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3. The Chronic Angioedema Registry (CARE): Rationale, Methods and Implementation.

Author

Buttgereit, T., Aulenbacher, F., Gutsche, A., Kolkhir, P., Weller, K., Vera Ayala, C., Magerl, M., Farkas, H., Grumach, A. S., Aygören‐Pürsün, E., Bara, N., Ben‐Shoshan, M., Bernstein, J., Betschel, S., Bouillet, L., Caballero, T., Cancian, M., Castaldo, A. J., Cimbollek, S., and Cohn, D. M.

Subjects
SCIENTIFIC knowledge, RESEARCH personnel, MEDICAL research personnel, ADVISORY boards, RESEARCH grants
Abstract

The Chronic Angioedema Registry (CARE) is an international disease registry that aims to improve patient care for recurrent angioedema. It collects data through questionnaires completed by physicians and patients to assess disease control, quality of life, and treatment responses. However, the outcomes may not apply to less severe cases typically seen in primary care or community settings, and the findings may not be generalizable to patients from diverse ethnic backgrounds. The document also lists conflicts of interest for authors involved in the CARE study, who have disclosed financial relationships with pharmaceutical companies and other organizations. The study received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin. [Extracted from the article]

Published
2024
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5. Fixed-Dose Subcutaneous C1-Inhibitor Liquid for Prophylactic Treatment of C1-INH-HAE: SAHARA Randomized Study

Author

Keith, P., Yang, W., Maurer, M., Martinez-Saguer, I., Farkas, H., Reshef, A., Kivity, S., Moldovan, D., Caballero, T., Guilarte, M., Hernandez, M.D., González-Quevedo, M.T., Banerji, A., Bernstein, J., Bewtra, A., Craig, T., Fineman, S., Gower, R., Jacobs, J., Johnston, D., Kashkin, J., Li, H.H., Lumry, W.R., Manning, M., McNeil, D., Melamed, I., Mumneh, N., Nickel, T., Panuto, J., Soteres, D., Tachdjian, R., Offenberger, J., Wedner, J., Lumry, William R., Martinez-Saguer, Inmaculada, Yang, William H., Bernstein, Jonathan A., Jacobs, Joshua, Moldovan, Dumitru, Riedl, Marc A., Johnston, Douglas T., Li, H. Henry, Tang, Yongqiang, Schranz, Jennifer, Lu, Peng, Vardi, Moshe, and Farkas, Henriette

Published
2019
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7. Gastric GDF15 levels are regulated by age, sex, and nutritional status in rodents and humans

Author

Pena-Leon, V., primary, Perez-Lois, R., additional, Villalon, M., additional, Folgueira, C., additional, Barja-Fernández, S., additional, Prida, E., additional, Baltar, J., additional, Santos, F., additional, Fernø, J., additional, García-Caballero, T., additional, Nogueiras, R., additional, Quiñones, M., additional, Al-Massadi, O., additional, and Seoane, L. M., additional

Published
2023
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8. Data-driven flow cytometry classification of blast differentiation in older patients with acute myeloid leukemia

Author

Rojas, F., Longoni, H., Milone, G., Fernández, I., Conciencia, Clínica, Ramirez, R., Canepa, C., Saba, S., Balladares, G., Ventiurini, C., Mariano, R., Negri, P., Prates, M.V., Milone, J., Fazio, P., Gelemur, M., Ciarlo, S., Bezares, F., López, L., García, J. J, Giunta, M., Kruss, M., Lafalse, D., Marquesoni, E., Casale, M.F., Gimenez, A., Brulc, E.B., Perusini, M.A., Palmer, L., Correa, M.E., Jaramillo, F.J., Rosales, J., Sossa, C., Herrera, J.C., Arango, M., Holojda, J., Golos, A., Ejduk, A., Ochrem, B., Małgorzata, G., Waszczuk-Gajda, A., Drozd-Sokolowska, J., Czemerska, M., Paluszewska, M., Zarzycka, E., Masternak, A., Hawrylecka, Dr., Podhoreka, M., Giannopoulos, K., Gromek, T., Oleksiuk, J., Armatys, bA., Helbig, G., Sobas, M., Szczepaniak, A., Rzenno, E., Rodzaj, M., Piatkowska-Jakubas, B., Skret, A., Pluta, A., Barańska, E., Vasconcelos, G., Brioso, J., Nunes, A., Bogalho, I., Espadana, A., Coucelo, M., Marini, S., Azevedo, J., Crisostomo, A.I., Ribeiro, L., Pereira, V., Botelho, A., Mariz, J.M., Guimaraes, J.E., Aguiar, E., Coutinho, J., Noriega, V., García, L., Varela, C., Debén, G., González, M.R., Encinas, M., Bendaña, A., González, S., Bello, J.L., Albors, M., Algarra, L., Romero, J.R., Bermon, J.S., Varo, M.J., López, V., López, E., Mora, C., Amorós, C., Romero, A., Jaramillo, A., Valdez, N., Molina, I., Fernández, A., Sánchez, B., García, A., Castaño, V., López, T., Bernabeu, J., Sánchez, M.J., Fernández, C., Gil, C., Botella, C., Fernández, P., Pacheco, M., Tarín, F., Verdú, J.J., García, M.J., Mellado, A., García, M.C., González, J., Castillo, T., Colado, E., Alonso, S., Recio, I., Cabezudo, M., Davila, J., Rodríguez, M.J., Barez, A., Díaz, B., Prieto, J., Arnan, M., Marín, C., Mansilla, M., Balaberdi, A., Amutio, M.E., del Orbe, R.A., Ancin, I., Ruíz, J.C., Olivalres, M., Gómez, C., gonzález, I., Celis, M., Atutxa, K., Carrascosa, T., Artola, T., Lizuain, M., Rodriguez, J .I., Arce, O., Márquez, J.A., Atuch, J., Marco de Lucas, F., Díez, Z., Dávila, B., Cantalejo, R., Díaz, M., Labrador, J., Serra, F., Hermida, G., Díaz, F.J., de Vicente, P., Álvarez, R., Alonso, C., Bergua, J.M., Ugalde, N., Pardal, E., Saldaña, R., Rodríguez, F., Martín, E., Hermosín, L., Garrastazul, M.P., Marchante, I., Raposo, J.A., Capote, F.J., Colorado, M., Batlle, A., Yañez, L., García, S., González, P., Ocio, E.M., Briz, M., Bermúdez, A., Jiménez, C., Beltrán, S., Montagud, M., Castillo, I., García, R., Gascón, A., Clavel, J., Lancharro, A., Lnares, L., Herráez, M.M., Milena, A., Romero, M.J., Hernández, B., Calle, C., Benegas, R., Bolívar, Dr., Serrano, J., Dorado, F.J., Sánchez, J., Martínez, M.C., Cerveró, C.J., Busto, M.J., Bernal, M., Moratalla, L., Mesa, Z., Jurado, M., De Miguel, D., Santos, A.B., Arbeteta, J., Pérez, E., Caminos, N., Uresandi, N., Argoitiaituart, N., Swen, J., Uranga, A., Olazaba, I., Gainza, E., Romero, P., Gil, E., Palma, A.J., Gómez, K.G., Solé, M., Rodríguez, J.N., Murillo, I.M., Marco, J., Serena, J., Marco, V., Perella, M., Costilla, L., López, J.A., Baena, A., Almagro, P., Hermosilla, M., Esteban, A., Campeny, B.A., Nájera, M.J., Herrra, P., Fernández, R., González, J.D., Torres, L., Jiménez, S., Gómez, M.T., Bilbao, C., Rodríguez, C., Hong, A., Ramos de Laón, Y., Afonso, V., Ramos, F., Fuertes, M., de Cabo, E., Aguilera, C., Megido, M., García, T., Lavilla, E., Varela, M., Ferrero, S., Arias, J., Vizcaya, L., Roldán, A., Vilches, A., Penalva, M.J., Vázquez, J., Calderón, M.T., Matilla, A., Serí, C., Otero, M.J., García, N., Sandoval, E., Franco, C., Flores, R., Bravo, P., López, A., López, J.L., Blas, C., Díez, A., Alonso, J.M., Soto, C., Arenas, A., García, J., Martín, Y., Villafuerte, P.S., Magro, E., Bautista, G., De Laiglesia, A., Rodríguez, G., Solán, L., Chicano, M., Balsalobre, P., Monsalvo, S., Font, P., Carbonell, D., Martínez, C., Humala, K., Kerguelen, A.E., Hernández, D., Gasior, M., Gómez, P., Sánchez, I., Redondo, S., Llorente, L., Bengochea, M., Pérez, J., Sebrango, A., M. santero, Morales, A., Figuera, A., Villafuerte, P., Alegre, A., Fernández, E., Alonso, A., Martínez, M.P., Martínez, J., Cedena, M.T., Moreno, L., De la Fuente, A., García, D., Chamorro, C., Pradillo, V., Martí, E., Sánchez, J.M., Delgado, I., Rosado, B., Velasco, A., Miranda, C., Salvatierra, G., Foncillas, M., Hernández, J.A., Escolano, C., Benabente, C., Martínez, R., Polo, M., Anguita, E., Riaza, R., Amores, G., Requena, M.J., Javier, F., Villaloón, L., Aláez, C., Nistal, S., Navas, B., Andreu, M.A., Herrera, P., López, J., García, M., Moreno, M.J., Queipo, M.P., Hernández, A., Barrios, M., Heiniger, A., Jiménez, A., Contento, A., López, F., Alcalá, M., Lorente, S., González, M., Morales, E.M., Gutierrez, J., Serna, M.J., Beltrán, V., Romera, M., Berenguer, M., MArtínez, A., Tejedor, A., Amigo, M.L., Ortuño, F., Jerez, A., López, O., Moraleda, J.M., Rosique, P., Gómez, J., Garay, M.C., Cerezuela, P., MArtínez, A.B., González, A., Ibáñez, J., Alfaro, M.J., Mateos, M., Goñi, M.A., Araiz, M.A., Gorosquieta, A., Zudaire, M., Viguria, M., Zabala, A., Alvarellos, M., Quispe, I., Sánchez, M.P., Hurtado, G., Pérez, M., Burguete, Y., Areizaga, N., Galicia, T., Rifón, J., Alfonso, A., Prósper, F., Marcos, M., Tamariz, L.E., Riego, V., Manubens, A., Larrayoz, M.J., Calasanz, M.J., Mañú, A., Paiva, B., Vázquez, I., Burgos, L., Pereiro, M., Rodríguez, M., Pastoriza, M.C., Mendez, J.A., Sastre, J.L., Iglesias, M., Ulibarrena, C., Campoy, F., Jaimes, D., Albarrán, B., Solano, J., Silvestre, A., Albo, C., Suarez, S., Loureiro, C., Figueroa, I., Fernández, M.A., Martínez, A., Poderós, C., Vazquez, J., Iglesias, L., Nieto, A., Torrado, T., Martínez, A.M., Amador, M.L., Oubiña, P., Feijó, E., Dios, A., Loyola, I., Roreno, R., Simiele, A., Álvarez, L., Turcu, V., Vidriales, B., Avendaño, A., Chillón, C., González, V., Govantes, J.V., Rubio, S., Tapia, M., Olivier, C., Queizán, J.A., Pérez, O., Vera, J.A., Muñoz, C., rodriguez, A., González, N., Pérez, J.A., Soria, E., I.Espigado, Falantes, J., Montero, I., García, P., Rodríguez, E., Carrillo, E., Caballero, T., García, C., Couto, C., Simón, I., Gómez, M., Aguilar, C., González, B.J., Lakhwani, S., Bienert, A., González, B., Cabello, A., Oliva, A.Y., González, H., Sancho, L., Paricio, M., Perdiguer, L., Solano, F., Lerma, A., Martínez, M.D., Gómez, M.I., Yeguas, A., Montesinos, P., Barragán, E., Sargas, C., Amigo, R., Martinez, D., Boluda, B., Rodríguez, R., Acuña, E., Cano, I., Escrivá, A., Pedreño, M., Navalón, A., Orts, M., Sayas, M.J., Fernández, M.J., Juan, M.L., Gómez, E., Gimeno, M., Donato, E., Cejalvo, M., Tormo, M., Calabuig, M., Navarro, B., Martin, I., Villamont, E., Miralles, A., Lluch, R., Moragues, M., Ruiz, M.A., Benet, C., Valero, M., Linares, M., Collado, R., Orero, M., Ibañez, P., Lis, M.J., Pérez, P.L., Roig, M., López, M., Mena, A.V., Picón, I., Cánovas, V., Palacios, A., Cuello, R., Borrego, J., burgois, M., Cantalapiedra, A., Norberto, O., Angomas, E., Cidoncha, B., Cuevas, L., Robles, D., Mendiazabal, A., Oiartzabal, I., Guinea de Castro, J.M., Montes, C., Carrasco, V., Pérez, A., Moneva, J.J., Olave, M., Bonafonte, E., Mayor, L., Azaceta, G., Palomera, L., Malo, M., Escobar, M.J., Grasa, J.M., De Rueda, B., Aulés, A., Salvador, C., Ansó, V., Iborra, A., Delagado, P., Rubio, A., Stevenazzi, M., Alpire, I., Irigoin, V., Díaz, L., Guillermo, C., Guadagna, R., Grille, S., Oliver, C., Boada, M., Vales, V., Prado, A.I., De los Santos, A.P., Simoes, Catia, Gonzalez, Carmen, Vergez, François, Sarry, Audrey, Bertoli, Sarah, Ariceta, Beñat, Martínez-Cuadrón, David, Bergua, Juan-Miguel, Vives, Susana, Algarra, Lorenzo, Tormo, Mar, Martinez, Pilar, Serrano, Josefina, Herrera, Pilar, Ramos, Fernando, Salamero, Olga, Lavilla, Esperanza, Gil, Cristina, Lopez-Lorenzo, Jose-Luis, Vidriales, Maria-Belen, Chillon, Carmen, Labrador, Jorge, Falantes, Jose-Francisco, Sayas, María-José, Ayala, Rosa, Martinez-Lopez, Joaquin, Villar, Sara, Calasanz, Maria-Jose, Prosper, Felipe, San-Miguel, Jesús F., Sanz, Miguel Á., Récher, Christian, Paiva, Bruno, and Montesinos, Pau

Published
2024
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9. Primary systemic therapy in HER2-positive operable breast cancer using trastuzumab and chemotherapy: efficacy data, cardiotoxicity and long-term follow-up in 142 patients diagnosed from 2005 to 2016 at a single institution

Author

Antolín S, Acea B, Albaina L, Concha Á, Santiago P, García-Caballero T, Mosquera JJ, Varela JR, Soler R, and Calvo L

Subjects
Neoadjuvant therapy, HER2-positive breast cancer, pathologic complete response, cardiotoxicity, survival, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Silvia Antolín,1 Benigno Acea,2 Luis Albaina,2 Ángel Concha,3 Paz Santiago,3 Tomás García-Caballero,4 Joaquín J Mosquera,5 José Ramón Varela,5 Rafaela Soler,5 Lourdes Calvo1 1Medical Oncology Department, Breast Unit, A Coruña University Hospital, A Coruña, Spain; 2Surgery Department, Breast Unit, A Coruña University Hospital, A Coruña, Spain; 3Anatomic Pathology Department, Breast Unit, A Coruña University Hospital, A Coruña, Spain; 4Department of Morphological Sciences, University of Santiago de Compostela, Santiago de Compostela, A Coruña, Spain; 5Radiology Department, Breast Unit, A Coruña University Hospital, A Coruña, Spain Objective: The aim of this study was to evaluate the efficacy, cardiotoxicity profile and long-term benefits of neoadjuvant therapy in human epidermal growth factor receptor 2-positive operable breast cancer patients. Patients and methods: A total of 142 patients diagnosed from 2005 to 2016 were included in the study. The treatment consisted of a sequential regimen of taxanes and anthracyclines plus trastuzumab. The clinical and pathological responses were evaluated and correlated with clinical and biological factors. The cardiotoxicity profile and long-term benefits were analyzed. Results: The median age was 49 years, and 4%, 69% and 27% of patients had stage I, II and III breast cancer, respectively, while 10% had inflammatory breast cancer at diagnosis. Hormone receptor (HR) status was negative in 43%, and 62% had grade III breast cancer. The clinical complete response rate was 49% and 63% as assessed using ultrasound and magnetic resonance imaging, respectively, and this allowed a high rate of conservative surgery (66%). The pathological complete response (pCR) rate was 52%, and it was higher in HR-negative (64%) patients than in HR-positive (41%) patients and in grade III breast cancer (53%) patients than in grade I–II breast cancer (45%) patients. Patients who achieved pCR had longer disease-free survival and a trend toward improved overall survival. A total of 2% of patients showed a 10% decrease in left ventricular ejection fraction to

Published
2018

10. Immunohistochemical assay for neuron-specific enolase, synaptophysin, and RB-associated protein as a diagnostic aid in advanced retinoblastomas

Author

López López JC, Fernández Alonso N, Cuevas Álvarez J, García-Caballero T, and Pastor Jimeno JC

Subjects
Retinoblastoma, immunohistochemistry, neuron-specific enolase, synaptophysin, pRb, Ophthalmology, RE1-994
Abstract

José Carlos López López,1 Nieves Fernández Alonso,1 Juan Cuevas Álvarez,1,2 Tomás García-Caballero,2 José Carlos Pastor Jimeno3 1Ocular Pathology Laboratory, Instituto Universitario de Oftalmobiología Aplicada (IOBA), University of Valladolid, Valladolid, Spain; 2Department of Pathology, Hospital Clínico Universitario, Santiago de Compostela, Spain; 3Retina Group, Instituto Universitario de Oftalmobiología Aplicada (IOBA), University of Valladolid, Hospital Clínico Universitario, Valladolid, Spain Purpose: We evaluated the expression of the neural markers, neuron-specific enolase, and synaptophysin, as a tool to confirm the diagnosis of retinoblastoma (RB) in undifferentiated and advanced tumors. Additionally, we determined whether the extent of RB-associated protein (pRb) expression is helpful in assessing the prognosis in RB patients. Methods: Conventional whole tissue section and tissue microarray immunohistochemistry for neuron-specific enolase, synaptophysin, and pRb were carried out in a series of 22 RBs. Results: Neuron-specific enolase and synaptophysin were expressed in 75%–100% of the tumor cells, and the staining intensity was strong. Two RBs expressed pRb in 75%–100% of the tumor cells, also with strong staining intensity. Concordance between the immunohistochemical outcomes for whole tissue staining and tissue microarray staining was 76.2% for neuron-specific enolase, 85.7% for synaptophysin, and 80.0% for pRb. Conclusion: Neuron-specific enolase and synaptophysin have the potential to be useful markers for the diagnosis of RBs. Extensive and strong pRb staining is not associated with less aggressive tumor behavior according to the pathologic classification of RBs. Keywords: retinoblastoma, immunohistochemistry, neuron-specific enolase, synaptophysin, pRb

Published
2018

13. Misdiagnosis trends in patients with hereditary angioedema from the real-world clinical setting

Author

Aberer, W., Grumach, A., Bygum, A., Blanchard Delaunay, C., Bouillet, L., Coppere, B., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Sobel, A., Arnolds, J., Aygören-Pürsün, E., Baş, M., Bauer, A., Bork, K., Martinez, I., Maurer, M., Papadopoulou-Alataki, E., Psarros, F., Graif, Y., Kivity, S., Reshef, A., Toubi, E., Arcoleo, F., Cicardi, M., Manconi, P., Marone, G., Montinaro, V., Baeza, M.L., Caballero, T., Cabañas, R., Guilarte, M., Hernandez de Rojas, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Sáenz de San Pedro, B., Bjorkander, J., Helbert, M., Longhurst, H.J., Zanichelli, Andrea, Longhurst, Hilary J., Maurer, Marcus, Bouillet, Laurence, Aberer, Werner, Fabien, Vincent, Andresen, Irmgard, and Caballero, Teresa

Published
2016
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15. Estimation of EuroQol 5-Dimensions health status utility values in hereditary angioedema

Author

Aygören-Pürsün E, Bygum A, Beusterien K, Hautamaki E, Sisic Z, Boysen HB, and Caballero T

Subjects
Hereditary angioedema, health-related quality of life, burden of illness, EQ-5D, Medicine (General), R5-920
Abstract

Emel Aygören-Pürsün,1 Anette Bygum,2 Kathleen Beusterien,3 Emily Hautamaki,4 Zlatko Sisic,5 Henrik B Boysen,6 Teresa Caballero7 1Angioedema Centre, Department for Children and Adolescents, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; 2Hereditary Angioedema Centre Denmark, Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark; 3Outcomes Research Strategies in Health, Washington, DC, 4Patient Reported Outcomes, Oxford Outcomes Inc., an ICON plc company, Bethesda, MD, USA; 5ViroPharma Incorporated, Chatsworth House, Maidenhead, UK; 6HAEi – Hereditary Angioedema International Patient Organization for C1 Inhibitor Deficiencies, Skanderborg, Denmark; 7Allergy Department, Hospital La Paz Institute for Health Research (IdiPaz), Biomedical Research Network on Rare Diseases U754 (CIBERER), University Hospital La Paz, Madrid, Spain Objective: To estimate health status utility (preference) weights for hereditary angioedema (HAE) during an attack and between attacks using data from the Hereditary Angioedema Burden of Illness Study in Europe (HAE-BOIS-Europe) survey. Utility measures quantitatively describe the net impact of a condition on a patient’s life; a score of 0.0 reflects death and 1.0 reflects full health.Study design and methods: The HAE-BOIS-Europe was a cross-sectional survey conducted in Spain, Germany, and Denmark to assess the real-world experience of HAE from the patient perspective. Survey items that overlapped conceptually with the EuroQol 5-Dimensions (EQ-5D) domains (pain/discomfort, mobility, self-care, usual activities, and anxiety/depression) were manually crosswalked to the corresponding UK population-based EQ-5D utility weights. EQ-5D utilities were computed for each respondent in the HAE-BOIS-Europe survey for acute attacks and between attacks.Results: Overall, a total of 111 HAE-BOIS-Europe participants completed all selected survey items and thus allowed for computation of EQ-5D-based utilities. The mean utilities for an HAE attack and between attacks were 0.44 and 0.72, respectively. Utilities for an acute attack were dependent on the severity of pain of the last attack (0.61 for no pain or mild pain, 0.47 for moderate pain, and 0.08 for severe pain). There were no significant differences across countries. Mean utilities derived from the study approach compare sensibly with other disease states for both acute attacks and between attacks.Conclusion: The impacts of HAE translate into substantial health status disutilities associated with acute attacks as well as between attacks, documenting that the detrimental effects of HAE are meaningful from the patient perspective. Results were consistent across countries with regard to pain severity and in comparison to similar disease states. The results can be used to raise awareness of HAE as a serious disease with wide-ranging personal and social impacts. Keywords: hereditary angioedema, health-related quality of life, burden of illness, EQ-5D

Published
2016

16. A grammar of Ashéninka (Ucayali-Pajonal)

Author

Pedrós Caballero, T., Mous, M., Crevels, M., Ameka, F., Danielsen, S., Klamer, M., Michael, L., and Leiden University

Subjects
Languages of Peru, Atalaya, Campan, Arawakan, Reality status, Ashéninka, Agglutinative language, Glossed texts, South American language, Dialect continuum
Abstract

This thesis describes the Ashéninka language as it is spoken in the Gran Pajonal plateau and the upper Ucayali River in Peru, an area where the last Andean foothills give way to the Amazonian lowlands. The number of speakers is estimated at around 10,000. This language forms part of the so-called Ashé-Ashá dialect continuum, which is part of the group of Campan languages, a subgroup of the Arawak language family. The Ashéninka people live in so-called 'comunidades nativas', indigenous settlements with official authorities that are legally recognised in Peru.The thesis presents a description of the phonology, morphology and syntax of the language. The discussion of the morphology is by far the longest, with the description of verbs comprising roughly half of the thesis due to the complex verbal morphology. Furthermore, the text discusses the relations within the Ashé-Ashá dialect continuum, compares the reality status systems of the different Campan languages and shows the partial loss of this system in Ucayali-Pajonal Ashéninka. Other relevant findings include the probable origin of the word 'campa', the non contrastive but distinctive affricates, the long adjectives denoting forms, the discussion of the subject cross-referenced with a suffix instead of the usual prefix, the proposal of the existence of a future suffix in all Ashé-Ashá varieties, and some suffixes that have not been mentioned in the literature on other Ashé-Ashá varieties.Moreover, the thesis contains annexes with 11 glossed texts from different genres and a vocabulary of 625 words.

Published
2023

22. Management of hereditary angioedema in pregnant women: a review

Author

Caballero T, Canabal J, Rivero-Paparoni D, and Cabañas R

Subjects
Gynecology and obstetrics, RG1-991
Abstract

Teresa Caballero,1,2 Julio Canabal,1 Daniela Rivero-Paparoni,1 Rosario Cabañas1 1Hospital La Paz Institute for Health Research, (IdiPaz) 2Biomedical Research Network on Rare Diseases-U754 (CIBERER), Madrid, Spain Abstract: Three types of hereditary angioedema (HAE) have been described: two are due to C1 inhibitor (C1-INH) deficiency (C1-INH-HAE types I and II) and one is characterized by normal C1-INH (nC1-INH-HAE). The management of pregnancy in patients with HAE is often a clinical challenge owing to potential worsening of the disease in relation to the physiological increase in estrogens and the limited treatment options. This review addresses the potential influence of pregnancy on the clinical severity of hereditary angioedema and the management of this disease during pregnancy with currently available treatments. Keywords: hereditary angioedema, pregnancy, female, treatment, C1 inhibitor concentrate, tranexamic acid

Published
2014

25. 281P Prevalence of HER2-low breast cancer in the GEICAM/2011-06 trial: Agreement in HER2-low classification between standardized immunohistochemistry assays

Author

Rojo, F., Calvo-Martinez, L., B. bermejo, Bernet, L., Burgués, O., García-Caballero, T., Lopez-Tarruella Cobo, S., Pérez, S., Antolín-Novoa, S., Cejalvo, J.M., Gilarranz, Y. Jerez, Estevez, C. Morales, Rendo, C. Reboredo, Martinez, M.T.M., Herranz, J., Sánchez, R. Rincón, Caballero, R., Barnadas, A., De la Haba Rodriguez, J., and Jimenez, M. Martin

Published
2024
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27. Some points key to think the challenges of the social sciences today. A look from the communication and the critical possibility of the human being

Author

Luis Ricardo Navarro Díaz, Ricardo Sandoval B., and Tomás Caballero T

Subjects
History of scholarship and learning. The humanities, AZ20-999, Science (General), Q1-390, Social sciences (General), H1-99
Abstract

The following document presents the redefinition of the role of social sciences in several dimensions. First, the subject is approached from the perspective of history. In a second step, the paper discusses the challenges of social science education. Similarly, and in a third stage, it is proposed that the social sciences have for immediate task of understanding social reality as fragmented text. In connection with the foregoing, in the letter states that this type of science should be proposed as main objective .the study of man from the public sphere and relationship with the surroundings.

Published
2013

29. Safe administration of SARS-CoV-2 vaccine after desensitization to a biologic containing polysorbate 80 in a patient with polyethylene glycol-induced severe anaphylaxis and sensitization to polysorbate 80

Author

Nin-Valencia, A, primary, Fiandor, A, additional, Lluch, M, additional, Quirce, S, additional, Caballero, T, additional, Heredia Revuelto, R, additional, González-Muñoz, M, additional, Caballero, ML, additional, and Cabañas, R, additional

Published
2022
Full Text
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31. COMPLICACIONES TARDÍAS DE LA TERAPIA LÁSER COMO TRATAMIENTO DE LA TRANSFUSIÓN FETO-FETAL: CASO CLÍNICO

Author

Mauro Parra C, Josefina Bascuñán A, Camila Valencia M, Gustavo Rencoret P, Rafael Caballero T, and Susana Quezada L

Subjects
Gemelar, transfusión feto-fetal, secuencia anemia-policitemia, Twins, twin to twin transfusion syndrome, twin anemia-polycythemia sequence, Gynecology and obstetrics, RG1-991
Abstract

Presentamos la descripción del diagnóstico y manejo de una secuencia anemia-policitemia (SAP) que se presenta como complicación de una terapia láser exitosa en un embarazo gemelar monocorial cursando una transfusión feto-fetal (TFF) severa. Describimos la manifestación de esta complicación tardía de la terapia láser de la TFF severa y realizamos una revisión de la literatura internacional al respecto. A pesar del éxito de la introducción de la terapia láser en cuanto a la sobrevida y secuelas neonatales, recientemente se han descrito una serie de complicaciones de presentación tempranas o tardías. Entre las tardías, destacan la muerte de uno o ambos gemelos, recidiva de la TFF, y aparición de una SAP. Varios autores han descrito que la SAP sería secundaria a la presencia, o persistencia, de comunicaciones vasculares extremadamente pequeñas de flujo lento, las cuales llevan a una discordancia en los niveles de hemoglobina entre ambos gemelos, sin diferencias en sus volúmenes sanguíneos.We describe the diagnosis and management of twin anemia-polycythemia sequence (TAPS), which occurs as a late complication of successful laser therapy in twin monochorionic pregnancies developing severetwin to twin transfusion syndrome (TTTS). We offer a description of this late complication of laser therapy in this condition and a review of the related medical literature. Despite the successful introduction of laser therapy on the survival and neonatal sequelae, various early and late complications related to this procedure have been recently described. Among the late, stands out the death of one or both twins, recurrence of TTTS, and the appearance of TAPS. With regards TAPS, several authors have reported that it would be secondary to the presence, o persistence, of extremely small slow flow vascular communications, which lead to discre-pancies in the hemoglobin levéis between the twins, with no differences in blood volume.

Published
2011

34. The Icatibant Outcome Survey: 10 years of experience with icatibant for patients with hereditary angioedema

Author

Maurer, Marcus, Aberer, W., Caballero, T., Bouillet, L., Grumach, A.S., Botha, J., Andresen, I., Longhurst, H.J., and Publica

Subjects
icatibant, acute treatment, observational, registry, hereditary angioedema
Abstract

In patients with hereditary angioedema (HAE), bradykinin causes swelling episodes by activating bradykinin B2 receptors. Icatibant, a selective bradykinin B2 receptor antagonist, is approved for on-demand treatment of HAE attacks. The Icatibant Outcome Survey (IOS; NCT01034969) is an ongoing observational registry initiated in 2009 to monitor the effectiveness/safety of icatibant in routine clinical practice. As of March 2019, 549 patients with HAE type 1 or 2 from the IOS registry had been treated of 5995 total attacks. This article reviews data published from IOS over time which have demonstrated that the effectiveness of icatibant in a real-world setting is comparable to efficacy in clinical trials; one dose is effective for the majority of attacks; early treatment (facilitated by self-administration) leads to faster resolution and shorter attack duration; effectiveness/safety of icatibant has been shown across a broad range of patient subgroups, including children/adolescents and patients with HAE with normal C1 inhibitor levels; and tolerability has been demonstrated in patients aged ≥65 years. Additionally, this review highlights how IOS data have provided valuable insights into patients' diagnostic journeys and treatment behaviours across individual countries. Such findings have helped to inform clinical strategies and guidelines to optimise HAE management and limit disease burden.

Published
2022

35. The Treatment With the SGLT2 Inhibitor Empagliflozin Modifies the Hepatic Metabolome of Male Zucker Diabetic Fatty Rats Towards a Protective Profile

Author

Aragón-Herrera A, Otero-Santiago M, Anido-Varela L, Moraña-Fernández S, Campos-Toimil M, García-Caballero T, Barral L, Tarazón E, Roselló-Lletí E, Portolés M, Gualillo O, Moscoso I, Lage R, González-Juanatey JR, Feijóo-Bandín S, and Lago F

Subjects
diabetes, empagliflozin, inflammation, liver, metabolome
Abstract

The EMPA-REG OUTCOME (Empagliflozin, Cardiovascular Outcome Event Trial in patients with Type 2 Diabetes Mellitus (T2DM)) trial evidenced the potential of sodium-glucose cotransporter 2 (SGLT2) inhibitors for the treatment of patients with diabetes and cardiovascular disease. Recent evidences have shown the benefits of the SGLT2 inhibitor empagliflozin on improving liver steatosis and fibrosis in patients with T2DM. Metabolomic studies have been shown to be very useful to improve the understanding of liver pathophysiology during the development and progression of metabolic hepatic diseases, and because the effects of empagliflozin and of other SGLT2 inhibitors on the complete metabolic profile of the liver has never been analysed before, we decided to study the impact on the liver of male Zucker diabetic fatty (ZDF) rats of a treatment for 6 weeks with empagliflozin using an untargeted metabolomics approach, with the purpose to help to clarify the benefits of the use of empagliflozin at hepatic level. We found that empagliflozin is able to change the hepatic lipidome towards a protective profile, through an increase of monounsaturated and polyunsaturated glycerides, phosphatidylcholines, phosphatidylethanolamines, lysophosphatidylinositols and lysophosphatidylcholines. Empagliflozin also induces a decrease in the levels of the markers of inflammation IL-6, chemerin and chemerin receptor in the liver. Our results provide new evidences regarding the molecular pathways through which empagliflozin could exert hepatoprotector beneficial effects in T2DM.

Published
2022

36. PARTOGRAMA EN MUJERES MULTÍPARAS CON MANEJO MÉDICO DEL TRABAJO DE PARTO

Author

Mauro Parra C, Julio Astudillo D, Rafael Caballero T, Rodrigo Terra A, Max Araneda A, Arturo Atria A, Carlos Rau M, and Sebastián Pérez B

Subjects
Partograma, parto, multíparas, manejo del parto, Graphic analyses of labour, labour, multiparous, management of labour, Gynecology and obstetrics, RG1-991
Abstract

Antecedentes. La evaluación gráfica del parto fue descrito originalmente por Friedman, sin embargo, una descripción de la evolución del trabajo de parto con un manejo médico contemporáneo no ha sido completamente evaluado. Objetivo: Analizar el efecto de un manejo médico estandarizado del trabajo de parto, que incluye anestesia regional, rotura artificial de membranas y conducción ocitócica, sobre la fase activa del trabajo de parto en multíparas. Método. Análisis retrospectivo de 130 multíparas en trabajo de parto espontáneo, que ingresaron con 3 a 4 cm de dilatación. Resultados. Se observó una duración de la fase activa del trabajo de parto de aproximadamente 3,5 horas, con una progresión promedio de 1,5 cm/ h, produciéndose la mayor progresión entre los 7 y 9 cm de dilatación con 1,9 cm/h. La segunda fase del trabajo de parto presento una duración promedio de 28 minutos. Conclusiones. Nuestros resultados muestran que el manejo "médico estandarizado" del trabajo de parto no reduce los tiempos de la fase activa ni de la segunda fase en multíparas. Creemos que es necesario implementar estudios randomizados para determinar la influencia de este tipo manejo del trabajo de parto en la incidencia de cesáreasObjective. To analyze the influence of a standardised protocol for the management of labour applied during the active phase of labour. Method. The graphic partograms of 130 multiparous women with spontaneous onset of labor were retrospectively analysed. A standardised protocol was defined by use of regional anaesthesia, early rupture of membranes and oxytocin acceleration during the active phase of labour. Results. The mean duration of the active phase of labour and the mean cervical rate dilatation were approximately 3.5 hours and 1.5 cm/h, respectively. The maximum mean rate of dilatation was 1.9 cm/h at the range of 7 to 9 cm, being the mean duration of the second phase of labour only 28 minutes. Conclusions. This study shows that the application of this standardised protocol of management of labour do not appear to be associated with a shortenning in the duration of the active dilatation and second stage of labour. Therefore, it would be necessary to set up a randomized control trial to evaluate the influence of this kind of managements in the caesarean section rate

Published
2007

38. DIVULSIÓN DEL POLO INFERIOR: MÉTODO SEGURO Y EFICAZ PARA DISMINUIR LOS PARTOS ESPONTÁNEOS DESPUÉS DE LAS 41 SEMANAS

Author

Enrique Valdés R, Paula Candia P, Rodrigo Terra V, Jaime Escobar D, Rafael Caballero T, and Guido Juarez D

Subjects
Divulsión de polo, maduración cervical, embarazo en vías de prolongación, Membrane stripping, cervical maturation, prolonged pregnancy, Gynecology and obstetrics, RG1-991
Abstract

Objetivo: Conocer si la divulsión del polo inferior, realizada semanalmente desde las 38 semanas de gestación en pacientes de bajo riesgo, es un método seguro y eficaz para disminuir la incidencia de partos mayores de 41 semanas. Método: 110 embarazadas de bajo riesgo y de edad gestacional segura fueron randomizadas a divulsión de polo (casos) y no divulsión (controles). Desde las 38 semanas, tanto a las controles como las intervenidas, se les realizó tactos vaginales para evaluar pelvimetría, puntaje de Bishop y divulsión de polo en aquellas gestantes aleatorizadas y que cumplían las condiciones para poder realizar el procedimiento. El objetivo primario fue determinar la incidencia de parto espontáneo antes de las 41 semanas y el secundario fue evaluar la morbimortalidad materna y neonatal. Los datos fueron analizados por Chi cuadrado, test exacto de Fisher, test t de Student y test Wilcoxson rank-sum según correspondiera. Resultados: La población estudiada en ambos grupos fueron demográficamente similares. Las gestantes divulsionadas tuvieron significativamente (pObjective: To determine whether weekly sweeping or stripping membranes beginning at 38 weeks could safely reduce the spontaneous labor rate after 41 weeks. Methods: 110 antenatal low-risk patients with firm gestational dates were randomized to either a treatment or control group. Control subjects received gentle cervical examination each week to asses Bishop score, whereas the treatment group also underwent weekly stripping of membranes beginning at 38 weeks. The primary outcome was the spontaneous labor rate before 41 weeks. Secondary outcomes included maternal and neonatal morbidity. The data were analyzed using Chi square, Fisher exact test, Student t test and Wilcoxson rank-sum test. Results: The subjects were demographically similar between groups. Women who received treatment had fewer deliveries after 41 weeks than those in the control group (22,2% v/s 10,0%; p< 0,05). Maternal- neonatal complications were similar in both groups. Conclusion: The stripping of membranes is a safe and effective method to reduce the incidence of labors after 41 week

Published
2005

39. PREVALENCIA DE COLONIZACIÓN POR STREPTOCOCCUS AGALACTIAE (GRUPO B) DURANTE EL EMBARAZO PESQUISADO EN MEDIO DE CULTIVO SELECTIVO

Author

Enrique Valdés R, Carolina Pastene S, Alejandro Morales P, Bárbara Gutiérrez R, Ana Canales P, Pabla Martínez O, Guido Juarez D, and Rafael Caballero T

Subjects
Streptococcus agalactiae, sepsis neonatal, neonatal sepsis, Gynecology and obstetrics, RG1-991
Abstract

Streptococcus agalactiae es el principal agente bacteriano responsable de la sepsis neonatal. Para evitar la infección perinatal se recomienda su pesquisa en la región vagino-anal durante el tercer trimestre, y tratamiento antibiótico durante el trabajo de parto en las gestantes colonizadas. El objetivo de este estudio es conocer la prevalencia de colonización del Streptococcus agalactie en la población de embarazadas controladas en la maternidad del Hospital Clínico de la Universidad de Chile, en el período comprendido entre el 1 de marzo y el 31 de mayo de 2003. Se tomó cultivo selectivo de Todd Hewitt, entre las 35 y 37 semanas de gestación a 185 embarazadas. Se determinó una prevalencia de colonización vagino-anal de 14,0%Streptococcus agalactiae is the main bacterial agent in neonatal sepsis. To avoid the perinatal infection, a vaginal and anal culture in the third trimester is recommended and then treated with antibiotics during labour. The aim of the study was to study the prevalence of Streptococcus agalactiae in pregnant patients in University of Chile Hospital in Santiago. The study period was from March 1 to May 31 of 2003. Vaginal and anal samples were taken at 35-37 weeks using selective medium (Todd Hewitt broth). A total of 185 patients were studied and the prevalence of streptococcus was 14,0%

Published
2004

40. PREVALENCIA DE COLONIZACION POR STREPTOCOCCUS AGALACTIAE (GRUPO B) EN EL TERCER TRIMESTRE DEL EMBARAZO PESQUISADO EN MEDIO DE CULTIVO NO SELECTIVO

Author

Enrique Valdés R, Carolina Pastene S, T Masumi Grau, Jorge Catalán M, Paula Candia P, Guido Juarez D, and Rafael Caballero T

Subjects
Streptococcus agalactiae, sepsis neonatal, perinatal sepsi, Gynecology and obstetrics, RG1-991
Abstract

El Streptococcus agalactiae es el principal agente bacteriano responsable de sepsis neonatal. Para evitar la infección perinatal se recomienda la pesquisa de la bacteria en región vagino-perianal durante el tercer trimestre, indicando tratamiento antibiótico durante el parto en aquellas gestantes colonizadas. La prevalencia de colonización varía según el tipo de cultivo utilizado (selectivo vs no selectivo). El objetivo de este estudio es conocer la prevalencia de colonización del Streptococcus agalactiae en la población de embarazadas controladas en nuestra maternidad durante los años 2001-2002. Se tomó cultivo en medio no selectivo, entre las 35-37 semanas de gestación a 1658 pacientes, encontrando una prevalencia de colonización vagino-perianal de 6,2%. Esta cifra es bastante menor a la comunicada en otros estudios en embarazadas chilenas, por lo que creemos importante la implementación de medios de cultivos selectivos para mejorar el rendimiento de pesquisaStreptococcus agalactiae is the main bacterial agent in neonatal sepsis. To avoid the perinatal infection, a vaginal and anal culture in the third trimester is recomended and then treated with antibiotics during labour. The prevalence varies depending on the type of culture used (selective vs non selective medium). The aim of our study was to know the prevalence of Streptococcus agalactiae in pregnant women followed in our hospital during 2001-2002. Vaginal and anal samples were taken at 35-37 weeks using non selective medium. We recruited 1658 patients, finding a prevalence of 6.2%. Due to the lower prevalence expected in comparison to other studies in Chilean pregnancies, we believe that the application of selective medium for streptococcal culture may improve results

Published
2003

41. A multi-stakeholder multicriteria decision analysis for the reimbursement of orphan drugs (FinMHU-MCDA study)

Author

de Andrés-Nogales F., Cruz E., Calleja M.Á., Delgado O., Gorgas M.Q., Espín J., Mestre-Ferrándiz J., Palau F., Ancochea A., Arce R., Domínguez-Hernández R., Casado M.Á., Gómez Pajuelo P., Gorgas Torner M.Q., López Andrés A., López Rodríguez M., Marín Ballvé A., Martín Herranz M.I., Morell Baladrón A., Sánchez Martínez F.I., Antoñanzas F., Bonanad S., Caballero T., Cabasés J.M., Cruz J., García-Goñi M., Gil R., Pajuelo P.G., Torner M.Q.G., Andrés A.L., Rodríguez M.L., Ballvé A.M., Herranz M.I.M., Baladrón A.M., Mur C., Machado M.P., Martínez F.I.S., Santos A.R., Suárez M., Trillo J.L., the FinMHU-MCDA Group, Institut Català de la Salut, [de Andrés-Nogales F] Pharmacoeconomics & Outcomes Research Iberia (PORIB), 28224 Pozuelo de Alarcón, Spain. [Cruz E] Asociación Española de Medicamentos Biosimilares, Madrid, Spain. [Calleja MA] Servicio de Farmacia, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Delgado O] Servicio de Farmacia, Hospital Universitario Son Espases, Palma de Mallorca, Spain. [Gorgas MQ] Servei de Farmàcia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Espín J] Escuela Andaluza de Salud Pública, Granada, Spain. Instituto de Investigación Biosanitaria (IBS), Granada, Spain. CIBER de Epidemiología Y Salud Pública (CIBERESP), Madrid, Spain, Vall d'Hebron Barcelona Hospital Campus, [de Andrés-Nogales,F, Domínguez-Hernández,R, Casado,MÁ] Pharmacoeconomics & Outcomes Research Iberia (PORIB), Pozuelo de Alarcón, Madrid, Spain. [Cruz,E] Asociación Española de Medicamentos Biosimilares, Madrid, Spain. [Calleja,MÁ] Servicio de Farmacia, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Delgado,O] Servicio de Farmacia, Hospital Universitario Son Espases, Palma de Mallorca, Spain. Servicio de Farmacia, Hospital Universitari Vall D’Hebron, Barcelona, Spain. [Espín,J] Escuela Andaluza de Salud Pública, Granada, Spain. [Espín,J] Instituto de Investigación Biosanitaria (IBS), Granada, Spain. [Espín,J] CIBER de Epidemiología Y Salud Pública (CIBERESP), Madrid, Spain. [Mestre-Ferrándiz,J] Consultor Económico Independiente, Madrid, Spain. [Mestre-Ferrándiz,J] Madrid, Spain. [Palau,F] Servicio de Medicina Genética y CIBERER, Hospital Universitari Sant Joan de Déu, Hospital Clínic y Universitat de Barcelona, Barcelona, Spain. [Ancochea,A] Federación Española de Enfermedades Raras (FEDER), Madrid, Spain. [Arce,R] Asociación Española de Laboratorios de Medicamentos Huérfanos y Ultrahuérfanos (AELMHU), Barcelona, Spain., and This project was carried out with an unrestricted grant from AELMHU (Aso‑ciación Española de Laboratorios de Medicamentos Huérfanos y Ultrahuér‑fanos). AELMHU was not involved in the design of the study and collection, analysis, and interpretation of data and writing the manuscript

Subjects
Orphan Drug Production, Cost-Benefit Analysis, España, Disease, Psychiatry and Psychology::Psychological Phenomena and Processes::Mental Processes::Thinking::Decision Making [Medical Subject Headings], Other subheadings::Other subheadings::/drug therapy [Other subheadings], fenómenos psicológicos::procesos mentales::pensamiento::toma de decisión [PSIQUIATRÍA Y PSICOLOGÍA], Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], 0302 clinical medicine, afecciones patológicas, signos y síntomas::procesos patológicos::atributos de la enfermedad::enfermedades raras [ENFERMEDADES], Medicine, Pharmacology (medical), 030212 general & internal medicine, Malalties rares - Tractament, Genetics (clinical), Reimbursement, Multinomial logistic regression, Técnicas de apoyo en la toma de decisiones, 030503 health policy & services, General Medicine, Multiple-criteria decision analysis, Rare diseases, tecnología, industria y agricultura::industria::industria fabril::industria farmacéutica::producción de medicamentos huérfanos [TECNOLOGÍA, INDUSTRIA Y AGRICULTURA], 0305 other medical science, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Decision Support Techniques [Medical Subject Headings], medicine.medical_specialty, Decision Making, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Psychological Phenomena::Mental Processes::Thinking::Decision Making [PSYCHIATRY AND PSYCHOLOGY], Medicaments orfes - Cost-eficàcia, Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Rare Diseases [Medical Subject Headings], Decision Support Techniques, Orphan drug, 03 medical and health sciences, Technology and Food and Beverages::Technology, Industry, and Agriculture::Industry::Drug Industry::Orphan Drug Production [Medical Subject Headings], Quality of life (healthcare), Health Care::Health Care Economics and Organizations::Economics::Costs and Cost Analysis::Cost-Benefit Analysis [Medical Subject Headings], Rare Diseases, Orphan drugs, Humans, Humanities::Humanities::Philosophy::Life::Quality of Life [Medical Subject Headings], Technology, Industry, and Agriculture::Industry::Manufacturing Industry::Drug Industry::Orphan Drug Production [TECHNOLOGY, INDUSTRY, AND AGRICULTURE], Adverse effect, Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings], business.industry, Enfermedades raras, Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Rare Diseases [DISEASES], Research, Multicriteria decision analysis, Medicamento huérfano, Mecanismo de reembolso, Spain, Family medicine, Economic evaluation, Quality of Life, business
Abstract

Background Patient access to orphan medicinal products (OMPs) is limited and varies between countries, reimbursement decisions on OMPs are complex, and there is a need for more transparent processes to know which criteria should be considered to inform these decisions. This study aimed to determine the most relevant criteria for the reimbursement of OMPs in Spain, from a multi-stakeholder perspective, and using multicriteria decision analysis (MCDA). Methods An MCDA was developed in 3 phases and included 28 stakeholders closely related to the field of rare diseases (6 physicians, 5 hospital pharmacists, 7 health economists, 4 patient representatives and 6 members from national and regional health authorities). Initially [phase A], a bibliographic review was conducted to identify the potential reimbursement criteria. Then, a reduced advisory board (8 members) proposed, selected, and defined the final list of criteria that could be relevant for reimbursement. A discrete choice experiment (DCE) [phase B] was developed to determine the relevance and relative importance weight of such criteria according to the stakeholders’ preferences by choosing between pairs of hypothetical financing scenarios. A multinomial logit model was fitted to analyze the DCE responses. Finally [phase C], the advisory board review the results using a deliberative process. Results Thirteen criteria were selected, related to 4 dimensions: patient population, disease, treatment, and economic evaluation. Nine criteria were deemed relevant for decision-making and associated with a higher relative importance: Health-related quality of life (HRQL) (23.53%), treatment efficacy (14.64%), availability of treatment alternatives (13.51%), disease severity (12.62%), avoided costs (11.21%), age of target population (7.75%), safety (seriousness of adverse events) (4.72%), quality of evidence (3.82%) and size of target population (3.12%). The remaining criteria had a Conclusion The reimbursement of OMPs in Spain should be determined by its effect on patient’s HRQL, the extent of its therapeutic benefit from efficacy and the availability of other therapeutic options. Furthermore, the severity of the rare disease should also influence the decision along with the potential of the treatment to avoid associated costs.

Published
2021

43. Long-term safety of icatibant treatment of patients with angioedema in real-world clinical practice

Author

Zanichelli, A., Maurer, M., Aberer, W., Caballero, T., Longhurst, H. J., Bouillet, L., Fabien, V., Andresen, I., Grumach, A., Bygum, A., Blanchard Delaunay, C., Boccon-Gibod, I., Coppere, B., Du Thanh, A., Dzviga, C., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Sobel, A., Aygören-Pürsün, E., Bas, M., Bauer, A., Bork, K., Greve, J., Magerl, M., Martinez Saguer, I., Strassen, U., Papadopoulou-Alataki, E., Psarros, F., Graif, Y., Kivity, S., Reshef, A., Toubi, E., Arcoleo, F., Bova, M., Cicardi, M., Manconi, P., Marone, G., Montinaro, V., Triggiani, M., Baeza, L., Cabañas, R., Gala Ortiz, G., Guilarte, M., Hernandez, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Marques, L., Saenz de San Pedro, B., Björkander, J., Bethune, C., Garcez, T., Zanichelli, A., Maurer, M., Aberer, W., Caballero, T., Longhurst, H. J., Bouillet, L., Fabien, V., Andresen, I., Grumach, A., Bygum, A., Blanchard Delaunay, C., Boccon-Gibod, I., Coppere, B., Du Thanh, A., Dzviga, C., Fain, O., Goichot, B., Gompel, A., Guez, S., Jeandel, P., Kanny, G., Launay, D., Maillard, H., Martin, L., Masseau, A., Ollivier, Y., Sobel, A., Aygören-Pürsün, E., Bas, M., Bauer, A., Bork, K., Greve, J., Magerl, M., Martinez Saguer, I., Strassen, U., Papadopoulou-Alataki, E., Psarros, F., Graif, Y., Kivity, S., Reshef, A., Toubi, E., Arcoleo, F., Bova, M., Cicardi, M., Manconi, P., Marone, G., Montinaro, V., Triggiani, M., Baeza, L., Cabañas, R., Gala Ortiz, G., Guilarte, M., Hernandez, D., Hernando de Larramendi, C., Lleonart, R., Lobera, T., Marques, L., Saenz de San Pedro, B., Björkander, J., Bethune, C., and Garcez, T.

Subjects
safety, 0301 basic medicine, real-world, medicine.medical_specialty, Immunology, Brief Communication, Off-label use, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Icatibant, Internal medicine, angioedema, icatibant, Immunology and Allergy, Medicine, Reflux esophagitis, Adverse effect, Pregnancy, Angioedema, business.industry, real‐world, medicine.disease, 030104 developmental biology, 030228 respiratory system, chemistry, Anesthesia, Observational study, Long term safety, medicine.symptom, business
Abstract

The Icatibant Outcome Survey (IOS) is an observational study monitoring safety and effectiveness of icatibant in the real‐world setting. We analyzed safety data from 3025 icatibant‐treated attacks in 557 patients (enrolled between July 2009 and February 2015). Icatibant was generally well tolerated. Excluding off‐label use and pregnancy, 438 patients (78.6%) did not report adverse events (AEs). The remaining 119 (21.4%) patients reported 341 AEs, primarily gastrointestinal disorders (19.6%). Of these, 43 AEs in 17 patients (3.1%) were related to icatibant. Serious AEs (SAEs) occurred infrequently. A total of 143 SAEs occurred in 59 (10.6%) patients; only three events (drug inefficacy, gastritis, and reflux esophagitis) in two patients were considered related to icatibant. Notably, no SAEs related to icatibant occurred in patients with cardiovascular disease, nor in those using icatibant at a frequency above label guidelines. Additionally, no major differences were noted in AEs occurring in on‐label vs off‐label icatibant users.

Published
2017
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49. PD-L1 testing based on SP142 antibody in metastatic triple-negative breast cancer: summary of an expert round-table discussion

Author

Peg V, Lopez-Garcia M, Comerma L, Peiro G, Garcia-Caballero T, Lopez A, Suarez-Gauthier A, Ruiz I, and Rojo F

Subjects
PD-L1, breast cancer, diagnosis, antibody, immunohistochemistry, immunotherapy
Abstract

Triple-negative breast cancer (TNBC) is more aggressive than other breast cancer subtypes. TNBC is characterized by increased expression of Programmed Death-ligand 1 (PD-L1), a signal used by many tumors to escape the immune response. Expression of PD-L1 is a positive predictor of response to immunotherapy; therefore, it should be investigated in TNBC in order to select patients who may benefit from anti-PD-L1 therapies. While many PD-L1 assays are available, only the VENTANA platform with the anti-PD-L1 (SP142) antibody is licensed as a companion diagnostic device for selecting patients with metastatic/advanced TNBC who are candidates for treatment with atezolizumab. In this article, we provide a summary of an expert round-table discussion about PD-L1 testing, using the SP142 antibody in metastatic TNBC. Lay abstract Triple negative breast cancer (TNBC) is the most aggressive breast cancer subtype. Recent discoveries in TNBC have shown that the higher the expression of the surface molecule PD-L1 in the cancer cells, the better the response of patients to immunotherapy. While several tests or diagnostics assays for detecting PD-L1 exist, only the antibody anti-PD-L1 SP142 possesses proven diagnostic value for selecting metastatic TNBC patients eligible for atezolizumab immunotherapy. Throughout the present article, a group of experts discusses how to best carry out the assessment of PD-L1 status with this assay.

Published
2021

50. Hereditary angioedema due to C1 inhibitor deficiency: real-world experience from the Icatibant Outcome Survey in Spain

Author

Guilarte M, Sala-Cunill A, Baeza ML, Cabañas R, Hernández MD, Ibañez E, de Larramendi CH, Lleonart R, Lobera T, Marqués L, de San Pedro BS, Botha J, Andresen I, Caballero T, and IOS Study Group

Subjects
Spain, Hereditary angioedema, Registries, Bradykinin, Icatibant, Bradykinin B2 receptor antagonists, On-demand treatment, Bradykinin B-2 receptor antagonists
Abstract

BACKGROUND: The Icatibant Outcome Survey (IOS) is an international registry monitoring the use of icatibant, a bradykinin B(2) receptor antagonist indicated for the acute treatment of hereditary angioedema (HAE) attacks. Our goal was to assess disease characteristics and icatibant treatment outcomes in patients with HAE due to C1 inhibitor deficiency (HAE type 1 or 2 (HAE-1/2)) from Spain relative to other countries participating in IOS. METHODS: Descriptive retrospective analyses of data are reported from 10 centers in Spain vs 51 centers in 12 other participating countries (July 2009 to January 2019). RESULTS: No meaningful differences were identified between patients in Spain (n = 119) and patients across other countries (n = 907) regarding median age at symptom onset (15.0 vs 12.0 years) or diagnosis (22.3 vs 20.5 years). Overall HAE attack rates (total attacks/total years of follow-up) were 2.66 in Spain and 1.46 across other countries. Patients in Spain reported fewer severe/very severe HAE attacks before treatment (41.0% vs 45.9%; P < 0.0001) and, for icatibant-treated attacks, longer median time to treatment (2.9 vs 1.0 h), time to attack resolution (18.0 vs 5.5 h), and total attack duration (24.6 vs 8.0 h). Use of androgens for long-term prophylaxis was higher in Spain (51.2% vs 26.7%). CONCLUSION: Patients with HAE-1/2 in Spain reported fewer severe/very severe attacks, administered icatibant later, and had longer-lasting attacks than did patients across other countries in IOS. These differences may indicate varying disease management practices (e.g., delayed icatibant treatment) and reporting. Efforts to raise awareness on the benefits of early on-demand treatment may be warranted. TRIAL REGISTRATION: NCT01034969.

Published
2021

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