C, Friedman, Daniela B, McLain, Alexander C, LaMonte, Michael J, Whitsel, Eric A, Shadyab, Aladdin H, Garcia, Lorena, Chrisinger, Benjamin W, Pan, Kathy, Bird, Chloe E, Sarto, Gloria E, and Kaczynski, Andrew T

Subjects
Public Health, Health Sciences, Clinical Research, Aging, Behavioral and Social Science, Rehabilitation, Humans, Female, Postmenopause, Social Class, Women's Health, Residence Characteristics, Walking, Paediatrics and Reproductive Medicine, Public Health and Health Services, Midwifery, Public health, Policy and administration
Abstract

PurposeThis study estimated associations between neighborhood socioeconomic status (NSES), walkability, green space, and incident falls among postmenopausal women and evaluated modifiers of these associations, including study arm, race and ethnicity, baseline household income, baseline walking, age at enrollment, baseline low physical functioning, baseline fall history, climate region, and urban-rural residence.MethodsThe Women's Health Initiative recruited a national sample of postmenopausal women (50-79 years) across 40 U.S. clinical centers and conducted yearly assessments from 1993 to 2005 (n = 161,808). Women reporting a history of hip fracture or walking limitations were excluded, yielding a final sample of 157,583 participants. Falling was reported annually. NSES (income/wealth, education, occupation), walkability (population density, diversity of land cover, nearby high-traffic roadways), and green space (exposure to vegetation) were calculated annually and categorized into tertiles (low, intermediate, high). Generalized estimating equations assessed longitudinal relationships.ResultsNSES was associated with falling before adjustment (high vs. low, odds ratio, 1.01; 95% confidence interval, 1.00-1.01). Walkability was significantly associated with falls after adjustment (high vs. low, odds ratio, 0.99; 95% confidence interval, 0.98-0.99). Green space was not associated with falling before or after adjustment. Study arm, race and ethnicity, household income, age, low physical functioning, fall history, and climate region modified the relationship between NSES and falling. Race and ethnicity, age, fall history, and climate region modified relationships between walkability and green space and falling.ConclusionsOur results did not show strong associations of NSES, walkability, or green space with falling. Future research should incorporate granular environmental measures that may directly relate to physical activity and outdoor engagement.

Published
2023

3. Network-based approaches elucidate differences within APOBEC and clock-like signatures in breast cancer

Author

Kim, Yoo-Ah, Wojtowicz, Damian, Sarto Basso, Rebecca, Sason, Itay, Robinson, Welles, Hochbaum, Dorit S, Leiserson, Mark DM, Sharan, Roded, Vadin, Fabio, and Przytycka, Teresa M

Subjects
Biological Sciences, Bioinformatics and Computational Biology, Breast Cancer, Cancer, Genetics, Human Genome, Aetiology, 2.2 Factors relating to the physical environment, 2.1 Biological and endogenous factors, APOBEC Deaminases, Breast Neoplasms, Female, Humans, Mutation, Phenotype, Mutational signature, Continuous cancer phenotype, Gene network, Network-phenotype association, Breast cancer, APOBEC, Clock-like signatures, Clinical Sciences
Abstract

BackgroundStudies of cancer mutations have typically focused on identifying cancer driving mutations that confer growth advantage to cancer cells. However, cancer genomes accumulate a large number of passenger somatic mutations resulting from various endogenous and exogenous causes, including normal DNA damage and repair processes or cancer-related aberrations of DNA maintenance machinery as well as mutations triggered by carcinogenic exposures. Different mutagenic processes often produce characteristic mutational patterns called mutational signatures. Identifying mutagenic processes underlying mutational signatures shaping a cancer genome is an important step towards understanding tumorigenesis.MethodsTo investigate the genetic aberrations associated with mutational signatures, we took a network-based approach considering mutational signatures as cancer phenotypes. Specifically, our analysis aims to answer the following two complementary questions: (i) what are functional pathways whose gene expression activities correlate with the strengths of mutational signatures, and (ii) are there pathways whose genetic alterations might have led to specific mutational signatures? To identify mutated pathways, we adopted a recently developed optimization method based on integer linear programming.ResultsAnalyzing a breast cancer dataset, we identified pathways associated with mutational signatures on both expression and mutation levels. Our analysis captured important differences in the etiology of the APOBEC-related signatures and the two clock-like signatures. In particular, it revealed that clustered and dispersed APOBEC mutations may be caused by different mutagenic processes. In addition, our analysis elucidated differences between two age-related signatures-one of the signatures is correlated with the expression of cell cycle genes while the other has no such correlation but shows patterns consistent with the exposure to environmental/external processes.ConclusionsThis work investigated, for the first time, a network-level association of mutational signatures and dysregulated pathways. The identified pathways and subnetworks provide novel insights into mutagenic processes that the cancer genomes might have undergone and important clues for developing personalized drug therapies.

Published
2020

4. Short Sleep Is Associated With Low Bone Mineral Density and Osteoporosis in the Women's Health Initiative

Author

Ochs‐Balcom, Heather M, Hovey, Kathleen M, Andrews, Christopher, Cauley, Jane A, Hale, Lauren, Li, Wenjun, Bea, Jennifer W, Sarto, Gloria E, Stefanick, Marcia L, Stone, Katie L, Watts, Nelson B, Zaslavsky, Oleg, and Wactawski‐Wende, Jean

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Osteoporosis, Clinical Research, Aging, Sleep Research, Prevention, Musculoskeletal, Good Health and Well Being, Absorptiometry, Photon, Bone Density, Cross-Sectional Studies, Female, Humans, Middle Aged, Osteoporosis, Postmenopausal, Sleep, Time Factors, Women's Health, SLEEP, SLEEP DURATION, BONE, DUAL-ENERGY X-RAY ABSORPTIOMETRY, BONE DENSITY, OSTEOPOROSIS, Biological Sciences, Engineering, Medical and Health Sciences, Anatomy & Morphology, Biological sciences, Biomedical and clinical sciences
Abstract

Short sleep duration, recognized as a public health epidemic, is associated with adverse health conditions, yet little is known about the association between sleep and bone health. We tested the associations of usual sleep behavior and bone mineral density (BMD) and osteoporosis. In a sample of 11,084 postmenopausal women from the Women's Health Initiative (WHI; mean age 63.3 years, SD = 7.4), we performed a cross-sectional study of the association of self-reported usual hours of sleep and sleep quality (WHI Insomnia Rating Score) with whole body, total hip, femoral neck, and spine BMD using linear regression models. We also studied the association of sleep duration and quality with dual-energy X-ray absorptiometry (DXA)-defined low bone mass (T-score

Published
2020

5. Relation of Pregnancy Loss to Risk of Cardiovascular Disease in Parous Postmenopausal Women (From the Women's Health Initiative)

Author

Hall, Philip S, Nah, Gregory, Vittinghoff, Eric, Parker, Donna R, Manson, JoAnn E, Howard, Barbara V, Sarto, Gloria E, Gass, Margery L, Sealy-Jefferson, Shawnita M, Salmoirago-Blotcher, Elena, Stefanick, Marcia L, Shadyab, Aladdin H, Van Horn, Linda V, Park, Ki, and Parikh, Nisha I

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Heart Disease, Prevention, Cardiovascular, Clinical Research, Aging, Good Health and Well Being, Abortion, Spontaneous, Cardiovascular Diseases, Female, Humans, Incidence, Middle Aged, Postmenopause, Pregnancy, Prospective Studies, Risk Assessment, Risk Factors, United States, Women's Health, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

Women with history of pregnancy loss (PL) have higher burden of cardiovascular disease (CVD) later in life, yet it is unclear whether this is attributable to an association with established CVD risk factors (RFs). We examined whether PL is associated with CVD RFs and biomarkers in parous postmenopausal women in the Women's Health Initiative, and whether the association between PL and CVD RFs accounted for the association between PL and incident CVD. Linear and logistic regressions were used to estimate associations between baseline history of PL and CVD RFs. Cox proportional hazards regression models were used to estimate the associations between baseline history of PL and incident CVD after adjustment for baseline RFs. Of 79,121 women, 27,272 (35%) had experienced PL. History of PL was associated with higher body mass index (p < 0.0001), hypertension (p < 0.0001), diabetes (p = 0.003), depression (p < 0.0001), and lower income (p < 0.0001), physical activity (p = 0.01), poorer diet (p < 0.0001), smoking (p < 0.0001), and alcohol use (p < 0.0001). After adjustment for CVD RFs, PL was significantly associated with incident CVD over mean follow up of 16 years (hazard ratio 1.11, 95% confidence interval 1.06 to 1.16). In conclusion, several CVD RFs are associated with PL, but they do not entirely account for the association between PL and incident CVD.

Published
2019

6. Association between Dietary Energy Density and Incident Type 2 Diabetes in the Women’s Health Initiative

Author

Hingle, Melanie D, Wertheim, Betsy C, Neuhouser, Marian L, Tinker, Lesley F, Howard, Barbara V, Johnson, Karen, Liu, Simin, Phillips, Lawrence S, Qi, Lihong, Sarto, Gloria, Turner, Tami, Waring, Molly E, and Thomson, Cynthia A

Subjects
Biomedical and Clinical Sciences, Epidemiology, Public Health, Health Sciences, Nutrition and Dietetics, Clinical Research, Diabetes, Aging, Nutrition, Prevention, Obesity, Metabolic and endocrine, Aged, Body Mass Index, Diabetes Mellitus, Type 2, Diet, Energy Intake, Female, Humans, Middle Aged, Nutrition Assessment, Postmenopause, Prospective Studies, Risk Factors, Surveys and Questionnaires, United States, Waist Circumference, Women's Health, Dietary energy density, Type 2 diabetes, Postmenopausal women, Dietary behavior, Diabetes prevention, Clinical Sciences, Anthropology, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundDietary energy density, or energy available in relation to gram intake, can inform disease risk.ObjectiveThe objective of this study was to investigate the association between baseline dietary energy density and risk of incident type 2 diabetes in postmenopausal women.DesignDietary energy density, weight status, and type 2 diabetes incidence were prospectively characterized in a large cohort of postmenopausal women participating in one or more clinical trials or an observational study.Participants/settingThe study involved 161,808 postmenopausal women recruited to the Women's Health Initiative observational study or clinical trials at 40 centers across the United States between 1993 and 1998.Main outcome measuresThe primary outcome was incident type 2 diabetes.Statistical analyses performedThe association between dietary energy density quintiles and incident diabetes was tested using Cox proportional hazards regression.ResultsA total of 143,204 participants without self-reported diabetes at enrollment completed baseline dietary assessment and were followed for 12.7±4.6 years. Risk of diabetes developing was 24% greater for women in the highest dietary energy density quintile compared with the lowest after adjusting for confounders (95% CI 1.17 to 1.32). Body mass index (calculated as kg/m2) and waist circumference mediated the relationship between dietary energy density and diabetes. In waist circumference-stratified analysis, women in dietary energy density quintiles 2 to 5 with waist circumferences >88 cm were at 9% to 12% greater risk of diabetes developing compared with women with waist circumference ≤88 cm.ConclusionsIn this prospective study, a higher baseline dietary energy density was associated with higher incidence of type 2 diabetes among postmenopausal women, both overall, and in women with elevated waist circumference.

Published
2017

7. Reproductive Factors and Incidence of Heart Failure Hospitalization in the Women's Health Initiative.

Author

Hall, Philip S, Nah, Gregory, Howard, Barbara V, Lewis, Cora E, Allison, Matthew A, Sarto, Gloria E, Waring, Molly E, Jacobson, Lisette T, Manson, JoAnn E, Klein, Liviu, and Parikh, Nisha I

Subjects
Humans, Gonadal Steroid Hormones, Stroke Volume, Reproductive History, Hospitalization, Incidence, Risk Factors, Cohort Studies, Postmenopause, Menarche, Ventricular Remodeling, Aged, Middle Aged, Women's Health, United States, Female, Heart Failure, Statistics as Topic, cardiovascular disease, menarche, menopause, pregnancy, women, Estrogen, Aging, Contraception/Reproduction, Cardiovascular, Heart Disease, 2.1 Biological and endogenous factors, Aetiology, Reproductive health and childbirth, Good Health and Well Being, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

BACKGROUND:Reproductive factors reflective of endogenous sex hormone exposure might have an effect on cardiac remodeling and the development of heart failure (HF). OBJECTIVES:This study examined the association between key reproductive factors and the incidence of HF. METHODS:Women from a cohort of the Women's Health Initiative were systematically evaluated for the incidence of HF hospitalization from study enrollment through 2014. Reproductive factors (number of live births, age at first pregnancy, and total reproductive duration [time from menarche to menopause]) were self-reported at study baseline in 1993 to 1998. We employed Cox proportional hazards regression analysis in age- and multivariable-adjusted models. RESULTS:Among 28,516 women, with an average age of 62.7 ± 7.1 years at baseline, 1,494 (5.2%) had an adjudicated incident HF hospitalization during an average follow-up of 13.1 years. After adjusting for covariates, total reproductive duration in years was inversely associated with incident HF: hazard ratios (HRs) of 0.99 per year (95% confidence interval [CI]: 0.98 to 0.99 per year) and 0.95 per 5 years (95% CI: 0.91 to 0.99 per 5 years). Conversely, early age at first pregnancy and nulliparity were significantly associated with incident HF in age-adjusted models, but not after multivariable adjustment. Notably, nulliparity was associated with incident HF with preserved ejection fraction in the fully adjusted model (HR: 2.75; 95% CI: 1.16 to 6.52). CONCLUSIONS:In post-menopausal women, shorter total reproductive duration was associated with higher risk of incident HF, and nulliparity was associated with higher risk for incident HF with preserved ejection fraction. Whether exposure to endogenous sex hormones underlies this relationship should be investigated in future studies.

Published
2017

8. Estrogen alone and health outcomes in black women by African ancestry

Author

Chlebowski, Rowan T, Barrington, Wendy, Aragaki, Aaron K, Manson, JoAnn E, Sarto, Gloria, O'Sullivan, Mary J, Wu, Daniel, Cauley, Jane A, Qi, Lihong, Wallace, Robert L, and Prentice, Ross L

Subjects
Biomedical and Clinical Sciences, Health Services and Systems, Public Health, Health Sciences, Oncology and Carcinogenesis, Reproductive Medicine, Rehabilitation, Clinical Research, Breast Cancer, Clinical Trials and Supportive Activities, Estrogen, Cancer, Aging, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Black or African American, Aged, Breast Neoplasms, Estrogen Replacement Therapy, Estrogens, Estrogens, Conjugated (USP), Female, Humans, Hysterectomy, Incidence, Middle Aged, Postmenopause, Postoperative Period, Proportional Hazards Models, Treatment Outcome, United States, African ancestry, Black women, Estrogen alone, Randomized trial, Women's Health Initiative, Medical and Health Sciences, Obstetrics & Reproductive Medicine, Biomedical and clinical sciences, Health sciences, Psychology
Abstract

ObjectiveIn postmenopausal black women in the Women's Health Initiative randomized trial, estrogen alone reduced breast cancers but its comprehensive influence on health outcomes in black women is unknown. Therefore, we examined this issue in the Women's Health Initiative overall and by African ancestry.MethodsA total of 1,616 black women with prior hysterectomy, including 1,061 with percent African ancestry determination, at 40 US centers were randomly assigned to conjugated equine estrogen (0.625 mg/d) or placebo for 7.2 years' (median) intervention with 13 years' cumulative follow-up. Coronary heart disease (CHD) and breast cancer were primary efficacy and safety outcomes, respectively. A global index also included stroke, colorectal cancer, hip fracture, pulmonary embolism, and death.ResultsBlack women in the estrogen-alone group compared with black women in the placebo group had fewer breast cancers (17 vs 40, hazard ratio [HR] 0.47, 95% CI 0.26-0.82). In women with more than 80% African ancestry, breast cancer HR was lower (0.32, 95% CI 0.12-0.86, trend P = 0.04 for ancestry effect). Most other outcomes including CHD, stroke, hip fracture, and the global index were null with estrogen use in black women; a global index effect was more favorable in younger black women (HR 0.65, 95% CI 0.43-0.98).ConclusionsIn black postmenopausal women with prior hysterectomy, estrogen alone significantly reduced breast cancer incidence with no adverse influence on CHD, venous thromboembolism, or all-cause mortality. Favorable estrogen-alone global index effects in younger black women warrant further study.

Published
2017

9. Physical impairment and body weight history in postmenopausal women: the Women’s Health Initiative

Author

Wanigatunga, Amal A, Sourdet, Sandrine S, LaMonte, Michael J, Waring, Molly E, Nassir, Rami, Garcia, Lorena, Bea, Jennifer W, Seguin, Rebecca A, Ockene, Judith K, Sarto, Gloria E, Stefanick, Marcia L, Limacher, Marian, and Manini, Todd M

Subjects
Public Health, Biomedical and Clinical Sciences, Nutrition and Dietetics, Health Sciences, Prevention, Nutrition, Clinical Research, Obesity, Aging, Cancer, Stroke, Metabolic and endocrine, Aged, Body Mass Index, Body Weight, Female, Health Status, Humans, Middle Aged, Mobility Limitation, Overweight, Postmenopause, Risk Factors, Women's Health, Body weight, Weight change, BMI, Physical impairment, Physical function, Disability, Women’s Health Initiative Investigators, Medical and Health Sciences, Nutrition & Dietetics, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveTo examine whether weight history and weight transitions over adult lifespan contribute to physical impairment among postmenopausal women.DesignBMI categories were calculated among postmenopausal women who reported their weight and height at age 18 years. Multiple-variable logistic regression was used to determine the association between BMI at age 18 years and BMI transitions over adulthood on severe physical impairment (SPI), defined as scoring

Published
2016

10. Prospective Analysis of Health and Mortality Risk in Veteran and Non-Veteran Participants in the Women's Health Initiative

Author

Weitlauf, Julie C, LaCroix, Andrea Z, Bird, Chloe E, Woods, Nancy F, Washington, Donna L, Katon, Jodie G, LaMonte, Michael J, Goldstein, Mary K, Bassuk, Shari S, Sarto, Gloria E, and Stefanick, Marcia L

Subjects
Clinical Research, Cancer, Prevention, Rehabilitation, Aging, Good Health and Well Being, Adult, Age Distribution, Aged, Cardiovascular Diseases, Cause of Death, Diabetes Mellitus, Female, Follow-Up Studies, Health Status Indicators, Humans, Middle Aged, Mortality, Neoplasms, Proportional Hazards Models, Prospective Studies, Risk Factors, United States, Veterans, Women's Health, Paediatrics and Reproductive Medicine, Public Health and Health Services, Public Health
Abstract

BackgroundThe health of postmenopausal women veterans is a neglected area of study. A stronger empirical evidence base is needed, and would inform the provision of health care for the nearly 1 million U.S. women veterans currently 50 years of age or older. To this end, the present work compares salient health outcomes and risk of all-cause mortality among veteran and non-veteran participants of the Women's Health Initiative (WHI).MethodsThis study features prospective analysis of long-term health outcomes and mortality risk (average follow-up, 8 years) among the 3,706 women veterans and 141,009 non-veterans who participated in the WHI Observational Study or Clinical Trials. Outcome measurements included confirmed incident cases of cardiovascular disease (CVD), cancer, diabetes, hip fractures, and all-cause mortality.ResultsWe identified 17,968 cases of CVD, 19,152 cases of cancer, 18,718 cases of diabetes, 2,817 cases of hip fracture, and 13,747 deaths. In Cox regression models adjusted for age, sociodemographic variables, and health risk factors, veteran status was associated with significantly increased risk of all-cause mortality (hazard ratio [HR], 1.13; 95% CI, 1.03-1.23), but not with risk of CVD (HR, 1.00; 95% CI, 0.90-1.11), cancer (HR, 1.04; 95% CI, 0.95-1.14), hip fracture (HR, 1.16; 95% CI, 0.94-1.43), or diabetes (HR, 1.00; 95% CI, 0.89-1.1).ConclusionsWomen veterans' postmenopausal health, particularly risk for all-cause mortality, warrants further consideration. In particular, efforts to identify and address modifiable risk factors associated with all-cause mortality are needed.

Published
2015

11. Statin use and risk of haemorrhagic stroke in a community-based cohort of postmenopausal women: an observational study from the Women's Health Initiative

Author

Salmoirago-Blotcher, Elena, Hovey, Kathleen M, Andrews, Christopher A, Robinson, Jennifer G, Johnson, Karen C, Wassertheil-Smoller, Sylvia, Crawford, Sybil, Qi, Lihong, Martin, Lisa W, Ockene, Judith, Manson, JoAnn E, Nabel, Elizabeth, Rossouw, Jacques, Ludlam, Shari, McGowan, Joan, Ford, Leslie, Geller, Nancy, Prentice, Ross, Anderson, Garnet, LaCroix, Andrea, Kooperberg, Charles L, Patterson, Ruth E, McTiernan, Anne, Stein, Evan, Cummings, Steven, Rajkovic, Aleksandar, Eaton, Charles B, Phillips, Lawrence, Beresford, Shirley, Chlebowski, Rowan, Michael, Yvonne, Caan, Bette, Kotchen, Jane Morley, Howard, Barbara V, Van Horn, Linda, Black, Henry, Stefanick, Marcia L, Lane, Dorothy, Jackson, Rebecca, Lewis, Cora E, Thomson, Cynthia A, Wactawski-Wende, Jean, Robbins, John, Hubbell, F Allan, Nathan, Lauren, Langer, Robert D, Gass, Margery, Limacher, Marian, Curb, J David, Wallace, Robert, Lasser, Norman, O'Sullivan, Mary Jo, Margolis, Karen, Brunner, Robert, Heiss, Gerardo, Kuller, Lewis, Brzyski, Robert, Sarto, Gloria E, Vitolins, Mara, Simon, Michael, and Shumaker, Sally

Subjects
Biomedical and Clinical Sciences, Public Health, Health Sciences, Aging, Women's Health, Clinical Research, Cerebrovascular, Prevention, Stroke, Female, Follow-Up Studies, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Middle Aged, Postmenopause, Proportional Hazards Models, Retrospective Studies, Risk Factors, PREVENTIVE MEDICINE, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences, Biomedical and clinical sciences, Health sciences, Psychology
Abstract

ObjectivesTo determine whether statin treatment is associated with increased risk of haemorrhagic stroke (HS) in older women. A secondary objective was to evaluate HS risk in users of combined statin and antiplatelet treatment.DesignObservational study: secondary data analysis from the Women's Health Initiative (WHI) clinical trials.SettingWomen were recruited from 40 participating sites.ParticipantsCohort of 68,132 women followed through 2005 (parent study) and for an additional 5 years in the extension study.Main outcome measuresStatin use was assessed at baseline and at follow-up visits (1, 3, 6 and 9 years). Women brought medications in original containers for inventory. Strokes were ascertained semiannually and centrally adjudicated. Risk of HS by statin use (time-varying covariate, with the 'no use' category as the referent) was estimated from Cox proportional hazard regression models adjusted for age (model 1); risk factors for HS (model 2); and possible confounders by indication (model 3). Prespecified subgroup analyses were conducted by use of antiplatelet medications.ResultsFinal models included 67,882 women (mean age, 63±7 years). Over a mean follow-up of 12 years, incidence rates of HS were 6.4/10,000 person-years among statin users and 5.0/10,000 person-years among non-users (p=0.11). The unadjusted risk of HS in statin users was 1.21 (CI 0.96 to 1.53); after adjusting for age and HS risk factors the HR was 0.98 (CI 0.76 to 1.26). Risk of HS was higher among women on statins and antiplatelet agents versus women on antiplatelet medications alone (HR=1.59; CI 1.03 to 2.47); p for interaction=0.011.ConclusionsThis retrospective analysis did not show an association between statin use and HS risk among older women. HS risk was higher among women taking statins with antiplatelet agents. These findings warrant further investigation, given potential implications for clinical decision-making.

Published
2015

12. Association of Sickle Cell Trait With Chronic Kidney Disease and Albuminuria in African Americans

Author

Naik, Rakhi P, Derebail, Vimal K, Grams, Morgan E, Franceschini, Nora, Auer, Paul L, Peloso, Gina M, Young, Bessie A, Lettre, Guillaume, Peralta, Carmen A, Katz, Ronit, Hyacinth, Hyacinth I, Quarells, Rakale C, Grove, Megan L, Bick, Alexander G, Fontanillas, Pierre, Rich, Stephen S, Smith, Joshua D, Boerwinkle, Eric, Rosamond, Wayne D, Ito, Kaoru, Lanzkron, Sophie, Coresh, Josef, Correa, Adolfo, Sarto, Gloria E, Key, Nigel S, Jacobs, David R, Kathiresan, Sekar, Bibbins-Domingo, Kirsten, Kshirsagar, Abhijit V, Wilson, James G, and Reiner, Alexander P

Subjects
Epidemiology, Health Sciences, Minority Health, Hematology, Kidney Disease, Atherosclerosis, Rare Diseases, Sickle Cell Disease, Cardiovascular, Renal and urogenital, Adult, Black or African American, Aged, Albuminuria, Cohort Studies, Female, Glomerular Filtration Rate, Humans, Male, Middle Aged, Prospective Studies, Renal Insufficiency, Chronic, Risk, Sickle Cell Trait, United States, Young Adult, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

ImportanceThe association between sickle cell trait (SCT) and chronic kidney disease (CKD) is uncertain.ObjectiveTo describe the relationship between SCT and CKD and albuminuria in self-identified African Americans.Design, setting, and participantsUsing 5 large, prospective, US population-based studies (the Atherosclerosis Risk in Communities Study [ARIC, 1987-2013; n = 3402], Jackson Heart Study [JHS, 2000-2012; n = 2105], Coronary Artery Risk Development in Young Adults [CARDIA, 1985-2006; n = 848], Multi-Ethnic Study of Atherosclerosis [MESA, 2000-2012; n = 1620], and Women's Health Initiative [WHI, 1993-2012; n = 8000]), we evaluated 15,975 self-identified African Americans (1248 participants with SCT [SCT carriers] and 14,727 participants without SCT [noncarriers]).Main outcomes and measuresPrimary outcomes were CKD (defined as an estimated glomerular filtration rate [eGFR] of 30 mg/g or albumin excretion rate >30 mg/24 hours), and decline in eGFR (defined as a decrease of >3 mL/min/1.73 m2 per year). Effect sizes were calculated separately for each cohort and were subsequently meta-analyzed using a random-effects model.ResultsA total of 2233 individuals (239 of 1247 SCT carriers [19.2%] vs 1994 of 14,722 noncarriers [13.5%]) had CKD, 1298 (140 of 675 SCT carriers [20.7%] vs 1158 of 8481 noncarriers [13.7%]) experienced incident CKD, 1719 (150 of 665 SCT carriers [22.6%] vs 1569 of 8249 noncarriers [19.0%]) experienced decline in eGFR, and 1322 (154 of 485 SCT carriers [31.8%] vs 1168 of 5947 noncarriers [19.6%]) had albuminuria during the study period. Individuals with SCT had an increased risk of CKD (odds ratio [OR], 1.57 [95% CI, 1.34-1.84]; absolute risk difference [ARD], 7.6% [95% CI, 4.7%-10.8%]), incident CKD (OR, 1.79 [95% CI, 1.45-2.20]; ARD, 8.5% [95% CI, 5.1%-12.3%]), and decline in eGFR (OR, 1.32 [95% CI, 1.07-1.61]; ARD, 6.1% [95% CI, 1.4%-13.0%]) compared with noncarriers. Sickle cell trait was also associated with albuminuria (OR, 1.86 [95% CI, 1.49-2.31]; ARD, 12.6% [95% CI, 7.7%-17.7%]).Conclusions and relevanceAmong African Americans in these cohorts, the presence of SCT was associated with an increased risk of CKD, decline in eGFR, and albuminuria, compared with noncarriers. These findings suggest that SCT may be associated with the higher risk of kidney disease in African Americans.

Published
2014

13. Body mass index, physical activity, and mortality in women diagnosed with ovarian cancer: Results from the Women's Health Initiative

Author

Zhou, Yang, Chlebowski, Rowan, LaMonte, Michael J, Bea, Jennifer W, Qi, Lihong, Wallace, Robert, Lavasani, Sayeh, Walsh, Brian W, Anderson, Garnet, Vitolins, Mara, Sarto, Gloria, and Irwin, Melinda L

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Rare Diseases, Prevention, Nutrition, Obesity, Clinical Research, Ovarian Cancer, Good Health and Well Being, Aged, Body Mass Index, Cause of Death, Cohort Studies, Exercise, Female, Humans, Middle Aged, Motor Activity, Ovarian Neoplasms, Overweight, Proportional Hazards Models, Prospective Studies, Risk Factors, Ovarian cancer, Weight, Physical activity, Mortality, Paediatrics and Reproductive Medicine, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis, Reproductive medicine
Abstract

BackgroundOvarian cancer is often diagnosed at late stages and consequently the 5-year survival rate is only 44%. However, there is limited knowledge of the association of modifiable lifestyle factors, such as physical activity and obesity on mortality among women diagnosed with ovarian cancer. The purpose of our study was to prospectively investigate the association of (1) measured body mass index (BMI), and (2) self-reported physical activity with ovarian cancer-specific and all-cause mortality in postmenopausal women enrolled in the Women's Health Initiative (WHI).MethodsParticipants were 600 women diagnosed with primary ovarian cancer subsequent to enrollment in WHI. Exposure data, including measured height and weight and reported physical activity from recreation and walking, used in this analysis were ascertained at the baseline visit for the WHI. Cox proportional hazard regression was used to examine the associations between BMI, physical activity and mortality endpoints.ResultsVigorous-intensity physical activity was associated with a 26% lower risk of ovarian cancer specific-mortality (HR=0.74; 95% CI: 0.56-0.98) and a 24% lower risk of all-cause mortality (HR=0.76; 95% CI: 0.58-0.98) compared to no vigorous-intensity physical activity. BMI was not associated with mortality.ConclusionsParticipating in vigorous-intensity physical activity, assessed prior to ovarian cancer diagnosis, appears to be associated with a lower risk of ovarian cancer mortality.

Published
2014

14. Women’s Health Initiative clinical trials

Author

Robbins, John A, Aragaki, Aaron, Crandall, Carolyn J, Manson, JoAnn E, Carbone, Laura, Jackson, Rebecca, Lewis, Cora Elizabeth, Johnson, Karen C, Sarto, Gloria, Stefanick, Marcia L, and Wactawski-Wende, Jean

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Dietary Supplements, Prevention, Estrogen, Osteoporosis, Nutrition, Women's Health, Clinical Research, Clinical Trials and Supportive Activities, Aging, 6.1 Pharmaceuticals, Musculoskeletal, Aged, Bone Density, Calcium, Cholecalciferol, Double-Blind Method, Drug Interactions, Drug Synergism, Estrogen Replacement Therapy, Female, Hip Fractures, Humans, Medroxyprogesterone Acetate, Middle Aged, Placebos, Prospective Studies, United States, Vitamin D, Hormone therapy, Estrogens, Medical and Health Sciences, Obstetrics & Reproductive Medicine, Biomedical and clinical sciences, Health sciences, Psychology
Abstract

ObjectiveThis study aims to test the added value of calcium and vitamin D (CaD) in fracture prevention among women taking postmenopausal hormone therapy (HT).MethodsThis is a prospective, partial-factorial, randomized, controlled, double-blind trial among Women's Health Initiative postmenopausal participants aged 50 to 79 years at 40 centers in the United States with a mean follow-up of 7.2 years. A total of 27,347 women were randomized to HT (0.625 mg of conjugated estrogens alone, or 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate daily), and 36,282 women were randomized to 1,000 mg of elemental calcium (carbonate) plus 400 IU of vitamin D3 daily, each compared with placebo. A total of 16,089 women participated in both arms. The predefined outcomes were adjudicated hip fractures and measured bone mineral density.ResultsInteraction between HT and CaD on hip fracture (P interaction = 0.01) was shown. The effect of CaD was stronger among women assigned to HT (hazard ratio [HR], 0.59; 95% CI, 0.38-0.93) than among women assigned to placebo (HR, 1.20; 95% CI, 0.85-1.69). The effect of HT on hip fracture was stronger among women assigned to active CaD (HR, 0.43; 95% CI, 0.28-0.66) than among women assigned to placebo (HR, 0.87; 95% CI, 0.60-1.26). CaD supplementation enhanced the antifracture effect of HT at all levels of personal calcium intake. There was no interaction between HT and CaD on change in hip or spine bone mineral density.ConclusionsPostmenopausal women at normal risk for hip fracture who are on CaD supplementation experience significantly reduced incident hip fractures beyond HT alone at all levels of personal baseline total calcium intake.

Published
2014

15. Nutrition and Physical Activity Cancer Prevention Guidelines, Cancer Risk, and Mortality in the Women's Health Initiative

Author

Thomson, Cynthia A, McCullough, Marjorie L, Wertheim, Betsy C, Chlebowski, Rowan T, Martinez, Maria Elena, Stefanick, Marcia L, Rohan, Thomas E, Manson, JoAnn E, Tindle, Hilary A, Ockene, Judith, Vitolins, Mara Z, Wactawski-Wende, Jean, Sarto, Gloria E, Lane, Dorothy S, and Neuhouser, Marian L

Subjects
Cancer, Colo-Rectal Cancer, Behavioral and Social Science, Digestive Diseases, Prevention, Aging, Nutrition, Breast Cancer, Prevention of disease and conditions, and promotion of well-being, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing, Good Health and Well Being, Aged, Alcohol Drinking, Body Mass Index, Diet, Ethnicity, Exercise, Female, Follow-Up Studies, Guidelines as Topic, Humans, Incidence, Life Style, Motor Activity, Neoplasms, Postmenopause, Prospective Studies, Risk Factors, Women's Health, Ethnic Groups, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Healthy lifestyle behaviors are recommended to reduce cancer risk and overall mortality. Adherence to cancer-preventive health behaviors and subsequent cancer risk has not been evaluated in a diverse sample of postmenopausal women. We examined the association between the American Cancer Society (ACS) Nutrition and Physical Activity Cancer Prevention Guidelines score and risk of incident cancer, cancer-specific mortality, and all-cause mortality in 65,838 postmenopausal women enrolled in the Women's Health Initiative Observational Study. ACS guidelines scores (0-8 points) were determined from a combined measure of diet, physical activity, body mass index (current and at age 18 years), and alcohol consumption. After a mean follow-up of 12.6 years, 8,632 incident cancers and 2,356 cancer deaths were identified. The highest ACS guidelines scores compared with the lowest were associated with a 17% lower risk of any cancer [HR, 0.83; 95% confidence interval (CI), 0.75-0.92], 22% lower risk of breast cancer (HR, 0.78; 95% CI, 0.67-0.92), 52% lower risk of colorectal cancer (HR, 0.48; 95% CI, 0.32-0.73), 27% lower risk of all-cause mortality, and 20% lower risk of cancer-specific mortality (HR, 0.80; 95% CI, 0.71-0.90). Associations with lower cancer incidence and mortality were generally strongest among Asian, black, and Hispanic women and weakest among non-Hispanic whites. Behaviors concordant with Nutrition and Physical Activity Cancer Prevention Guidelines were associated with lower risk of total, breast, and colorectal cancers and lower cancer-specific mortality in postmenopausal women.

Published
2014

16. Determinants of Racial/Ethnic Disparities in Incidence of Diabetes in Postmenopausal Women in the U.S. The Women’s Health Initiative 1993–2009

Author

Ma, Yunsheng, Hébert, James R, Manson, JoAnn E, Balasubramanian, Raji, Liu, Simin, Lamonte, Michael J, Bird, Chloe E, Ockene, Judith K, Qiao, Yongxia, Olendzki, Barbara, Schneider, Kristin L, Rosal, Milagros C, Sepavich, Deidre M, Wactawski-Wende, Jean, Stefanick, Marcia L, Phillips, Lawrence S, Ockene, Ira S, Kaplan, Robert C, Sarto, Gloria E, Garcia, Lorena, and Howard, Barbara V

Subjects
Epidemiology, Biomedical and Clinical Sciences, Public Health, Health Sciences, Diabetes, Nutrition, Minority Health, Prevention, Metabolic and endocrine, Aged, Diabetes Mellitus, Female, Humans, Incidence, Middle Aged, Postmenopause, United States, Medical and Health Sciences, Endocrinology & Metabolism, Biomedical and clinical sciences, Health sciences
Abstract

ObjectiveTo examine determinants of racial/ethnic differences in diabetes incidence among postmenopausal women participating in the Women's Health Initiative.Research design and methodsData on race/ethnicity, baseline diabetes prevalence, and incident diabetes were obtained from 158,833 women recruited from 1993-1998 and followed through August 2009. The relationship between race/ethnicity, other potential risk factors, and the risk of incident diabetes was estimated using Cox proportional hazards models from which hazard ratios (HRs) and 95% CIs were computed.ResultsParticipants were aged 63 years on average at baseline. The racial/ethnic distribution was 84.1% non-Hispanic white, 9.2% non-Hispanic black, 4.1% Hispanic, and 2.6% Asian. After an average of 10.4 years of follow-up, compared with whites and adjusting for potential confounders, the HRs for incident diabetes were 1.55 for blacks (95% CI 1.47-1.63), 1.67 for Hispanics (1.54-1.81), and 1.86 for Asians (1.68-2.06). Whites, blacks, and Hispanics with all factors (i.e., weight, physical activity, dietary quality, and smoking) in the low-risk category had 60, 69, and 63% lower risk for incident diabetes. Although contributions of different risk factors varied slightly by race/ethnicity, most findings were similar across groups, and women who had both a healthy weight and were in the highest tertile of physical activity had less than one-third the risk of diabetes compared with obese and inactive women.ConclusionsDespite large racial/ethnic differences in diabetes incidence, most variability could be attributed to lifestyle factors. Our findings show that the majority of diabetes cases are preventable, and risk reduction strategies can be effectively applied to all racial/ethnic groups.

Published
2012

17. The Effect of Calcium plus Vitamin D on Risk for Invasive Cancer: Results of the Women's Health Initiative (WHI) Calcium Plus Vitamin D Randomized Clinical Trial

Author

Brunner, Robert L, Wactawski-Wende, Jean, Caan, Bette J, Cochrane, Barbara B, Chlebowski, Rowan T, Gass, Margery LS, Jacobs, Elizabeth T, LaCroix, Andrea Z, Lane, Dorothy, Larson, Joseph, Margolis, Karen L, Millen, Amy E, Sarto, Gloria E, Vitolins, Mara Z, and Wallace, Robert B

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Cancer, Aging, Digestive Diseases, Women's Health, Clinical Research, Clinical Trials and Supportive Activities, Colo-Rectal Cancer, Complementary and Integrative Health, Prevention, Nutrition, Dietary Supplements, 6.1 Pharmaceuticals, 3.3 Nutrition and chemoprevention, Good Health and Well Being, Aged, Bone Density Conservation Agents, Calcium, Dietary, Cholecalciferol, Double-Blind Method, Female, Follow-Up Studies, Humans, Incidence, Middle Aged, Mortality, Neoplasms, Patient Compliance, Postmenopause, Proportional Hazards Models, Nutrition and Dietetics, Nutrition & Dietetics, Nutrition and dietetics, Oncology and carcinogenesis
Abstract

In the Women's Health Initiative (WHI) trial of calcium plus vitamin D (CaD), we examined the treatment effect on incidence and mortality for all invasive cancers. Postmenopausal women (N = 36,282) were randomized to 1,000 mg of elemental calcium with 400 IU vitamin D3 or placebo. Cox models estimated risk of cancer incidence and mortality. After 7.0 yr, 1,306 invasive cancers were diagnosed in the supplement and 1,333 in the placebo group [hazard ratio (HR) = 0.98; CI = 0.90, 1.05, unweighted P = 0.54]. Mortality did not differ between supplement (315, annualized% = .26) and placebo [(347, 0.28%; P = 0.17; HR = 0.90 (0.77, 1.05)]. Significant treatment interactions on incident cancer were found for family history of cancer, personal total intake of vitamin D, smoking, and WHI dietary trial randomized group. Calcium/vitamin D supplementation did not reduce invasive cancer incidence or mortality. Supplementation lowered cancer risk in the WHI healthy diet trial arm and in women without a first-degree relative with cancer. The interactions are only suggestive given multiple testing considerations. The low vitamin D dose provided, limited adherence, and lack of serum 25(OH)D values should be considered when interpreting these findings.

Published
2011

18. Characterization of the association between 8q24 and colon cancer: gene-environment exploration and meta-analysis.

Author

Hutter, Carolyn M, Slattery, Martha L, Duggan, David J, Muehling, Jill, Curtin, Karen, Hsu, Li, Beresford, Shirley AA, Rajkovic, Aleksandar, Sarto, Gloria E, Marshall, James R, Hammad, Nazik, Wallace, Robert, Makar, Karen W, Prentice, Ross L, Caan, Bette J, Potter, John D, and Peters, Ulrike

Subjects
Chromosomes, Human, Pair 8, Humans, Colonic Neoplasms, Genetic Predisposition to Disease, Neoplasm Staging, Logistic Models, Odds Ratio, Risk Assessment, Risk Factors, Case-Control Studies, Life Style, Environment, Linkage Disequilibrium, Phenotype, Polymorphism, Single Nucleotide, Adult, Aged, Middle Aged, United States, Female, Male, Genetic Association Studies, Chromosomes, Human, Pair 8, Polymorphism, Single Nucleotide, Oncology and Carcinogenesis, Public Health and Health Services, Oncology & Carcinogenesis
Abstract

BackgroundGenome-wide association studies and subsequent replication studies have shown that single nucleotide polymorphisms (SNPs) in the chromosomal region 8q24 are associated with colorectal cancer susceptibility.MethodsWe examined 11 SNP markers in the 8q24 region between 128.47 and 128.54 Mb, using a total of 1,987 colon cases and 2,339 controls who self-reported as white from two independent, well-characterized study populations. Analysis was performed separately within each study, and combined using random effects meta-analysis. Logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (95% CIs) and to test for effect modification by known colon cancer risk factors. We also performed a meta-analysis combining our results with previous studies.ResultsWe observed evidence of association for four SNPs in low to high linkage disequilibrium (r2 ranging from 0.18 to 0.93) localized in a 16.2 kb region defined by rs10505477 and rs1056368. The combined results for our two studies of colon cancer showed an OR of 1.10 (95% CI: 1.01-1.20, Ptrend = 0.023), and a meta-analysis of our results with previously reported studies of colon and colorectal cancer strongly support the association for this SNP (combined OR for rs6983267 = 1.21, 95% CI: 1.18-1.24, p = 5.5 × 10-44). We did not observe any notable evidence of effect modification by known colon cancer risk factors, and risk did not differ significantly by tumor site or stage.ConclusionsOur study confirms the association between polymorphisms on chromosome 8q24 and colon cancer risk and suggests that the susceptibility locus in region 8q24 is not strongly modified by various lifestyle, environmental, and demographic risk factors for colon cancer.

Published
2010

19. Resting heart rate as a low tech predictor of coronary events in women: prospective cohort study

Author

Hsia, Judith, Larson, Joseph C, Ockene, Judith K, Sarto, Gloria E, Allison, Matthew A, Hendrix, Susan L, Robinson, Jennifer G, LaCroix, Andrea Z, Manson, JoAnn E, and Group, for the Women’s Health Initiative Research

Subjects
Biomedical and Clinical Sciences, Epidemiology, Public Health, Health Sciences, Reproductive Medicine, Clinical Research, Aging, Heart Disease, Heart Disease - Coronary Heart Disease, Cardiovascular, Aged, Death, Sudden, Cardiac, Epidemiologic Methods, Female, Heart Rate, Humans, Middle Aged, Myocardial Infarction, Postmenopause, Prognosis, Rest, Stroke, Women's Health Initiative Research Group, Clinical Sciences, Public Health and Health Services, General & Internal Medicine, Biomedical and clinical sciences, Health sciences, Psychology
Abstract

ObjectiveTo evaluate resting heart rate as an independent predictor of cardiovascular risk in women.DesignProspective cohort study.SettingThe Women's Health Initiative was undertaken at 40 research clinics in the United States.Participants129 135 postmenopausal women.Main outcome measureClinical cardiovascular events.ResultsDuring a mean of 7.8 (SD 1.6) years of follow up, 2281 women were identified with myocardial infarction or coronary death and 1877 with stroke. We evaluated associations between resting heart rate and cardiovascular events in Cox regression models adjusted for multiple covariates. Higher resting heart rate was independently associated with coronary events (hazard ratio 1.26, 95% confidence interval 1.11 to 1.42 for highest [>76 beats per minute] v lowest quintile [ConclusionResting heart rate, a low tech and inexpensive measure of autonomic tone, independently predicts myocardial infarction or coronary death, but not stroke, in women.Trial registrationClinicalTrials.gov NCT00000611.

Published
2009

20. Serum 25-hydroxyvitamin D concentrations and risk for hip fractures.

Author

Cauley, Jane A, Lacroix, Andrea Z, Wu, LieLing, Horwitz, Mara, Danielson, Michelle E, Bauer, Doug C, Lee, Jennifer S, Jackson, Rebecca D, Robbins, John A, Wu, Chunyuan, Stanczyk, Frank Z, LeBoff, Meryl S, Wactawski-Wende, Jean, Sarto, Gloria, Ockene, Judith, and Cummings, Steven R

Subjects
Complementary and Integrative Health, Clinical Research, Aging, Physical Injury - Accidents and Adverse Effects, Osteoporosis, Nutrition, Musculoskeletal, Accidental Falls, Adrenal Cortex Hormones, Aged, Body Mass Index, Bone Resorption, Case-Control Studies, Female, Frail Elderly, Gonadal Steroid Hormones, Health Status, Hip Fractures, Humans, Middle Aged, Odds Ratio, Physical Fitness, Risk Factors, Smoking, Vitamin D, Clinical Sciences, Public Health and Health Services
Abstract

BackgroundThe relationship between serum 25-hydroxyvitamin D [25(OH) vitamin D] concentration and hip fractures is unclear.ObjectiveTo see whether low serum 25(OH) vitamin D concentrations are associated with hip fractures in community-dwelling women.DesignNested case-control study.Setting40 clinical centers in the United States.Participants400 case-patients with incident hip fracture and 400 control participants matched on the basis of age, race or ethnicity, and date of blood draw. Both groups were selected from 39 795 postmenopausal women who were not using estrogens or other bone-active therapies and who had not had a previous hip fracture.MeasurementsSerum 25(OH) vitamin D was measured and patients were followed for a median of 7.1 years (range, 0.7 to 9.3 years) to assess fractures.ResultsMean serum 25(OH) vitamin D concentrations were lower in case-patients than in control participants (55.95 nmol/L [SD, 20.28] vs. 59.60 nmol/L [SD, 18.05]; P = 0.007), and lower serum 25(OH) vitamin D concentrations increased hip fracture risk (adjusted odds ratio for each 25-nmol/L decrease, 1.33 [95% CI, 1.06 to 1.68]). Women with the lowest 25(OH) vitamin D concentrations (< or =47.5 nmol/L) had a higher fracture risk than did those with the highest concentrations (> or =70.7 nmol/L) (adjusted odds ratio, 1.71 [CI, 1.05 to 2.79]), and the risk increased statistically significantly across quartiles of serum 25(OH) vitamin D concentration (P for trend = 0.016). This association was independent of number of falls, physical function, frailty, renal function, and sex-steroid hormone levels and seemed to be partially mediated by bone resorption.LimitationsFew case-patients were nonwhite women. Bone mineral density and parathyroid hormone levels were not accounted for in the analysis.ConclusionLow serum 25(OH) vitamin D concentrations are associated with a higher risk for hip fracture.

Published
2008

21. Calcium plus Vitamin D Supplementation and the Risk of Fractures

Author

Jackson, Rebecca D, LaCroix, Andrea Z, Gass, Margery, Wallace, Robert B, Robbins, John, Lewis, Cora E, Bassford, Tamsen, Beresford, Shirley AA, Black, Henry R, Blanchette, Patricia, Bonds, Denise E, Brunner, Robert L, Brzyski, Robert G, Caan, Bette, Cauley, Jane A, Chlebowski, Rowan T, Cummings, Steven R, Granek, Iris, Hays, Jennifer, Heiss, Gerardo, Hendrix, Susan L, Howard, Barbara V, Hsia, Judith, Hubbell, F Allan, Johnson, Karen C, Judd, Howard, Kotchen, Jane Morley, Kuller, Lewis H, Langer, Robert D, Lasser, Norman L, Limacher, Marian C, Ludlam, Shari, Manson, JoAnn E, Margolis, Karen L, McGowan, Joan, Ockene, Judith K, O'Sullivan, Mary Jo, Phillips, Lawrence, Prentice, Ross L, Sarto, Gloria E, Stefanick, Marcia L, Van Horn, Linda, Wactawski-Wende, Jean, Whitlock, Evelyn, Anderson, Garnet L, Assaf, Annlouise R, and Barad, David

Subjects
Nutrition, Cancer, Physical Injury - Accidents and Adverse Effects, Aging, Osteoporosis, Clinical Trials and Supportive Activities, Clinical Research, Prevention, Complementary and Integrative Health, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Musculoskeletal, Aged, Bone Density, Calcium, Calcium Carbonate, Double-Blind Method, Drug Combinations, Drug Interactions, Estrogen Replacement Therapy, Female, Follow-Up Studies, Fractures, Bone, Hip Fractures, Humans, Kidney Calculi, Middle Aged, Patient Compliance, Postmenopause, Proportional Hazards Models, Risk, Spinal Fractures, Vitamin D, Women's Health Initiative Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThe efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal.MethodsWe recruited 36,282 postmenopausal women, 50 to 79 years of age, who were already enrolled in a Women's Health Initiative (WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental [corrected] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo. Fractures were ascertained for an average follow-up period of 7.0 years. Bone density was measured at three WHI centers.ResultsHip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P

Published
2006

22. Low-Fat Dietary Pattern and Risk of Colorectal Cancer: The Women's Health Initiative Randomized Controlled Dietary Modification Trial

Author

Beresford, Shirley AA, Johnson, Karen C, Ritenbaugh, Cheryl, Lasser, Norman L, Snetselaar, Linda G, Black, Henry R, Anderson, Garnet L, Assaf, Annlouise R, Bassford, Tamsen, Bowen, Deborah, Brunner, Robert L, Brzyski, Robert G, Caan, Bette, Chlebowski, Rowan T, Gass, Margery, Harrigan, Rosanne C, Hays, Jennifer, Heber, David, Heiss, Gerardo, Hendrix, Susan L, Howard, Barbara V, Hsia, Judith, Hubbell, F Allan, Jackson, Rebecca D, Kotchen, Jane Morley, Kuller, Lewis H, LaCroix, Andrea Z, Lane, Dorothy S, Langer, Robert D, Lewis, Cora E, Manson, JoAnn E, Margolis, Karen L, Mossavar-Rahmani, Yasmin, Ockene, Judith K, Parker, Linda M, Perri, Michael G, Phillips, Lawrence, Prentice, Ross L, Robbins, John, Rossouw, Jacques E, Sarto, Gloria E, Stefanick, Marcia L, Van Horn, Linda, Vitolins, Mara Z, Wactawski-Wende, Jean, Wallace, Robert B, and Whitlock, Evelyn

Subjects
Prevention, Aging, Clinical Trials and Supportive Activities, Clinical Research, Colo-Rectal Cancer, Complementary and Integrative Health, Nutrition, Cancer, Digestive Diseases, Prevention of disease and conditions, and promotion of well-being, 3.3 Nutrition and chemoprevention, Adenoma, Aged, Aspirin, Colonic Polyps, Colorectal Neoplasms, Diet, Fat-Restricted, Estrogen Replacement Therapy, Female, Follow-Up Studies, Humans, Incidence, Likelihood Functions, Middle Aged, Postmenopause, Primary Prevention, Proportional Hazards Models, Risk, Risk Factors, Medical and Health Sciences, General & Internal Medicine
Abstract

ContextObservational studies and polyp recurrence trials are not conclusive regarding the effects of a low-fat dietary pattern on risk of colorectal cancer, necessitating a primary prevention trial.ObjectiveTo evaluate the effects of a low-fat eating pattern on risk of colorectal cancer in postmenopausal women.Design, setting, and participantsThe Women's Health Initiative Dietary Modification Trial, a randomized controlled trial conducted in 48,835 postmenopausal women aged 50 to 79 years recruited between 1993 and 1998 from 40 clinical centers throughout the United States.InterventionsParticipants were randomly assigned to the dietary modification intervention (n = 19,541; 40%) or the comparison group (n = 29,294; 60%). The intensive behavioral modification program aimed to motivate and support reductions in dietary fat, to increase consumption of vegetables and fruits, and to increase grain servings by using group sessions, self-monitoring techniques, and other tailored and targeted strategies. Women in the comparison group continued their usual eating pattern.Main outcome measureInvasive colorectal cancer incidence.ResultsA total of 480 incident cases of invasive colorectal cancer occurred during a mean follow-up of 8.1 (SD, 1.7) years. Intervention group participants significantly reduced their percentage of energy from fat by 10.7% more than did the comparison group at 1 year, and this difference between groups was mostly maintained (8.1% at year 6). Statistically significant increases in vegetable, fruit, and grain servings were also made. Despite these dietary changes, there was no evidence that the intervention reduced the risk of invasive colorectal cancer during the follow-up period. There were 201 women with invasive colorectal cancer (0.13% per year) in the intervention group and 279 (0.12% per year) in the comparison group (hazard ratio, 1.08; 95% confidence interval, 0.90-1.29). Secondary analyses suggested potential interactions with baseline aspirin use and combined estrogen-progestin use status (P = .01 for each). Colorectal examination rates, although not protocol defined, were comparable between the intervention and comparison groups. Similar results were seen in analyses adjusting for adherence to the intervention.ConclusionIn this study, a low-fat dietary pattern intervention did not reduce the risk of colorectal cancer in postmenopausal women during 8.1 years of follow-up.Clinical trials registrationClinicalTrials.gov Identifier: NCT00000611.

Published
2006

23. Low-Fat Dietary Pattern and Risk of Cardiovascular Disease: The Women's Health Initiative Randomized Controlled Dietary Modification Trial

Author

Howard, Barbara V, Van Horn, Linda, Hsia, Judith, Manson, JoAnn E, Stefanick, Marcia L, Wassertheil-Smoller, Sylvia, Kuller, Lewis H, LaCroix, Andrea Z, Langer, Robert D, Lasser, Norman L, Lewis, Cora E, Limacher, Marian C, Margolis, Karen L, Mysiw, W Jerry, Ockene, Judith K, Parker, Linda M, Perri, Michael G, Phillips, Lawrence, Prentice, Ross L, Robbins, John, Rossouw, Jacques E, Sarto, Gloria E, Schatz, Irwin J, Snetselaar, Linda G, Stevens, Victor J, Tinker, Lesley F, Trevisan, Maurizio, Vitolins, Mara Z, Anderson, Garnet L, Assaf, Annlouise R, Bassford, Tamsen, Beresford, Shirley AA, Black, Henry R, Brunner, Robert L, Brzyski, Robert G, Caan, Bette, Chlebowski, Rowan T, Gass, Margery, Granek, Iris, Greenland, Philip, Hays, Jennifer, Heber, David, Heiss, Gerardo, Hendrix, Susan L, Hubbell, F Allan, Johnson, Karen C, and Kotchen, Jane Morley

Subjects
Clinical Research, Prevention, Nutrition, Aging, Clinical Trials and Supportive Activities, Complementary and Integrative Health, Cardiovascular, Heart Disease, Prevention of disease and conditions, and promotion of well-being, 3.3 Nutrition and chemoprevention, Stroke, Good Health and Well Being, Aged, Cardiovascular Diseases, Coronary Disease, Diet, Fat-Restricted, Energy Intake, Fatty Acids, Female, Follow-Up Studies, Humans, Incidence, Middle Aged, Outcome Assessment, Health Care, Postmenopause, Primary Prevention, Proportional Hazards Models, Risk, Risk Factors, Medical and Health Sciences, General & Internal Medicine
Abstract

ContextMultiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed.ObjectiveTo test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk.Design, setting, and participantsRandomized controlled trial of 48,835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19,541 [40%]) or comparison group (29,294 [60%]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years.InterventionIntensive behavior modification in group and individual sessions designed to reduce total fat intake to 20% of calories and increase intakes of vegetables/fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials.Main outcome measuresFatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke).ResultsBy year 6, mean fat intake decreased by 8.2% of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9%), monounsaturated (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63%), 434 (0.28%), and 1357 (0.86%) in the intervention and 1549 (0.65%), 642 (0.27%), and 2088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95% CI, 0.90-1.15), or CVD (HR, 0.98; 95% CI, 0.92-1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits.ConclusionsOver a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk.Clinical trials registrationClinicalTrials.gov Identifier: NCT00000611.

Published
2006

24. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial.

Author

Anderson, Garnet L, Limacher, Marian, Assaf, Annlouise R, Bassford, Tamsen, Beresford, Shirley AA, Black, Henry, Bonds, Denise, Brunner, Robert, Brzyski, Robert, Caan, Bette, Chlebowski, Rowan, Curb, David, Gass, Margery, Hays, Jennifer, Heiss, Gerardo, Hendrix, Susan, Howard, Barbara V, Hsia, Judith, Hubbell, Allan, Jackson, Rebecca, Johnson, Karen C, Judd, Howard, Kotchen, Jane Morley, Kuller, Lewis, LaCroix, Andrea Z, Lane, Dorothy, Langer, Robert D, Lasser, Norman, Lewis, Cora E, Manson, JoAnn, Margolis, Karen, Ockene, Judith, O'Sullivan, Mary Jo, Phillips, Lawrence, Prentice, Ross L, Ritenbaugh, Cheryl, Robbins, John, Rossouw, Jacques E, Sarto, Gloria, Stefanick, Marcia L, Van Horn, Linda, Wactawski-Wende, Jean, Wallace, Robert, Wassertheil-Smoller, Sylvia, and Women's Health Initiative Steering Committee

Subjects
Women's Health Initiative Steering Committee, Humans, Breast Neoplasms, Colorectal Neoplasms, Pulmonary Embolism, Coronary Disease, Hip Fractures, Estrogens, Conjugated (USP), Estrogens, Estrogen Replacement Therapy, Hysterectomy, Cause of Death, Proportional Hazards Models, Risk Assessment, Double-Blind Method, Postmenopause, Aged, Middle Aged, Female, Stroke, Conjugated, General & Internal Medicine, Medical and Health Sciences
Abstract

Despite decades of use and considerable research, the role of estrogen alone in preventing chronic diseases in postmenopausal women remains uncertain.To assess the effects on major disease incidence rates of the most commonly used postmenopausal hormone therapy in the United States.A randomized, double-blind, placebo-controlled disease prevention trial (the estrogen-alone component of the Women's Health Initiative [WHI]) conducted in 40 US clinical centers beginning in 1993. Enrolled were 10 739 postmenopausal women, aged 50-79 years, with prior hysterectomy, including 23% of minority race/ethnicity.Women were randomly assigned to receive either 0.625 mg/d of conjugated equine estrogen (CEE) or placebo.The primary outcome was coronary heart disease (CHD) incidence (nonfatal myocardial infarction or CHD death). Invasive breast cancer incidence was the primary safety outcome. A global index of risks and benefits, including these primary outcomes plus stroke, pulmonary embolism (PE), colorectal cancer, hip fracture, and deaths from other causes, was used for summarizing overall effects.In February 2004, after reviewing data through November 30, 2003, the National Institutes of Health (NIH) decided to end the intervention phase of the trial early. Estimated hazard ratios (HRs) (95% confidence intervals [CIs]) for CEE vs placebo for the major clinical outcomes available through February 29, 2004 (average follow-up 6.8 years), were: CHD, 0.91 (0.75-1.12) with 376 cases; breast cancer, 0.77 (0.59-1.01) with 218 cases; stroke, 1.39 (1.10-1.77) with 276 cases; PE, 1.34 (0.87-2.06) with 85 cases; colorectal cancer, 1.08 (0.75-1.55) with 119 cases; and hip fracture, 0.61 (0.41-0.91) with 102 cases. Corresponding results for composite outcomes were: total cardiovascular disease, 1.12 (1.01-1.24); total cancer, 0.93 (0.81-1.07); total fractures, 0.70 (0.63-0.79); total mortality, 1.04 (0.88-1.22), and the global index, 1.01 (0.91-1.12). For the outcomes significantly affected by CEE, there was an absolute excess risk of 12 additional strokes per 10 000 person-years and an absolute risk reduction of 6 fewer hip fractures per 10 000 person-years. The estimated excess risk for all monitored events in the global index was a nonsignificant 2 events per 10 000 person-years.The use of CEE increases the risk of stroke, decreases the risk of hip fracture, and does not affect CHD incidence in postmenopausal women with prior hysterectomy over an average of 6.8 years. A possible reduction in breast cancer risk requires further investigation. The burden of incident disease events was equivalent in the CEE and placebo groups, indicating no overall benefit. Thus, CEE should not be recommended for chronic disease prevention in postmenopausal women.

Published
2004

25. Prognostic value of chromogranin A in chronic heart failure: data from the GISSI-Heart Failure trial

Author

Røsjø H, Masson S, Latini R, Flyvbjerg A, Milani V, La Rovere MT, Revera M, Mezzani A, Tognoni G, Tavazzi L, Omland T, Moccetti T, Rossi MG, AnesiniA A, Allemano P, Reynaud SG, Fenoil R, Giannuzzi P, Corrà U, Gavazzi A, Grosu A, Volpi A, Jones KN, Lissi C, Turazza FM, Frigerio M, Febo O, Olmett F, Cirò A, Vincenzi A, Scelsi L, Campana C, Opasich C, Gualco A, Iannone MA, Cucchi G, Catania G, Tarantini L, Rigatelli G, Boni S, Carlon R, Sacchetta A, Borgese L, Sarto P, Milan S, Milan D, Roncon L, Carraro M, Rossi R, Carbonieri E, Valentini A, Brighetti G, Cantarelli A, Ferrari R, FuciliF A, Bonfiglioli A, Mariani PR, Martinelli S, Buccolieri M, Moretti L, Partemi L, Gregori G, Testa D, Pulignano G, Santini M, Varveri A, Aspromonte N, Staniscia D, Calgione E, Vetrano A, Pettinati G, Ciricugno S, Gualtieri MR, Villella M, Lauletta R, Tagliamonte E, Scozzafava A, Cassano S, Misuraca G, Caporale R, Musca G, Carpino C, Leonardi G, Ledda G, Di Tano G, Cirrincione V, Sanfilippo N, Enia F, Floresta M, Porcu M, Orrù P., PERRONE FILARDI, PASQUALE, Røsjø, H, Masson, S, Latini, R, Flyvbjerg, A, Milani, V, La Rovere, Mt, Revera, M, Mezzani, A, Tognoni, G, Tavazzi, L, Omland, T, Moccetti, T, Rossi, Mg, Anesinia, A, Allemano, P, Reynaud, Sg, Fenoil, R, Giannuzzi, P, Corrà, U, Gavazzi, A, Grosu, A, Volpi, A, Jones, Kn, Lissi, C, Turazza, Fm, Frigerio, M, Febo, O, Olmett, F, Cirò, A, Vincenzi, A, Scelsi, L, Campana, C, Opasich, C, Gualco, A, Iannone, Ma, Cucchi, G, Catania, G, Tarantini, L, Rigatelli, G, Boni, S, Carlon, R, Sacchetta, A, Borgese, L, Sarto, P, Milan, S, Milan, D, Roncon, L, Carraro, M, Rossi, R, Carbonieri, E, Valentini, A, Brighetti, G, Cantarelli, A, Ferrari, R, Fucilif, A, Bonfiglioli, A, Mariani, Pr, Martinelli, S, Buccolieri, M, Moretti, L, Partemi, L, Gregori, G, Testa, D, Pulignano, G, Santini, M, Varveri, A, Aspromonte, N, Staniscia, D, Calgione, E, Vetrano, A, PERRONE FILARDI, Pasquale, Pettinati, G, Ciricugno, S, Gualtieri, Mr, Villella, M, Lauletta, R, Tagliamonte, E, Scozzafava, A, Cassano, S, Misuraca, G, Caporale, R, Musca, G, Carpino, C, Leonardi, G, Ledda, G, Di Tano, G, Cirrincione, V, Sanfilippo, N, Enia, F, Floresta, M, Porcu, M, and Orrù, P.

Subjects
Male, endocrine system, medicine.medical_specialty, Randomization, Renal function, Gastroenterology, law.invention, Randomized controlled trial, law, Diabetes mellitus, Internal medicine, Humans, Medicine, Heart rate variability, Rosuvastatin, Aged, Aged, 80 and over, Heart Failure, biology, business.industry, Chromogranin A, Middle Aged, Prognosis, medicine.disease, Endocrinology, Heart failure, Chronic Disease, biology.protein, Female, Cardiology and Cardiovascular Medicine, business, Biomarkers, medicine.drug
Abstract

Udgivelsesdato: 2010 AIMS: To assess the association between circulating levels of chromogranin A (CgA) and outcome in a large population of patients with chronic heart failure (HF). METHODS AND RESULTS: Plasma CgA levels were measured at randomization and after 3 months in 1233 patients (median age 68 years, 80% male) with chronic, stable HF from the GISSI-HF trial. Circulating CgA levels were associated with several established risk markers in HF, including increased age, diabetes, reduced renal function, and heart rate variability. During a median follow-up of 3.9 years, 333 patients (27%) died. By univariable analysis, plasma CgA levels at baseline were strongly associated with all-cause mortality during follow-up; 2nd vs. 1st tertile: HR 1.58 (1.17-2.11), P = 0.002; and 3rd vs. 1st tertile: HR 2.35 (1.78-3.10), P < 0.0001. After adjustment for established risk factors of mortality, this association was attenuated and no longer significant. Randomized treatments with n-3 polyunsaturated fatty acid or rosuvastatin did not significantly change plasma CgA concentration over 3 months. CONCLUSION: Measurement of circulating CgA levels in patients with chronic, stable HF does not provide incremental prognostic information to that obtained from physical examination, routine biochemical analysis, and contemporary HF biomarkers.

Published
2010
Full Text
View/download PDF

26. Prevalence and prognostic value of elevated urinary albumin excretion in patients with chronic heart failure data from the GISSI-Heart failure trial

Author

Masson S, Latini R, Milani V, Moretti L, Rossi MG, Carbonieri E, Frisinghelli A, Minneci C, Valisi M, Maggioni AP, Marchioli R, Tognoni G, Tavazzi L, Roncarolo PL, Gregori G, Zanetta M, Boni S, Porcu M, Pettinati G, Ciricugno S, Caliendo L, Leonardi G, Perticone F, Raccagni D, Severini D, Carlon R, Cosmi F, Cosmi D, Misuraca G, Barbieri A, Buia E, Stella L, Malinverni C, Pende A, Caruso D, Volpi A, Jones N, Buccolieri M, Tagliamonte E, Rigatelli G, Barbiero M, Portulano V, Scillabra G, Di Tano G, Beretta L, Margonato A, Coppolino C, Sarto P, Aiolfi E, Musca G, Girardi P, Campaniello C, Lucchina PG, Montagna L, Geraci G, Floresta M, Ingrillì F, Palvarini M, Opasich C, Gualco A, Revera M, Battista R, De Risi L, Mazzucco R, Milan D, Ruggeri A, Piovaccari G, Provenzano A, Varveri A, Rossi I, Mos L, Partesana N, Cucchi G, Anastasio L, Bernardinangeli M, Proietti G, Massobrio N, Imazio M, Fenoil R, Gabasio S, Cioffi G, Ghezzi I, Barbuzzi S, Gubelli S, Giannuzzi P, Mezzani A, Graziano G, Moccetti T, Franzosi MG, Nicolosi GL, Geraci E, Scherillo M, Fabbri G, Bartolomei B, Bertoli D, Cobelli F, Fresco C, Ledda A, Levantesi G, Rusconi F, Sinagra G, Turazza F, Volpi A., PERRONE FILARDI, PASQUALE, Masson, S, Latini, R, Milani, V, Moretti, L, Rossi, Mg, Carbonieri, E, Frisinghelli, A, Minneci, C, Valisi, M, Maggioni, Ap, Marchioli, R, Tognoni, G, Tavazzi, L, Roncarolo, Pl, Gregori, G, Zanetta, M, Boni, S, Porcu, M, Pettinati, G, Ciricugno, S, Caliendo, L, Leonardi, G, Perticone, F, Raccagni, D, Severini, D, Carlon, R, Cosmi, F, Cosmi, D, Misuraca, G, Barbieri, A, Buia, E, Stella, L, Malinverni, C, Pende, A, Caruso, D, Volpi, A, Jones, N, Buccolieri, M, Tagliamonte, E, Rigatelli, G, Barbiero, M, Portulano, V, Scillabra, G, Di Tano, G, Beretta, L, Margonato, A, Coppolino, C, Sarto, P, Aiolfi, E, Musca, G, PERRONE FILARDI, Pasquale, Girardi, P, Campaniello, C, Lucchina, Pg, Montagna, L, Geraci, G, Floresta, M, Ingrillì, F, Palvarini, M, Opasich, C, Gualco, A, Revera, M, Battista, R, De Risi, L, Mazzucco, R, Milan, D, Ruggeri, A, Piovaccari, G, Provenzano, A, Varveri, A, Rossi, I, Mos, L, Partesana, N, Cucchi, G, Anastasio, L, Bernardinangeli, M, Proietti, G, Massobrio, N, Imazio, M, Fenoil, R, Gabasio, S, Cioffi, G, Ghezzi, I, Barbuzzi, S, Gubelli, S, Giannuzzi, P, Mezzani, A, Graziano, G, Moccetti, T, Franzosi, Mg, Nicolosi, Gl, Geraci, E, Scherillo, M, Fabbri, G, Bartolomei, B, Bertoli, D, Cobelli, F, Fresco, C, Ledda, A, Levantesi, G, Rusconi, F, Sinagra, G, Turazza, F, and Volpi, A.

Subjects
Male, medicine.medical_specialty, Urinary system, Urine, Kidney, Excretion, Predictive Value of Tests, Internal medicine, Diabetes mellitus, medicine, Prevalence, Humans, Albuminuria, Heart failure, Microalbuminuria, Prognosis, Aged, Chronic Disease, Female, Heart Failure, Middle Aged, Cardiology and Cardiovascular Medicine, Risk factor, Intensive care medicine, business.industry, medicine.disease, medicine.symptom, business
Abstract

Background— Increased urinary excretion of albumin is an early sign of kidney damage and a risk factor for progressive cardiovascular and renal diseases and heart failure. There is, however, only limited information on the prevalence and prognostic role of urinary albumin excretion in patients with established chronic heart failure. Methods and Results— A total of 2131 patients enrolled in 76 sites participating in the GISSI-Heart Failure trial provided a first morning spot sample of urine at any of the clinical visits scheduled in the trial to calculate the urinary albumin-to-creatinine ratio. The relation between log-transformed urinary albumin-to-creatinine ratio and all-cause mortality (428 deaths, time from urine collection to event or censoring) was evaluated with Cox multivariable models adjusted for all significant risk factors at the time of urine collection, in the study population, and in patients without diabetes or hypertension. Almost 75% of the patients had normal urinary albumin excretion, but 19.9% had microalbuminuria (30 to 299 mg/g creatinine) and 5.4% had overt albuminuria (≥300 mg/g). There was a progressive, significant increase in the adjusted rate of mortality in the study population (hazard ratio, 1.12; 95% CI, 1.05 to 1.18 per 1-U increase of log(urinary albumin-to-creatinine ratio), P =0.0002) and in the subgroup of patients without diabetes or hypertension. Randomized treatments (n-3 polyunsaturated fatty acids or rosuvastatin) had no major impact on albumin excretion. Conclusions— Independently of diabetes, hypertension, or renal function, elevated albumin excretion is a powerful prognostic marker in patients with chronic heart failure.

Published
2010

27. Regular Wine Consumption in Chronic Heart Failure: Impact on Outcomes, Quality of Life, and Circulating Biomarkers

Author

Cosmi, Franco, Di Giulio, Paola, Masson, Serge, Finzi, Andrea, Marfisi, Rosa Maria, Cosmi, Deborah, Scarano, Marco, Tognoni, Gianni, Maggioni, Aldo P., Porcu, Maurizio, Boni, Silvana, Cutrupi, Giovanni, Tavazzi, Luigi, Latini, Roberto Tavazzi, L, Tognoni, G, Barlera, S, Franzosi, Mg, Latini, R, Lucci, D, Maggioni, Ap, Marchioli, R, Nicolosi, Gl, Porcu, M, Yusuf, S, Camerini, F, Cohn, Jn, Decarli, A, Pitt, B, Sleight, P, Poole-Wilson, Pa, Geraci, E, Scherillo, M, Fabbri, G, Bartolomei, B, Bertoli, D, Cobelli, F, Fresco, C, Ledda, A, Levantesi, G, Opasich, C, Rusconi, F, Sinagra, G, Turazza, F, Volpi, A, Ceseri, M, Alongi, G, Atzori, A, Bambi, F, Bastarolo, D, Bianchini, F, Cangioli, I, Canu, V, Caporusso, C, Cenni, G, Cintelli, L, Cocchio, M, Confente, A, Fenicia, E, Friso, G, Gianfriddo, M, Grilli, G, Lazzaro, B, Lonardo, G, Luise, A, Nota, R, Orlando, M, Petrolo, R, Pierattini, C, Pierota, V, Provenzani, A, Quartuccio, V, Ragno, A, Serio, C, Spolaor, A, Tafi, A, Tellaroli, E, Ghio, S, Ghizzardi, E, Masson, S, Crociati, L, Rovere, Mt, Corra, U, Di Giulio, P, Finzi, A, Gorini, M, Gonzini, L, Milani, V, Orsini, G, Bianchini, E, Cabiddu, S, Cipressa, L, Cipressa, Ml, Di Bitetto, G, Ferri, B, Galbiati, L, Lorimer, A, Pera, C, Priami, P, Rossi, Mg, Pasotti, E, Vaghi, F, Roncarolo, P, Zunino, Mt, Matta, F, Actis, E, Gaita, F, Azzaro, G, Zanetta, M, Paino, Am, Parravicini, U, Vegis, D, Conte, R, Ferraro, P, De Bernardi, A, Morelloni, S, Fagnani, M, Lucchina, Pg, Montagna, L, Bellone, E, Sappe, D, Ferraro, F, Delucchi, M, Reynaud, Sg, Dore, M, La, A, Massobrio, N, Bo, L, Trinchero, R, Imazio, M, Brocchi, G, Nejrotti, A, Rissone, L, Gabasio, S, Zocchi, C, Randazzo, S, Crenna, A, Giannuzzi, P, Bonanomi, E, Mezzani, A, De Marchi, M, Begliuomini, G, Gianonatti, Ca, Gavazzi, A, Grosu, A, Cas, Ld, Nodari, S, Garyfallidis, P, Bertoletti, A, Bonifazi, C, Arisi, S, Mascaro, F, Fraccarollo, M, Dell, S, Sfolcini, M, Bortolini, F, Raccagni, D, Turelli, A, Santarone, M, Miglierina, E, Sormani, L, Jemoli, R, Tettamanti, F, Pirelli, S, Bianchi, C, Verde, S, Mariani, M, Ziacchi, V, Ferrazza, A, Russo, A, Bortolotti, M, Pasini, Gf, Jones, Kn, Cuzzucrea, D, Gullace, G, Carbone, C, Granata, A, De, S, Del Rosso, G, Inserra, C, Renaldini, E, Zappa, C, Moretti, M, Zanini, R, Ferrari, M, Cei, A, Lissi, C, Dovico, E, Fiorentini, C, Palermo, P, Brusoni, B, Negrini, M, Heyman, J, Danzi, Gb, Frigerio, M, Beretta, L, Sachero, A, Casazza, F, Squadroni, L, Lombardi, F, Marano, L, Margonato, A, Fragasso, G, Febo, Oc, Aiolfi, E, Olmetti, F, Grieco, A, Antonazzo, V, Specchia, G, Mortara, A, Robustelli, F, Songini, Mg, Schweiger, C, Frisinghelli, A, Palvarini, M, Campana, C, Scelsi, L, Marsan, Na, Gualco, A, De Feo, S, Iannone, Ma, Diaco, T, Zaniboni, D, Milanesi, G, Nassiacos, D, Meloni, S, Giani, P, Nicoli, T, Malinverni, C, Gusmini, A, Pozzoni, L, Bisiani, G, Margaroli, P, Schizzarotto, A, Daverio, A, Morelli, E, Occhi, G, Partesana, N, Bandini, P, Rosella, Mg, Giustiniani, S, Cucchi, G, Pedretti, R, Raimondo, R, Vaninetti, R, Fedele, A, Ghezzi, I, Rezzonico, E, Salerno, Ja, Morandi, F, Salvucci, F, Valenti, C, Graziano, G, Romano, M, Cimminiello, C, Mangone, I, Lombardo, M, Quorso, P, Marinoni, G, Breghi, M, Erckert, M, Dienstl, A, Mirante, G, Stefenelli, C, Cioffi, G, Buczkowska, E, Bonanome, A, Bazzanini, F, Parissenti, L, Serafini, C, Catania, G, Tarantini, L, Rigatelli, G, Boni, S, Pasini, A, Masini, E, Zampiero, Aa, Zanchetta, M, Franceschetto, L, Delise, P, Marcon, C, Sacchetta, A, Borgese, L, Artusi, L, Casolino, P, Corbara, F, Banzato, A, Barbiero, M, Aldegheri, Mp, Bazzucco, R, Crivellenti, G, Raviele, A, Zanella, C, Pascotto, P, Sarto, P, Milan, S, Barbieri, E, Girardi, P, Dalla, W, Mule, Jd, Di Sipio ML, Cazzin, R, Milan, D, Zonzin, P, Carraro, M, Rossi, R, Carbonieri, E, Rossi, I, Stritoni, P, Meneghetti, P, Risica, G, Tenderini, Pl, Vassanelli, C, Zanolla, L, Perini, G, Brighetti, G, Chiozza, R, Giuliano, G, Baldin, Mg, Gortan, R, Cesanelli, R, Piazza, R, Mos, L, Vriz, O, Pavan, D, Pascottini, G, Alberti, E, Werren, M, Solinas, L, Longaro, F, Fioretti, P, Albanese, Mc, Miani, D, Gianrossi, R, Pende, A, Rubartelli, P, Magaia, O, Caruso, D, Faraguti, As, Magliani, L, Miccoli, F, Guglielmino, G, Cantarelli, A, Orlandi, S, Vallebona, A, Pozzati, A, Brega, G, Pancaldi, Lg, Vandelli, R, Urbinati, S, Poci, Mg, Zoli, M, Costa, Gm, Guiducci, U, Zobbi, G, Tartagni, F, Tisselli, A, Gentili, A, Pieri, P, Cagnetta, E, Bendinelli, S, Barbieri, A, Conti, R, Ferrari, R, Merlini, F, Fucili, A, Moruzzi, P, Buia, E, Galvani, M, Ferrini, D, Baggioni, G, Yiannacopulu, P, Canè, G, Bonfiglioli, A, Zandomeneghi, R, Brugioni, L, Giannini, A, Di, R, Giuliani, M, Rusconi, L, Del Corso, P, Piovaccari, G, Bologna, F, Venturi, P, Melandri, F, Bagni, E, Bolognese, L, Perticucci, R, Zuppiroli, A, Nannini, M, Consoli, N, Petrone, P, Pipitò, C, Colombi, L, Bernardi, D, Mariani, Pr, Testa, R, Mazzinghi, F, Cosmi, F, Cosmi, D, Zipoli, A, Cecchi, A, Castelli, G, Ciaccheri, M, Mori, F, Pieri, F, Valoti, P, Chiarantini, D, Santoro, Gm, Minneci, C, Marchi, F, Milli, M, Zambaldi, G, Geri, Aa, Cipriani, M, Alessandri, M, Severi, S, Stefanelli, S, Comella, A, Poddighe, R, Digiorgio, A, Carluccio, M, Berti, S, Rizza, A, Bonatti, V, Molendi, V, Brancato, A, D'Aprile, N, Giappichini, G, Del Vecchio, S, Mantini, G, De Tommasi, F, Meucci, G, Cordoni, M, Bechi, S, Barsotti, L, Baldini, P, Romei, M, Scopelliti, G, Lauri, G, Pestelli, F, Furiozzi, F, Cocchieri, M, Severini, D, Patriarchi, F, Chiocchi, P, Buccolieri, M, Martinelli, S, Wee, A, Angelici, F, Bernardinangeli, M, Proietti, G, Biscottini, B, Panciarola, R, Marinacci, L, Perna, Gp, Gabrielli, D, Moraca, A, Moretti, L, Partemi, L, Gregori, G, Amici, R, Patteri, G, Capone, P, Savini, E, Morgagni, Gl, Paccaloni, L, Pezzuoli, F, Carincola, S, Papi, S, De Crescentini, S, Gerardi, P, Midi, P, Gallenzi, E, Pajes, G, Mancone, C, Di, V, Di Gennaro, M, Calcagno, S, Toscano, S, Antonicoli, S, Carta, F, Giorgi, G, Comito, F, Daniele, E, Goretti, Sm, Ciarla, O, Gelfo, Pg, Acquaviva, A, Testa, D, Testa, G, Pagliaro, Fa, Russo, F, Vetta, F, Marchese, I, Di, G, D'Ambrosio, A, Leggio, F, Del Sindaco, D, Lacchè, A, Avallone, A, Risa, Mp, Azzolini, P, Baldo, E, Giovannini, E, Pulignano, G, Tondo, C, Picchio, E, Biffani, E, Tanzi, P, Pozzar, F, Farnetti, F, Azzarito, M, Santini, M, Varveri, A, Ferraiuolo, G, Valtorta, C, Gaspardone, A, Barbato, G, Ceci, V, Aspromonte, N, Bellocci, F, Colizzi, C, Fedele, F, Perez, Fi, Galati, A, Rossetti, A, Mainella, A, Ciuffetta, D, Matteucci, C, Busi, G, De, A, Farina, G, Granatelli, A, Leone, F, Frasca, F, Castellani, G, Massaro, G, Mastrogiuseppe, G, Vacri, A, De Sanctis, F, Cioli, M, Di Luzio, S, Napoletano, C, Piccioni, Ll, De Simone, G, Ottaviano, A, Mazza, V, Spedaliere, C, Staniscia, Td, Calgione, E, De Marco, G, Chiacchio, T, Di, T, Romanzi, S, Salvatore, G, Golino, P, Palermo, A, Mascia, F, Vetrano, A, Vinciguerra, A, Caliendo, L, Longobardi, R, De Caro, G, Di Nola, R, Piemonte, F, Prinzi, D, De Rosa, P, De, V, Riello, F, Capuano, V, Vecchio, G, Landi, M, Amato, S, Garofalo, M, D'Avino, M, Sensale, P, Maiolica, O, Santoro, R, Caso, P, Miceli, D, Maurea, N, Bianchi, U, Crispo, C, Chiariello, M, Filardi, Pp, Russo, L, Capuano, N, Ungaro, G, Vergara, G, Scafuro, F, D'Angelo, G, Campaniello, C, Bottiglieri, P, Volpe, A, Battista, R, De Risi, L, Cardillo, G, Sibilio, G, Marino, Ap, Silvestri, F, Predotti, P, Iervoglini, A, De Matteis, C, Sarnicola, P, Matarazzo, Mm, Baldi, S, Iuliano, V, Astarita, C, Cuccaro, P, Liguori, A, Liguori, G, Gregorio, G, Petraglia, L, Antonelli, G, Amodio, G, De Luca, I, Franchini, G, Lenti, Ml, Cavallari, D, D'Agostino, C, Scalera, G, Altamura, Cm, Russo, M, Mascolo, Ar, Pettinati, G, Ciricugno, Sa, Scrutinio, D, Passantino, A, Mastrangelo, D, Di Masi, A, De, R, Cannone, M, Dibiase, F, Pensato, M, Loliva, F, Trapani, F, Panettieri, I, Leone, L, Di, M, Carrone, M, Gallone, V, Cocco, F, Costantini, M, Tritto, C, Cavalieri, F, Stella, L, Magliari, F, Callerame, M, De Giorgi, A, Pellegrino, L, Correra, M, Portulano, V, Nisi, Gl, Grassi, G, Cristallo, E, De Laura, D, Salerno, C, Fanelli, R, Villella, M, Pede, S, Renna, A, De Lorenzi, E, Urso, L, Lenti, V, Peluso, A, Baldi, N, Polimeni, G, Palma, P, Lauletta, R, Tagliamonte, E, Cirillo, T, Centonze, G, D'Alessandro, B, Truncellito, L, Mecca, D, Petruzzi, Ma, Coviello, Ro, Lopizzo, A, Chiaffitelli, M, Barbuzzi, S, Gubelli, S, Germinario, G, Cosentino, N, Mingrone, A, Vico, R, Borrello, G, Mazza, Ml, Cimino, R, Galasso, D, Cassadonte, F, Talarico, U, Perticone, F, Cassano, S, Catapano, F, Calemme, S, Feraco, E, Cloro, C, Misuraca, G, Caporale, R, Vigna, L, Spagnuolo, V, De Rosa, F, Spadafora, G, Zampaglione, G, Russo, R, Schipani, Fa, Ferragina, Af, Stranieri, D, Musca, G, Carpino, C, Bencardino, P, Raimondo, F, Musacchio, D, Pulitano, G, Ruggeri, A, Provenzano, A, Salituri, S, Musolino, M, Calandruccio, S, Marrari, A, Tripodi, E, Scali, R, Anastasio, L, Arone, A, Aragona, P, Donnangelo, L, Comito, Mg, Bilotta, F, Vaccaro, I, Rametta, R, Ventura, V, Bonvegna, A, Alì, A, Cinnirella, C, Raineri, M, Pompeo, F, Ingurgio, Nc, Carini, V, Coco, R, Giunta, G, Leonardi, G, Randazzo, V, Di Blasi, V, Tamburino, C, Russo, G, Mangiameli, S, Cardillo, R, Castelli, D, Inserra, V, Arena, A, Gulizia, Mm, Raciti, S, Rapisarda, G, Romano, R, Prestifilippo, P, Braschi, Gb, Ledda, G, Terrazzino, R, De Caro, M, Scilabra, G, Graffagnino, B, Grassi, R, Scimone, Gf, Vasquez, L, Coppolino, C, Casale, A, Castelli, M, D'Urso, G, D'Antonio, E, Presti, Ll, Badalamenti, E, Conti, P, Sanfilippo, N, Cirrincione, V, Cinà, Mt, Cusimano, G, Taormina, A, Giuliano, P, Bajardi, A, Mandala, V, Canonico, A, Geraci, G, Sabella, Fp, Enia, F, Floresta, Am, Cascio, Il, Gumina, D, Cavallaro, A, Piccione, G, Ferrante, R, Blandino, M, Iudicello, Ms, Mossuti, E, Romano, G, Lombardo, L, Monastra, P, Di Vincenzo, D, Orru, P, Muscas, F, Giardina, G, Corda, M, Locci, G, Podda, A, Ledda, M, Siddi, P, Lai, C, Pili, G, Mercuro, G, Mureddu, G, Ganau, A, Meloni, G, Poddighe, G, Sanna, G., Cosmi, Franco, Di Giulio, Paola, Masson, Serge, Finzi, Andrea, Marfisi, Rosa Maria, Cosmi, Deborah, Scarano, Marco, Tognoni, Gianni, Maggioni, Aldo P, Porcu, Maurizio, Boni, Silvana, Cutrupi, Giovanni, Tavazzi, Luigi, Latini, Roberto, on behalf of the GISSI-HF, Investigator, Margonato, Alberto, DI GIULIO, Paola, Maggioni, Aldo P., GISSI HF, Investigator, and Sinagra, Gianfranco

Subjects
Male, Health Status, Left, Wine, Comorbidity, Ventricular Function, Left, Health Statu, Quality of life, Risk Factors, Surveys and Questionnaires, Prevalence, Ventricular Function, Surveys and Questionnaire, Depression (differential diagnoses), Depression, Medicine (all), Middle Aged, Prognosis, biological marker, Italy, Female, Risk assessment, Cardiology and Cardiovascular Medicine, biological markers, Human, Cardiac function curve, Vasculitis, medicine.medical_specialty, Vasculiti, Alcohol Drinking, Prognosi, Lower risk, Risk Assessment, Internal medicine, medicine, Humans, Protective Factor, Aged, Heart Failure, business.industry, Risk Factor, Stroke Volume, Biomarker, quality of life, wine, aged, alcohol drinking, biomarkers, chronic disease, comorbidity, depression, female, heart failure, humans, italy, male, middle aged, prevalence, prognosis, protective factors, risk assessment, risk factors, stroke volume, surveys and questionnaires, vasculitis, ventricular function, left, health status, cardiology and cardiovascular medicine, Biomarkers, Chronic Disease, Protective Factors, Quality of Life, medicine.disease, Clinical trial, Heart failure, Physical therapy, business
Abstract

Background— Moderate, regular alcohol consumption is generally associated with a lower risk of cardiovascular events but data in patients with chronic heart failure are scarce. We evaluated the relations between wine consumption, health status, circulating biomarkers, and clinical outcomes in a large Italian population of patients with chronic heart failure enrolled in a multicenter clinical trial. Methods and Results— A brief questionnaire on dietary habits was administered at baseline to 6973 patients enrolled in the Gruppo Italiano per lo Studio della Sopravvivenza nell’Insufficienza Cardiaca-Heart Failure (GISSI-HF) trial. The relations between wine consumption, fatal and nonfatal clinical end points, quality of life, symptoms of depression, and circulating biomarkers of cardiac function and inflammation (in subsets of patients) were evaluated with simple and multivariable-adjusted statistical models. Almost 56% of the patients reported drinking at least 1 glass of wine per day. After adjustment, clinical outcomes were not significantly different in the predefined 4 groups of wine consumption. However, patients with more frequent wine consumption had a significantly better perception of health status (Kansas City Cardiomyopathy Questionnaire score, adjusted P P =0.01), and lower plasma levels of biomarkers of vascular inflammation (osteoprotegerin and C-terminal proendothelin-1, adjusted P P =0.01) after adjusting for possible confounders. Conclusions— We show for the first time in a large cohort of patients with chronic heart failure that moderate wine consumption is associated with a better perceived and objective health status, lower prevalence of depression, and less vascular inflammation, but does not translate into more favorable clinical 4-year outcomes. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT0033633.

Published
2015

28. External validation of the Simplified Acute Physiology Score (SAPS) 3 in a cohort of 28,357 patients from 147 Italian intensive care units

Author

Poole, D, Rossi, C, Anghileri, A, Giardino, M, Latronico, N, Radrizzani, D, Langer, M, Bertolini, G, Acciarri, C, Acquarolo, A, Adorni, A, Alberti, A, Alborghetti, A, Antonini, B, Archi, D, Arditi, E, Badii, F, Balata, A, Barattini, M, Barbagli, R, Barbieri, P, Baroncia, M, Bartoccini, A, Bartoli, T, Bassi, F, Beck, E, Bellato, V, Bellorini, M, Belluomo Anello, C, Benanti, C, Berardino, M, Bernasconi, Mo, Besozzi, A, Bianchin, A, Bindi, Ml, Biolino, P, Blasetti, A, Boccalatte, D, Bonaccorso, G, Bonfà, A, Bonfiglio, M, Boniotti, C, Bonizzoli, M, Bottari, V, Breschi, C, Brunori, E, Buonanno, R, Buzzetti, V, Calicchio, G, Calva, S, Capannolo, B, Caracciolo, A, Carnevale, L, Carsana, C, Casadei, E, Casagli, S, Casagrande, L, Casalini, P, Castiglione, G, Cavallo, R, Chiarello, M, Chieregato, A, Chinelli, E, Cigada, M, Coaloa, M, Colombo, R, Colombo, S, Corsini, W, Corvi, D, Cosentino, E, Costa, R, Costanzo, E, Cottignoli, T, Crema, L, Crestan, E, Da Re, D, Dal Cero, P, Dal Ferro, M, David, Antonio, De Blasi RA, De Blasio, E, De Luca, A, De Negri, P, Dei Poli, M, Del Sarto, P, Di Lorenzo, G, Di Masi, P, Di Pasquale, D, Di Serafino, G, Donato, I, Fabbri, L, Fabbri, E, Fabbri, Pg, Fabi, Mc, Faccio, L, Ferla, F, Ferri, F, Fiore, G, Fognani, G, Galeotti, E, Gamberini, E, Garelli, A, Garofalo, G, Garzilli, T, Giacopuzzi, L, Gianni, M, Giannoni, S, Giugiaro, Pm, Gorietti, A, Grassi, P, Greco, M, Guadagnucci, A, Guagliardi, C, Isetta, M, Lapolla, A, Lefons, U, Livigni, S, Madonna, R, Maestrone, C, Magatti, Mf, Maggiolo, C, Malacarne, P, Mancosu, S, Mangani, Va, Mantovani, G, Marafon, S, Martinez Escobar, R, Mastroianni, A, Mastropierro, R, Meloni, A, Messina, M, Miglioranzi, R, Molino, Fm, Morigi, A, Mosca, C, Murri, V, Nardi, G, Nascimben, E, Natalini, G, Negri, G, Negro, G, Neri, M, Nicolini, A, Nuovo, D, Odetto, L, Olivieri, C, Ortoleva, A, Pacini, Dm, Paganini, G, Paganoni, G, Palmer, M, Papiri, S, Parma, A, Parrini, V, Pastorelli, M, Pastorini, S, Pegoraro, M, Pezzi, A, Pinciroli, D, Piredda, G, Piva, S, Pizzaballa, M, Possamai, C, Postiglione, M, Potalivo, A, Pulici, M, Quattrocchi, P, Raffaeli, M, Ranzini, L, Righini, E, Rona, R, Rossi, G, Rossi, S, Rossi, M, Rottoli, F, Salcuni, R, Salvi, G, Savioli, M, Scarrone, S, Schellino, Mm, Segala, V, Segalini, Pa, Sera, G, Sforza, D, Sicignano, A, Sorbara, C, Spadini, E, Staccioli, P, Stefani, M, Sucre, Mj, Tartari, S, Tavola, M, Tetamo, R, Tibaldi, G, Tinacci, S, Todesco, L, Torta, M, Tosi, L, Tripepi, C, Ughi, L, Vaj, M, Vecchiarelli, P, Vespignani, Mg, Visconti, Mg, Vulcano, Ga, Zappa, S, Zocaro, R, and Zuccaro, F.

Subjects
Male, medicine.medical_specialty, Time Factors, genetic structures, Critical Care, Critical Illness, Critical Care and Intensive Care Medicine, law.invention, Bias, law, Predictive Value of Tests, Risk Factors, Intensive care, Anesthesiology, Outcome Assessment, Health Care, medicine, Humans, Hospital Mortality, Prospective Studies, Simplified Acute Physiology Score, Intensive care medicine, Prospective cohort study, Diagnosis-Related Groups, APACHE, Aged, Chi-Square Distribution, business.industry, Data Collection, Benchmarking, Critical care, Hospital mortality, Outcome assessment, Validation study, Discriminant Analysis, Middle Aged, Prognosis, Intensive care unit, Intensive Care Units, Logistic Models, Italy, ROC Curve, Predictive value of tests, Cohort, Calibration, Female, business, Chi-squared distribution
Abstract

To evaluate the SAPS 3 score predictive ability of hospital mortality in a large external validation cohort.Prospective observational study.A total of 28,357 patients from 147 Italian ICUs joining the Project Margherita national database of the Gruppo italiano per la Valutazione degli interventi in Terapia Intensiva (GiViTI).None.Evaluation of discrimination through ROC analysis and of overall goodness-of-fit through the Cox calibration test.Although discrimination was good, calibration turned out to be poor. The general and the South-Europe Mediterranean countries equations overestimated hospital mortality overall (SMR values 0.73 with 95% CI 0.72-0.75 for both equations) and homogeneously across risk classes. Overprediction was confirmed among important subgroups, with SMR values ranging between 0.47 and 0.82.The result strictly supported by our data is that the SAPS 3 score calibrates inadequately in a large sample of Italian ICU patients and thus should not be used for benchmarking, at least in Italian settings.

Published
2009

29. Prognostic Impact of Diabetes and Prediabetes on Survival Outcomes in Patients With Chronic Heart Failure: A Post-Hoc Analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) Trial

Author

Marco Dauriz, Giovanni Targher, Pier Luigi Temporelli, Donata Lucci, Lucio Gonzini, Gian Luigi Nicolosi, Roberto Marchioli, Gianni Tognoni, Roberto Latini, Franco Cosmi, Luigi Tavazzi, Aldo Pietro Maggioni, Simona Barlera, Maria Grazia Franzosi, Aldo P. Maggioni, Maurizio Porcu, Salim Yusuf, Fulvio Camerini, Jay N. Cohn, Adriano Decarli, Bertram Pitt, Peter Sleight, Philip A. Poole‐Wilson, Enrico Geraci, Marino Scherillo, Gianna Fabbri, Barbara Bartolomei, Daniele Bertoli, Franco Cobelli, Claudio Fresco, Antonietta Ledda, Giacomo Levantesi, Cristina Opasich, Franco Rusconi, Gianfranco Sinagra, Fabio Turazza, Alberto Volpi, Martina Ceseri, Gianluca Alongi, Antonio Atzori, Filippo Bambi, Desiree Bastarolo, Francesca Bianchini, Iacopo Cangioli, Vittoriana Canu, Concetta Caporusso, Gabriele Cenni, Laura Cintelli, Michele Cocchio, Alessia Confente, Eva Fenicia, Giorgio Friso, Marco Gianfriddo, Gianluca Grilli, Beatrice Lazzaro, Giuseppe Lonardo, Alessia Luise, Rachele Nota, Mariaelena Orlando, Rosaria Petrolo, Chiara Pierattini, Valeria Pierota, Alessandro Provenzani, Velia Quartuccio, Anna Ragno, Chiara Serio, Alvise Spolaor, Arianna Tafi, Elisa Tellaroli, Stefano Ghio, Elisa Ghizzardi, Serge Masson, Lella Crociati, Maria Teresa La Rovere, Ugo Corrà, Andrea Finzi, Marco Gorini, Valentina Milani, Giampietro Orsini, Elisa Bianchini, Silvia Cabiddu, Ilaria Cangioli, Laura Cipressa, Maria Lucia Cipressa, Giuseppina Di Bitetto, Barbara Ferri, Luisa Galbiati, Andrea Lorimer, Carla Pera, Paola Priami, Antonella Vasamì, T. Moccetti, M.G. Rossi, E. Pasotti, F. Vaghi, P. Roncarolo, M.T. Zunino, F. Matta, E. Actis Perinetto, F. Gaita, G. Azzaro, M. Zanetta, A.M. Paino, U. Parravicini, D. Vegis, R. Conte, P. Ferraro, A. De Bernardi, S. Morelloni, M. Fagnani, P. Greco Lucchina, L. Montagna, E. Bellone, D. Sappè, F. Ferraro, M. Delucchi, S.G. Reynaud, M. Dore, A. La Brocca, N. Massobrio, L. Bo, R. Trinchero, M. Imazio, G. Brocchi, A. Nejrotti, L. Rissone, S. Gabasio, C. Zocchi, S. Randazzo, A. Crenna, P. Giannuzzi, E. Bonanomi, A. Mezzani, M. De Marchi, G. Begliuomini, C.A. Gianonatti, A. Gavazzi, A. Grosu, L. Dei Cas, S. Nodari, P. Garyfallidis, A. Bertoletti, C. Bonifazi, S. Arisi, F. Mascaro, M. Fraccarollo, S. Dell'Orto, M. Sfolcini, F. Bortolini, D. Raccagni, A. Turelli, M. Santarone, E. Miglierina, L. Sormani, R. Jemoli, F. Tettamanti, S. Pirelli, C. Bianchi, S. Verde, M. Mariani, V. Ziacchi, A. Ferrazza, A. Russo, M. Bortolotti, G.F. Pasini, A. Volpi, K.N. Jones, D. Cuzzucrea, G. Gullace, C. Carbone, A. Granata, S. De Servi, G. Del Rosso, C. Inserra, E. Renaldini, C. Zappa, M. Moretti, R. Zanini, M. Ferrari, E. Moroni, A. Cei, C. Lissi, E. Dovico, C. Fiorentini, P. Palermo, B. Brusoni, M. Negrini, J. Heyman, G.B. Danzi, A. Finzi, M. Frigerio, F. Turazza, L. Beretta, A. Sachero, F. Casazza, L. Squadroni, F. Lombardi, L. Marano, A. Margonato, G. Fragasso, O.C. Febo, E. Aiolfi, F. Olmetti, A. Grieco, V. Antonazzo, G. Specchia, A. Mortara, F. Robustelli, M.G. Songini, C. Schweiger, A. Frisinghelli, M. Palvarini, C. Campana, L. Scelsi, N. Ajmone Marsan, F. Cobelli, A. Gualco, C. Opasich, S. De Feo, R. Mazzucco, M.A. Iannone, T. Diaco, D. Zaniboni, G. Milanesi, D. Nassiacos, S. Meloni, P. Giani, T. Nicoli, C. Malinverni, A. Gusmini, L. Pozzoni, G. Bisiani, P. Margaroli, A. Schizzarotto, A. Daverio, G. Occhi, N. Partesana, P. Bandini, M.G. Rosella, S. Giustiniani, G. Cucchi, R. Pedretti, R. Raimondo, R. Vaninetti, A. Fedele, I. Ghezzi, E. Rezzonico, J.A. Salerno Uriarte, F. Morandi, F. Salvucci, C. Valenti, G. Graziano, M. Romanò, C. Cimminiello, I. Mangone, M. Lombardo, P. Quorso, G. Marinoni, M. Breghi, M. Erckert, A. Dienstl, G. Mirante Marini, C. Stefenelli, G. Cioffi, E. Buczkowska, A. Bonanome, F. Bazzanini, L. Parissenti, C. Serafini, G. Catania, L. Tarantini, G. Rigatelli, S. Boni, A. Pasini, E. Masini, A.A. Zampiero, M. Zanchetta, L. Franceschetto, P. Delise, C. Marcon, A. Sacchetta, L. Borgese, L. Artusi, P. Casolino, F. Corbara, A. Banzato, M. Barbiero, M.P. Aldegheri, R. Bazzucco, G. Crivellenti, A. Raviele, C. Zanella, P. Pascotto, P. Sarto, S. Milan, E. Barbieri, P. Girardi, W. Dalla Villa, J. Dalle Mule, M.L. Di Sipio, R. Cazzin, D. Milan, P. Zonzin, M. Carraro, R. Rossi, E. Carbonieri, I. Rossi, P. Stritoni, P. Meneghetti, G. Risica, P.L. Tenderini, C. Vassanelli, L. Zanolla, G. Perini, G. Brighetti, R. Chiozza, G. Giuliano, R. Gortan, R. Cesanelli, G.L. Nicolosi, R. Piazza, L. Mos, O. Vriz, D. Pavan, G. Pascottini, E. Alberti, M. Werren, L. Solinas, G. Sinagra, F. Longaro, P. Fioretti, M.C. Albanese, D. Miani, R. Gianrossi, A. Pende, P. Rubartelli, O. Magaia, S. Domenicucci, D. Caruso, A.S. Faraguti, L. Magliani, F. Miccoli, G. Guglielmino, D. Bertoli, A. Cantarelli, S. Orlandi, A. Vallebona, A. Pozzati, G. Brega, L.G. Pancaldi, R. Vandelli, S. Urbinati, M.G. Poci, M. Zoli, G.M. Costa, U. Guiducci, G. Zobbi, F. Tartagni, A. Tisselli, A. Gentili, P. Pieri, E. Cagnetta, S. Bendinelli, A. Barbieri, R. Conti, R. Ferrari, F. Merlini, A. Fucili, P. Moruzzi, E. Buia, M. Galvani, D. Ferrini, G. Baggioni, P. Yiannacopulu, G. Canè, A. Bonfiglioli, R. Zandomeneghi, L. Brugioni, A. Giannini, R. Di Ruvo, M. Giuliani, L. Rusconi, P. Del Corso, G. Piovaccari, F. Bologna, P. Venturi, F. Melandri, E. Bagni, L. Bolognese, R. Perticucci, A. Zuppiroli, M. Nannini, N. Consoli, P. Petrone, C. Pipitò, L. Colombi, D. Bernardi, P.R. Mariani, R. Testa, F. Mazzinghi, F. Cosmi, D. Cosmi, A. Zipoli, A. Cecchi, G. Castelli, M. Ciaccheri, F. Mori, F. Pieri, P. Valoti, D. Chiarantini, G.M. Santoro, C. Minneci, F. Marchi, M. Milli, G. Zambaldi, A.A. Brandinelli Geri, M. Cipriani, M. Alessandri, S. Severi, S. Stefanelli, A. Comella, R. Poddighe, A. Digiorgio, M. Carluccio, S. Berti, A. Rizza, V. Bonatti, V. Molendi, A. Brancato, N. D'Aprile, G. Giappichini, S. Del Vecchio, G. Mantini, F. De Tommasi, G. Meucci, M. Cordoni, S. Bechi, L. Barsotti, P. Baldini, M. Romei, G. Scopelliti, G. Lauri, F. Pestelli, F. Furiozzi, M. Cocchieri, D. Severini, F. Patriarchi, P. Chiocchi, M. Buccolieri, S. Martinelli, A. Wee, F. Angelici, M. Bernardinangeli, G. Proietti, B. Biscottini, R. Panciarola, L. Marinacci, G.P. Perna, D. Gabrielli, A. Moraca, L. Moretti, L. Partemi, G. Gregori, R. Amici, G. Patteri, P. Capone, E. Savini, G.L. Morgagni, L. Paccaloni, F. Pezzuoli, S. Carincola, S. Papi, S. De Crescentini, P. Gerardi, P. Midi, E. Gallenzi, G. Pajes, C. Mancone, V. Di Spirito, M. Di Gennaro, S. Calcagno, S. Toscano, S. Antonicoli, F. Carta, G. Giorgi, F. Comito, E. Daniele, O. Ciarla, P.G. Gelfo, A. Acquaviva, D. Testa, G. Testa, F.A. Pagliaro, F. Russo, F. Vetta, I. Marchese, G. Di Sciascio, A. D'Ambrosio, F. Leggio, D. Del Sindaco, A. Lacchè, A. Avallone, M.P. Risa, P. Azzolini, E. Baldo, E. Giovannini, G. Pulignano, C. Tondo, E. Picchio, E. ani, P. Tanzi, F. Pozzar, F. Farnetti, M. Azzarito, M. Santini, A. Varveri, G. Ferraiuolo, C. Valtorta, A. Gaspardone, G. Barbato, V. Ceci, N. Aspromonte, F. Bellocci, C. Colizzi, F. Fedele, F.I. Perez, A. Galati, A. Rossetti, A. Mainella, D. etta, C. Matteucci, G. Busi, A. De Angelis, G. Farina, A. Granatelli, F. Leone, F. Frasca, R. Di Giovambattista, G. Castellani, G. Massaro, G. Mastrogiuseppe, A. Vacri, F. De Sanctis, M. Cioli, S. Di Luzio, C. Napoletano, L.L. Piccioni, G. De Simone, A. Ottaviano, V. Mazza, C. Spedaliere, D. Staniscia, E. Calgione, G. De Marco, T. Chiacchio, T. Di Napoli, S. Romanzi, G. Salvatore, P. Golino, A. Palermo, F. Mascia, A. Vetrano, A. Vinciguerra, L. Caliendo, R. Longobardi, G. De Caro, R. Di Nola, F. Piemonte, D. Prinzi, P. De Rosa, V. De Rosa, F. Riello, V. Capuano, G. Vecchio, M. Landi, S. Amato, M. Garofalo, M. D'Avino, P. Sensale, O. Maiolica, R. Santoro, P. Caso, D. Miceli, N. Maurea, U. Bianchi, C. Crispo, M. Chiariello, P. Perrone Filardi, L. Russo, N. Capuano, G. Ungaro, G. Vergara, F. Scafuro, G. D'Angelo, C. Campaniello, P. Bottiglieri, A. Volpe, R. Battista, L. De Risi, G. Cardillo, G. Sibilio, A.P. Marino, F. Silvestri, P. Predotti, A. Iervoglini, C. De Matteis, P. Sarnicola, M.M. Matarazzo, S. Baldi, V. Iuliano, C. Astarita, P. Cuccaro, A. Liguori, G. Liguori, G. Gregorio, L. Petraglia, G. Antonelli, G. Amodio, I. De Luca, D. Traversa, G. Franchini, M.L. Lenti, D. Cavallari, C. D'Agostino, G. Scalera, C.M. Altamura, M. Russo, A.R. Mascolo, G. Pettinati, S.A. Ciricugno, D. Scrutinio, A. Passantino, D. Mastrangelo, A. Di Masi, R. De Carne, M. Cannone, F. Dibiase, M. Pensato, F. Loliva, F. Trapani, I. Panettieri, L. Leone, M. Di Biase, M. Carrone, V. Gallone, F. Cocco, M. Costantini, C. Tritto, F. Cavalieri, L. Stella, F. Magliari, M. Callerame, A. De Giorgi, L. Pellegrino, M. Correra, V. Portulano, G.L. Nisi, G. Grassi, E. Cristallo, D. De Laura, C. Salerno, R. Fanelli, M. Villella, S. Pede, A. Renna, E. De Lorenzi, L. Urso, V. Lenti, A. Peluso, N. Baldi, G. Polimeni, P. Palma, R. Lauletta, E. Tagliamonte, T. Cirillo, B. Silvestri, G. Centonze, B. D'Alessandro, L. Truncellito, D. Mecca, M.A. Petruzzi, R.O.M. Coviello, A. Lopizzo, M. telli, S. Barbuzzi, S. Gubelli, G. Germinario, N. Cosentino, A. Mingrone, R. Vico, G. Borrello, M.L. Mazza, R. Cimino, D. Galasso, F. Cassadonte, U. Talarico, F. Perticone, S. Cassano, F. Catapano, S. Calemme, E. Feraco, C. Cloro, G. Misuraca, R. Caporale, L. Vigna, V. Spagnuolo, F. De Rosa, G. Spadafora, G. Zampaglione, R. Russo, F.A. Schipani, A.F. Ferragina, D. Stranieri, G. Musca, C. Carpino, P. Bencardino, F. Raimondo, D. Musacchio, G. Pulitanò, A. Ruggeri, A. Provenzano, S. Salituri, M. Musolino, S. Calandruccio, A. Marrari, E. Tripodi, R. Scali, L. Anastasio, A. Arone, P. Aragona, L. Donnangelo, M.G.A. Comito, F. Bilotta, I. Vaccaro, R. Rametta, V. Ventura, A. Bonvegna, A. Alì, C. Cinnirella, M. Raineri, F. Pompeo, N. Cascio Ingurgio, V. Carini, R. Coco, G. Giunta, G. Leonardi, V. Randazzo, V. Di Blasi, C. Tamburino, G. Russo, S. Mangiameli, R. Cardillo, D. Castelli, V. Inserra, A. Arena, M.M. Gulizia, S. Raciti, G. Rapisarda, R. Romano, P. Prestifilippo, G.B. Braschi, G. Ledda, R. Terrazzino, M. De Caro, G. Scilabra, B. agnino, R. Grassi, G. Di Tano, G.F. Scimone, L. Vasquez, C. Coppolino, A. Casale, M. Castelli, G. D'Urso, E. D'Antonio, L. Lo Presti, E. Badalamenti, P. Conti, N. Sanfilippo, V. Cirrincione, M.T. Cinà, G. Cusimano, A. Taormina, P. Giuliano, A. Bajardi, V. Mandalà, A. Canonico, G. Geraci, F.P. Sabella, F. Enia, A.M. Floresta, I. Lo Cascio, D. Gumina, A. Cavallaro, G. Piccione, R. Ferrante, M. Blandino, M.S. Iudicello, E. Mossuti, G. Romano, L. Lombardo, P. Monastra, D. Di Vincenzo, M. Porcu, P. Orrù, F. Muscas, G. Giardina, M. Corda, G. Locci, A. Podda, M. Ledda, P. Siddi, C. Lai, G. Pili, G. Mercuro, G. Mureddu, A. Ganau, G. Meloni, G. Poddighe, G. Sanna, Dauriz, Marco, Targher, Giovanni, Temporelli, Pier Luigi, Lucci, Donata, Gonzini, Lucio, Nicolosi, Gian Luigi, Marchioli, Roberto, Tognoni, Gianni, Latini, Roberto, Cosmi, Franco, Tavazzi, Luigi, Maggioni, Aldo Pietro, on behalf of the GISSI-HF, Investigator, Margonato, Alberto, Moccetti, T., Rossi, M. G., Pasotti, E., Vaghi, F., Roncarolo, P., Zunino, M. T., Matta, F., Actis Perinetto, E., Gaita, F., Azzaro, G., Zanetta, M., Paino, A. M., Parravicini, U., Vegis, D., Conte, R., Ferraro, P., De Bernardi, A., Morelloni, S., Fagnani, M., Greco Lucchina, P., Montagna, L., Bellone, E., Sappè, D., Ferraro, F., Delucchi, M., Reynaud, S. G., Dore, M., La Brocca, A., Massobrio, N., Bo, L., Trinchero, R., Imazio, M., Brocchi, G., Nejrotti, A., Rissone, L., Gabasio, S., Zocchi, C., Randazzo, S., Crenna, A., Giannuzzi, P., Bonanomi, E., Mezzani, A., De Marchi, M., Begliuomini, G., Gianonatti, C. A., Gavazzi, A., Grosu, A., Dei Cas, L., Nodari, S., Garyfallidis, P., Bertoletti, A., Bonifazi, C., Arisi, S., Mascaro, F., Fraccarollo, M., Dell'Orto, S., Sfolcini, M., Bortolini, F., Raccagni, D., Turelli, A., Santarone, M., Miglierina, E., Sormani, L., Jemoli, R., Tettamanti, F., Pirelli, S., Bianchi, C., Verde, S., Mariani, M., Ziacchi, V., Ferrazza, A., Russo, A., Bortolotti, M., Pasini, G. F., Volpi, A., Jones, K. N., Cuzzucrea, D., Gullace, G., Carbone, C., Granata, A., De Servi, S., Del Rosso, G., Inserra, C., Renaldini, E., Zappa, C., Moretti, M., Zanini, R., Ferrari, M., Moroni, E., Cei, A., Lissi, C., Dovico, E., Fiorentini, C., Palermo, P., Brusoni, B., Negrini, M., Heyman, J., Danzi, G. B., Finzi, A., Frigerio, M., Turazza, F., Beretta, L., Sachero, A., Casazza, F., Squadroni, L., Lombardi, F., Marano, L., Margonato, A., Fragasso, G., Febo, O. C., Aiolfi, E., Olmetti, F., Grieco, A., Antonazzo, V., Specchia, G., Mortara, A., Robustelli, F., Songini, M. G., Schweiger, C., Frisinghelli, A., Palvarini, M., Campana, C., Scelsi, L., Ajmone Marsan, N., Cobelli, F., Gualco, A., Opasich, C., De Feo, S., Mazzucco, R., Iannone, M. A., Diaco, T., Zaniboni, D., Milanesi, G., Nassiacos, D., Meloni, S., Giani, P., Nicoli, T., Malinverni, C., Gusmini, A., Pozzoni, L., Bisiani, G., Margaroli, P., Schizzarotto, A., Daverio, A., Occhi, G., Partesana, N., Bandini, P., Rosella, M. G., Giustiniani, S., Cucchi, G., Pedretti, R., Raimondo, R., Vaninetti, R., Fedele, A., Ghezzi, I., Rezzonico, E., Salerno Uriarte, J. A., Morandi, F., Salvucci, F., Valenti, C., Graziano, G., Romanò, M., Cimminiello, C., Mangone, I., Lombardo, M., Quorso, P., Marinoni, G., Breghi, M., Erckert, M., Dienstl, A., Mirante Marini, G., Stefenelli, C., Cioffi, G., Buczkowska, E., Bonanome, A., Bazzanini, F., Parissenti, L., Serafini, C., Catania, G., Tarantini, L., Rigatelli, G., Boni, S., Pasini, A., Masini, E., Zampiero, A. A., Zanchetta, M., Franceschetto, L., Delise, P., Marcon, C., Sacchetta, A., Borgese, L., Artusi, L., Casolino, P., Corbara, F., Banzato, A., Barbiero, M., Aldegheri, M. P., Bazzucco, R., Crivellenti, G., Raviele, A., Zanella, C., Pascotto, P., Sarto, P., Milan, S., Barbieri, E., Girardi, P., Dalla Villa, W., Dalle Mule, J., Di Sipio, M. L., Cazzin, R., Milan, D., Zonzin, P., Carraro, M., Rossi, R., Carbonieri, E., Rossi, I., Stritoni, P., Meneghetti, P., Risica, G., Tenderini, P. L., Vassanelli, C., Zanolla, L., Perini, G., Brighetti, G., Chiozza, R., Giuliano, G., Baldin, M. G., Gortan, R., Cesanelli, R., Nicolosi, G. L., Piazza, R., Mos, L., Vriz, O., Pavan, D., Pascottini, G., Alberti, E., Werren, M., Solinas, L., Sinagra, G., Longaro, F., Fioretti, P., Albanese, M. C., Miani, D., Gianrossi, R., Pende, A., Rubartelli, P., Magaia, O., Domenicucci, S., Caruso, D., Faraguti, A. S., Magliani, L., Miccoli, F., Guglielmino, G., Bertoli, D., Cantarelli, A., Orlandi, S., Vallebona, A., Pozzati, A., Brega, G., Pancaldi, L. G., Vandelli, R., Urbinati, S., Poci, M. G., Zoli, M., Costa, G. M., Guiducci, U., Zobbi, G., Tartagni, F., Tisselli, A., Gentili, A., Pieri, P., Cagnetta, E., Bendinelli, S., Barbieri, A., Conti, R., Ferrari, R., Merlini, F., Fucili, A., Moruzzi, P., Buia, E., Galvani, M., Ferrini, D., Baggioni, G., Yiannacopulu, P., Canè, G., Bonfiglioli, A., Zandomeneghi, R., Brugioni, L., Giannini, A., Di Ruvo, R., Giuliani, M., Rusconi, L., Del Corso, P., Piovaccari, G., Bologna, F., Venturi, P., Melandri, F., Bagni, E., Bolognese, L., Perticucci, R., Zuppiroli, A., Nannini, M., Consoli, N., Petrone, P., Pipitò, C., Colombi, L., Bernardi, D., Mariani, P. R., Testa, R., Mazzinghi, F., Cosmi, F., Cosmi, D., Zipoli, A., Cecchi, A., Castelli, G., Ciaccheri, M., Mori, F., Pieri, F., Valoti, P., Chiarantini, D., Santoro, G. M., Minneci, C., Marchi, F., Milli, M., Zambaldi, G., Brandinelli Geri, A. A., Cipriani, M., Alessandri, M., Severi, S., Stefanelli, S., Comella, A., Poddighe, R., Digiorgio, A., Carluccio, M., Berti, S., Rizza, A., Bonatti, V., Molendi, V., Brancato, A., D'Aprile, N., Giappichini, G., Del Vecchio, S., Mantini, G., De Tommasi, F., Meucci, G., Cordoni, M., Bechi, S., Barsotti, L., Baldini, P., Romei, M., Scopelliti, G., Lauri, G., Pestelli, F., Furiozzi, F., Cocchieri, M., Severini, D., Patriarchi, F., Chiocchi, P., Buccolieri, M., Martinelli, S., Wee, A., Angelici, F., Bernardinangeli, M., Proietti, G., Biscottini, B., Panciarola, R., Marinacci, L., Perna, G. P., Gabrielli, D., Moraca, A., Moretti, L., Partemi, L., Gregori, G., Amici, R., Patteri, G., Capone, P., Savini, E., Morgagni, G. L., Paccaloni, L., Pezzuoli, F., Carincola, S., Papi, S., De Crescentini, S., Gerardi, P., Midi, P., Gallenzi, E., Pajes, G., Mancone, C., Di Spirito, V., Di Gennaro, M., Calcagno, S., Toscano, S., Antonicoli, S., Carta, F., Giorgi, G., Comito, F., Daniele, E., Ciarla, O., Gelfo, P. G., Acquaviva, A., Testa, D., Testa, G., Pagliaro, F. A., Russo, F., Vetta, F., Marchese, I., Di Sciascio, G., D'Ambrosio, A., Leggio, F., Del Sindaco, D., Lacchè, A., Avallone, A., Risa, M. P., Azzolini, P., Baldo, E., Giovannini, E., Pulignano, G., Tondo, C., Picchio, E., Biffani, E., Tanzi, P., Pozzar, F., Farnetti, F., Azzarito, M., Santini, M., Varveri, A., Ferraiuolo, G., Valtorta, C., Gaspardone, A., Barbato, G., Ceci, V., Aspromonte, N., Bellocci, F., Colizzi, C., Fedele, F., Perez, F. I., Galati, A., Rossetti, A., Mainella, A., Ciuffetta, D., Matteucci, C., Busi, G., De Angelis, A., Farina, G., Granatelli, A., Leone, F., Frasca, F., Di Giovambattista, R., Castellani, G., Massaro, G., Mastrogiuseppe, G., Vacri, A., De Sanctis, F., Cioli, M., Di Luzio, S., Napoletano, C., Piccioni, L. L., De Simone, G., Ottaviano, A., Mazza, V., Spedaliere, C., Staniscia, D., Calgione, E., De Marco, G., Chiacchio, T., Di Napoli, T., Romanzi, S., Salvatore, G., Golino, P., Palermo, A., Mascia, F., Vetrano, A., Vinciguerra, A., Caliendo, L., Longobardi, R., De Caro, G., Di Nola, R., Piemonte, F., Prinzi, D., De Rosa, P., De Rosa, V., Riello, F., Capuano, V., Vecchio, G., Landi, M., Amato, S., Garofalo, M., D'Avino, M., Sensale, P., Maiolica, O., Santoro, R., Caso, P., Miceli, D., Maurea, N., Bianchi, U., Crispo, C., Chiariello, M., Perrone Filardi, P., Russo, L., Capuano, N., Ungaro, G., Vergara, G., Scafuro, F., D'Angelo, G., Campaniello, C., Bottiglieri, P., Volpe, A., Battista, R., De Risi, L., Cardillo, G., Sibilio, G., Marino, A. P., Silvestri, F., Predotti, P., Iervoglini, A., De Matteis, C., Sarnicola, P., Matarazzo, M. M., Baldi, S., Iuliano, V., Astarita, C., Cuccaro, P., Liguori, A., Liguori, G., Gregorio, G., Petraglia, L., Antonelli, G., Amodio, G., De Luca, I., Traversa, D., Franchini, G., Lenti, M. L., Cavallari, D., D'Agostino, C., Scalera, G., Altamura, C. M., Russo, M., Mascolo, A. R., Pettinati, G., Ciricugno, S. A., Scrutinio, D., Passantino, A., Mastrangelo, D., Di Masi, A., De Carne, R., Cannone, M., Dibiase, F., Pensato, M., Loliva, F., Trapani, F., Panettieri, I., Leone, L., Di Biase, M., Carrone, M., Gallone, V., Cocco, F., Costantini, M., Tritto, C., Cavalieri, F., Stella, L., Magliari, F., Callerame, M., De Giorgi, A., Pellegrino, L., Correra, M., Portulano, V., Nisi, G. L., Grassi, G., Cristallo, E., De Laura, D., Salerno, C., Fanelli, R., Villella, M., Pede, S., Renna, A., De Lorenzi, E., Urso, L., Lenti, V., Peluso, A., Baldi, N., Polimeni, G., Palma, P., Lauletta, R., Tagliamonte, E., Cirillo, T., Silvestri, B., Centonze, G., D'Alessandro, B., Truncellito, L., Mecca, D., Petruzzi, M. A., Coviello, R. O. M., Lopizzo, A., Chiaffitelli, M., Barbuzzi, S., Gubelli, S., Germinario, G., Cosentino, N., Mingrone, A., Vico, R., Borrello, G., Mazza, M. L., Cimino, R., Galasso, D., Cassadonte, F., Talarico, U., Perticone, F., Cassano, S., Catapano, F., Calemme, S., Feraco, E., Cloro, C., Misuraca, G., Caporale, R., Vigna, L., Spagnuolo, V., De Rosa, F., Spadafora, G., Zampaglione, G., Russo, R., Schipani, F. A., Ferragina, A. F., Stranieri, D., Musca, G., Carpino, C., Bencardino, P., Raimondo, F., Musacchio, D., Pulitanò, G., Ruggeri, A., Provenzano, A., Salituri, S., Musolino, M., Calandruccio, S., Marrari, A., Tripodi, E., Scali, R., Anastasio, L., Arone, A., Aragona, P., Donnangelo, L., Comito, M. G. A., Bilotta, F., Vaccaro, I., Rametta, R., Ventura, V., Bonvegna, A., Alì, A., Cinnirella, C., Raineri, M., Pompeo, F., Cascio Ingurgio, N., Carini, V., Coco, R., Giunta, G., Leonardi, G., Randazzo, V., Di Blasi, V., Tamburino, C., Russo, G., Mangiameli, S., Cardillo, R., Castelli, D., Inserra, V., Arena, A., Gulizia, M. M., Raciti, S., Rapisarda, G., Romano, R., Prestifilippo, P., Braschi, G. B., Ledda, G., Terrazzino, R., De Caro, M., Scilabra, G., Graffagnino, B., Grassi, R., Di Tano, G., Scimone, G. F., Vasquez, L., Coppolino, C., Casale, A., Castelli, M., D'Urso, G., D'Antonio, E., Lo Presti, L., Badalamenti, E., Conti, P., Sanfilippo, N., Cirrincione, V., Cinà, M. T., Cusimano, G., Taormina, A., Giuliano, P., Bajardi, A., Mandalà, V., Canonico, A., Geraci, G., Sabella, F. P., Enia, F., Floresta, A. M., Lo Cascio, I., Gumina, D., Cavallaro, A., Piccione, G., Ferrante, R., Blandino, M., Iudicello, M. S., Mossuti, E., Romano, G., Lombardo, L., Monastra, P., Di Vincenzo, D., Porcu, M., Orrù, P., Muscas, F., Giardina, G., Corda, M., Locci, G., Podda, A., Ledda, M., Siddi, P., Lai, C., Pili, G., Mercuro, G., Mureddu, G., Ganau, A., Meloni, G., Poddighe, G., Sanna, G., Barlera, Simona, Franzosi, Maria Grazia, Porcu, Maurizio, Yusuf, Salim, Camerini, Fulvio, Cohn, Jay N., Decarli, Adriano, Pitt, Bertram, Sleight, Peter, Poole-Wilson, Philip A., Geraci, Enrico, Scherillo, Marino, Fabbri, Gianna, Bartolomei, Barbara, Bertoli, Daniele, Cobelli, Franco, Fresco, Claudio, Ledda, Antonietta, Levantesi, Giacomo, Opasich, Cristina, Rusconi, Franco, Sinagra, Gianfranco, Turazza, Fabio, Volpi, Alberto, Ceseri, Martina, Alongi, Gianluca, Atzori, Antonio, Bambi, Filippo, Bastarolo, Desiree, Bianchini, Francesca, Cangioli, Iacopo, Canu, Vittoriana, Caporusso, Concetta, Cenni, Gabriele, Cintelli, Laura, Cocchio, Michele, Confente, Alessia, Fenicia, Eva, Friso, Giorgio, Gianfriddo, Marco, Grilli, Gianluca, Lazzaro, Beatrice, Lonardo, Giuseppe, Luise, Alessia, Nota, Rachele, Orlando, Mariaelena, Petrolo, Rosaria, Pierattini, Chiara, Pierota, Valeria, Provenzani, Alessandro, Quartuccio, Velia, Ragno, Anna, Serio, Chiara, Spolaor, Alvise, Tafi, Arianna, Tellaroli, Elisa, Ghio, Stefano, Ghizzardi, Elisa, Masson, Serge, Crociati, Lella, La Rovere, Maria Teresa, Corrà, Ugo, Di Giulio, Paola, Finzi, Andrea, Gorini, Marco, Milani, Valentina, Orsini, Giampietro, Bianchini, Elisa, Cabiddu, Silvia, Cangioli, Ilaria, Cipressa, Laura, Cipressa, Maria Lucia, Di Bitetto, Giuseppina, Ferri, Barbara, Galbiati, Luisa, Lorimer, Andrea, Pera, Carla, Priami, Paola, and Vasamì, Antonella

Subjects
Blood Glucose, Male, Glycated Hemoglobin A, heart failure, Kaplan-Meier Estimate, prediabetes, 030204 cardiovascular system & hematology, time factors, Settore MED/11, cause of death, 0302 clinical medicine, Glycemic control, prediabetic state, Cause of Death, italy, middle aged, Prevalence, 80 and over, double-blind method, blood glucose, risk factors, 030212 general & internal medicine, Prediabetes, Rosuvastatin Calcium, humans, rosuvastatin calcium, Cause of death, Original Research, Metabolic Syndrome, Aged, 80 and over, adult, Chronic heart failure, Diabetes mellitus, Heart failure, Mortality, Cardiology and Cardiovascular Medicine, Hazard ratio, chronic heart failure, diabetes mellitus, glycemic control, mortality, Treatment Outcome, Adolescent, Biomarkers, Chronic Disease, Diabetes Mellitus, Fatty Acids, Omega-3, Double-Blind Method, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hospitalization, Heart Failure, Italy, Prediabetic State, Risk Assessment, Proportional Hazards Models, Risk Factors, Time Factors, risk assessment, Middle Aged, kaplan-meier estimate, aged, female, Prediabete, young adult, Female, omega-3, Human, hospitalization, Adult, medicine.medical_specialty, Diabetes mellitu, proportional hazards models, Time Factor, hydroxymethylglutaryl-coa reductase inhibitors, prevalence, fatty acids, 03 medical and health sciences, Young Adult, male, Internal medicine, Post-hoc analysis, glycated hemoglobin a, medicine, Intensive care medicine, Aged, Glycated Hemoglobin, Proportional hazards model, business.industry, Risk Factor, biomarkers, Biomarker, medicine.disease, Clinical trial, adolescent, Proportional Hazards Model, treatment outcome, aged, 80 and over, chronic disease, fatty acids, omega-3, cardiology and cardiovascular medicine, Hydroxymethylglutaryl-CoA Reductase Inhibitor, business
Abstract

Background The independent prognostic impact of diabetes mellitus ( DM ) and prediabetes mellitus (pre‐ DM ) on survival outcomes in patients with chronic heart failure has been investigated in observational registries and randomized, clinical trials, but the results have been often inconclusive or conflicting. We examined the independent prognostic impact of DM and pre‐ DM on survival outcomes in the GISSI ‐HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca‐Heart Failure) trial. Methods and Results We assessed the risk of all‐cause death and the composite of all‐cause death or cardiovascular hospitalization over a median follow‐up period of 3.9 years among the 6935 chronic heart failure participants of the GISSI ‐ HF trial, who were stratified by presence of DM (n=2852), pre‐ DM (n=2013), and non‐ DM (n=2070) at baseline. Compared with non‐ DM patients, those with DM had remarkably higher incidence rates of all‐cause death (34.5% versus 24.6%) and the composite end point (63.6% versus 54.7%). Conversely, both event rates were similar between non‐ DM patients and those with pre‐ DM . Cox regression analysis showed that DM , but not pre‐ DM , was associated with an increased risk of all‐cause death (adjusted hazard ratio, 1.43; 95% CI , 1.28–1.60) and of the composite end point (adjusted hazard ratio, 1.23; 95% CI , 1.13–1.32), independently of established risk factors. In the DM subgroup, higher hemoglobin A1c was also independently associated with increased risk of both study outcomes (all‐cause death: adjusted hazard ratio, 1.21; 95% CI , 1.02–1.43; and composite end point: adjusted hazard ratio, 1.14; 95% CI , 1.01–1.29, respectively). Conclusions Presence of DM was independently associated with poor long‐term survival outcomes in patients with chronic heart failure. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 00336336.

Published
2017
Full Text
View/download PDF

30. Mortality in Multicenter Critical Care Trials: An Analysis of Interventions With a Significant Effect

Author

Laura Ruggeri, Rosalba Lembo, Paolo A. Del Sarto, Tiziana Bove, Marco Comis, Giuseppe Buscaglia, Giuseppe Ponticelli, Luca Cabrini, Simona Silvetti, Fabrizio Monaco, Fabio Caramelli, Mario Musu, Speranza Bocchino, Marina Pieri, Andrea Székely, Alessandro Forti, Marco Ganzaroli, Stefania Pisarra, Rosetta Lobreglio, Alberto Zangrillo, Paolo Feltracco, Giovanni Borghi, Rinaldo Bellomo, Maria Chiara Zucchetti, Massimiliano Greco, Gabriele Alvaro, P. C. Bergonzi, Laura Pasin, Antonio Pisano, Giovanni Pala, Agostino Roasio, Sergio Colombo, Laura Corno, Gianluca Paternoster, Lino Callegher, Manuela Angelone, Massimo Zambon, Massimiliano Conte, Fabio Guarracino, Roberta Meroni, Gabriele Finco, Francesco Santini, Giovanni Landoni, Marta Mucchetti, Landoni, Giovanni, Comis, M, Conte, M, Finco, G, Mucchetti, M, Paternoster, G, Pisano, A, Ruggeri, L, Alvaro, G, Angelone, M, Bergonzi, Pc, Bocchino, S, Borghi, G, Bove, T, Buscaglia, G, Cabrini, L, Callegher, L, Caramelli, F, Colombo, S, Corno, L, Del Sarto, P, Feltracco, P, Forti, A, Ganzaroli, M, Greco, M, Guarracino, F, Lembo, R, Lobreglio, R, Meroni, R, Monaco, F, Musu, M, Pala, G, Pasin, L, Pieri, M, Pisarra, S, Ponticelli, G, Roasio, A, Santini, F, Silvetti, S, Székely, A, Zambon, M, Zucchetti, Mc, Zangrillo, Alberto, and Bellomo, R.

Subjects
consensus conference, critically ill patients, intensive care unit, multicenter randomized controlled trials, noninvasive ventilation, nonsurgical interventions, treatments to increase and decrease mortality, Research design, Male, medicine.medical_specialty, Critical Care, MEDLINE, Psychological intervention, Consensus conference, Critically ill patients, Intensive care unit, Multicenter randomized controlled trials, Noninvasive ventilation, Nonsurgical interventions, Treatments to increase and decrease mortality, Female, Fibrosis, Humans, Hypnotics and Sedatives, Hypothermia, Induced, Multicenter Studies as Topic, Prone Position, Randomized Controlled Trials as Topic, Reproducibility of Results, Research Design, Respiration, Artificial, Tranexamic Acid, Critical Care and Intensive Care Medicine, Hypothermia, law.invention, Randomized controlled trial, law, Critical care nursing, Intensive care, Medicine, Intensive care medicine, business.industry, Respiration, Induced, Clinical trial, Artificial, business
Abstract

OBJECTIVES: We aimed to identify all treatments that affect mortality in adult critically ill patients in multicenter randomized controlled trials. We also evaluated the methodological aspects of these studies, and we surveyed clinicians' opinion and usual practice for the selected interventions.DATA SOURCES: MEDLINE/PubMed, Scopus, and Embase were searched. Further articles were suggested for inclusion from experts and cross-check of references.STUDY SELECTION: We selected the articles that fulfilled the following criteria: publication in a peer-reviewed journal; multicenter randomized controlled trial design; dealing with nonsurgical interventions in adult critically ill patients; and statistically significant effect in unadjusted landmark mortality. A consensus conference assessed all interventions and excluded those with lack of reproducibility, lack of generalizability, high probability of type I error, major baseline imbalances between intervention and control groups, major design flaws, contradiction by subsequent larger higher quality trials, modified intention to treat analysis, effect found only after adjustments, and lack of biological plausibility.DATA EXTRACTION: For all selected studies, we recorded the intervention and its comparator, the setting, the sample size, whether enrollment was completed or interrupted, the presence of blinding, the effect size, and the duration of follow-up.DATA SYNTHESIS: We found 15 interventions that affected mortality in 24 multicenter randomized controlled trials. Median sample size was small (199 patients) as was median centers number (10). Blinded trials enrolled significantly more patients and involved more centers. Multicenter randomized controlled trials showing harm also involved significantly more centers and more patients (p = 0.016 and p = 0.04, respectively). Five hundred fifty-five clinicians from 61 countries showed variable agreement on perceived validity of such interventions.CONCLUSIONS: We identified 15 treatments that decreased/increased mortality in critically ill patients in 24 multicenter randomized controlled trials. However, design affected trial size and larger trials were more likely to show harm. Finally, clinicians view of such trials and their translation into practice varied.

Published
2015

Catalog

Books, media, physical & digital resources
See catalog results