Repositorio UFRO · Omeka S

Global Prospective Safety Analysis of Rivaroxaban

Primer Autor	Kirchhof, Paulus
Co-autores	Radaideh, Ghazi Kim, Young-Hoon Lanas, Fernando Haas, Sylvia Amarenco, Pierre Turpie, Alexander G. G. Bach, Miriam Lambelet, Marc Hess, Susanne Camm, A. John
Título	Global Prospective Safety Analysis of Rivaroxaban
Editorial	ELSEVIER SCIENCE INC
Revista	JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Lenguaje	en
Resumen	BACKGROUND The efficacy of direct oral anticoagulants (DOACs) for stroke prevention in patients with atrial fibrillation (AF) has been established in clinical trials. However, well-conducted, prospective, real-world observational studies of the safety and effectiveness of DOACs are needed. OBJECTIVES This study sought to assess the real-world safety profile of rivaroxaban through a pooled analysis of patients with AF enrolled in the XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation) program worldwide. METHODS A pre-planned pooled analysis of the XANTUS, XANAP (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia), and XANTUS-EL (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latin America and EMEA Region) registries was performed. Patients with AF newly starting rivaroxaban for stroke prevention were followed for 1 year. Primary outcomes were treatment-emergent major bleeding, adverse events (AEs)/serious AEs, and all-cause death. Secondary outcomes included treatment-emergent thromboembolic events and nonmajor bleeding. Major outcomes were centrally adjudicated. RESULTS Overall, 11,121 patients were included (mean age 70.5 +/- 10.5 years, female 42.9%). Comorbidities included heart failure (21.2%), hypertension (76.2%), and diabetes (22.3%). Event rates were: events/100 patient-years: major bleeding 1.7 (95% confidence interval [CI]: 1.5 to 2.0, lowest: Latin America 0.7, highest: Western Europe, Canada, and Israel 2.3), all-cause death 1.9 (95% CI: 1.6 to 2.2, lowest: Eastern Europe 1.5, highest: Latin America, Middle East, and Africa 2.7), and stroke or systemic embolism 1.0 (95% CI: 0.8 to 1.2, lowest: Latin America 0, highest: East Asia 1.8). One-year treatment persistence was 77.4% (lowest: East Asia 66.4%, highest: Eastern Europe 84.4%). CONCLUSIONS This large, prospective, real-world analysis in 11,121 patients from 47 countries showed low bleeding and stroke rates in rivaroxaban-treated patients with AF, with low treatment discontinuation in different regions of the world. Results were broadly consistent across regions. (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation [XANTUS], NCT01606995, Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latin America and EMEA Region [XANTUS-EL], NCT01800006, and Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia [XANAP], NCT01750788) (J Am Coll Cardiol 2018, 72: 141-53) (C) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. ANTECEDENTES La eficacia de los anticoagulantes orales directos (ACOD) para la prevención del ictus en pacientes con fibrilación auricular (FA) se ha establecido en ensayos clínicos. Sin embargo, se necesitan estudios observacionales prospectivos, bien realizados y en el mundo real sobre la seguridad y la eficacia de los ACOD. OBJETIVOS Este estudio buscó evaluar el perfil de seguridad en el mundo real de rivaroxabán a través de un análisis agrupado de pacientes con FA inscritos en el programa XANTUS (Xarelto para la prevención del ictus en pacientes con fibrilación auricular) en todo el mundo. MÉTODOS Se realizó un análisis agrupado planificado previamente de los registros XANTUS, XANAP (Xarelto para la prevención del ictus en pacientes con fibrilación auricular en Asia) y XANTUS-EL (Xarelto para la prevención del ictus en pacientes con fibrilación auricular en Latinoamérica y la región EMEA). Se realizó un seguimiento durante 1 año de los pacientes con FA que comenzaron recientemente con rivaroxabán para la prevención del ictus. Los resultados primarios fueron hemorragia mayor relacionada con el tratamiento, eventos adversos (EA)/EA graves y muerte por cualquier causa. Los resultados secundarios incluyeron eventos tromboembólicos relacionados con el tratamiento y hemorragias no mayores. Los resultados principales se adjudicaron de forma centralizada. RESULTADOS: Se incluyeron 11.121 pacientes (edad media: 70,5 ± 10,5 años, 42,9 mujeres). Las comorbilidades incluyeron insuficiencia cardíaca (21,2%), hipertensión (76,2%) y diabetes (22,3%). Las tasas de eventos fueron: eventos/100 pacientes-año: hemorragia mayor 1,7 (intervalo de confianza [IC] del 95 %: 1,5 a 2,0 mínima: Latinoamérica 0,7 máxima: Europa Occidental, Canadá e Israel 2,3) muerte por cualquier causa 1,9 (IC del 95 %: 1,6 a 2,2 mínima: Europa Oriental 1,5 máxima: Latinoamérica, Oriente Medio y África 2,7) y accidente cerebrovascular o embolia sistémica 1,0 (IC del 95 %: 0,8 a 1,2 mínima: Latinoamérica 0 máxima: Asia Oriental 1,8). La persistencia del tratamiento a un año fue del 77,4 % (mínima: Asia Oriental 66,4 % máxima: Europa Oriental 84,4 %). CONCLUSIONES Este gran análisis prospectivo del mundo real en 11.121 pacientes de 47 países mostró bajas tasas de sangrado y accidente cerebrovascular en pacientes con FA tratados con rivaroxabán, con baja interrupción del tratamiento en diferentes regiones del mundo. Los resultados fueron ampliamente consistentes en todas las regiones. (Xarelto para la prevención del accidente cerebrovascular en pacientes con fibrilación auricular [XANTUS], NCT01606995, Xarelto para la prevención del accidente cerebrovascular en pacientes con fibrilación auricular en Latinoamérica y la región EMEA [XANTUS-EL], NCT01800006, y Xarelto para la prevención del accidente cerebrovascular en pacientes con fibrilación auricular en Asia [XANAP], NCT01750788) (J Am Coll Cardiol 2018, 72: 141-53) (C) 2018 Los autores. Publicado por Elsevier en nombre de la American College of Cardiology Foundation.
Tipo de Recurso	Artículo original
Description	El programa de investigación XANTUS fue financiado por Bayer. El Dr. Kirchhof ha recibido apoyo para su investigación de la Unión Europea, la Fundación Británica del Corazón, la Fundación Leducq, el Consejo de Investigación Médica (Reino Unido), el Centro Alemán de Investigación Cardiovascular, 3M Medica, MEDA Pharma, AstraZeneca, Bayer HealthCare, Biosense Webster, Boehringer Ingelheim, Daiichi-Sankyo, la Sociedad Alemana de Cardiología, Medtronic, Merck Sharp & Dohme, Otsuka Pharma, Pfizer/Bristol-Myers Squibb, Sanofi, Servier, Siemens y Takeda. Además, ha recibido honorarios de varias de estas empresas y figura como inventor de dos patentes pendientes de la Universidad de Birmingham (Terapia de Fibrilación Auricular WO 2015140571, Marcadores de Fibrilación Auricular WO 2016012783). El Dr. Radaideh ha recibido honorarios y honorarios por consultoría de Bayer, Sanofi, Merck Sharp & Dohme, Takeda y Servier. El Dr. Lanas ha sido consultor para Bayer, Boehringer Ingelheim, Bristol-Myers Squibb y Pfizer. El Dr. Haas ha sido consultor para Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Pfizer y Sanofi. El Dr. Amarenco ha sido consultor para Boehringer Ingelheim, Edwards, GlaxoSmithKline, Lundbeck, Medtronic, Merck, ShingPoon y Kowa Pharmaceutical, ha sido miembro del comité ejecutivo de AstraZeneca, Bayer y Pfizer: ha formado parte del Comité de Monitoreo de Seguridad de Datos de Fibrogen, ha formado parte de los consejos asesores de Bristol-Myers Squibb y Daiichi-Sankyo, y ha recibido subvenciones de AstraZeneca, Bristol-Myers Squibb, Boston Scientific, Pfizer y Sanofi. El Dr. Turpie ha sido consultor para Bayer, Janssen Pharmaceutical Research & Development y Portola. Los Dres. Bach y Hess son empleados de Bayer AG. El Dr. Bach posee acciones de Bayer AG. El Sr. Lambelet es empleado de Chrestos Concept, empresa que recibió financiación de Bayer AG para este análisis. El Dr. Camm ha sido consultor para Aryx, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Johnson & Johnson, Pfizer y Sanofi, y ha recibido subvenciones de Bayer, Boehringer Ingelheim y Daiichi-Sankyo. El Dr. Kim ha declarado no tener ninguna relación relevante con el contenido de este documento que deba declarar. The XANTUS research programme was funded by Bayer. Dr. Kirchhof has received research support from the European Union, the British Heart Foundation, the Leducq Foundation, the Medical Research Council (U.K.), the German Centre for Cardiovascular Research, 3M Medica, MEDA Pharma, AstraZeneca, Bayer HealthCare, Biosense Webster, Boehringer Ingelheim, Daiichi-Sankyo, German Cardiac Society, Medtronic, Merck Sharp & Dohme, Otsuka Pharma, Pfizer/Bristol-Myers Squibb, Sanofi, Servier, Siemens, and Takeda, has received honoraria from several such companies, and is listed as an inventor on 2 pending patents held by the University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). Dr. Radaideh has received consulting fees and honoraria from Bayer, Sanofi, Merck Sharp & Dohme, Takeda, and Servier. Dr. Lanas has been a consultant for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Pfizer. Dr. Haas has been a consultant for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Pfizer, and Sanofi. Dr. Amarenco has been a consultant for Boehringer Ingelheim, Edwards, GlaxoSmithKline, Lundbeck, Medtronic, Merck, ShingPoon, and Kowa Pharmaceutical, has served as an executive committee member for AstraZeneca, Bayer, and Pfizer: has served on the Data Safety Monitoring Board for Fibrogen, has served on the advisory boards for Bristol-Myers Squibb and Daiichi-Sankyo, and has received grants from AstraZeneca, Bristol-Myers Squibb, Boston Scientific, Pfizer, and Sanofi. Dr. Turpie has been a consultant for Bayer, Janssen Pharmaceutical Research & Development, and Portola. Drs. Bach and Hess are employees of Bayer AG. Dr. Bach holds stock in Bayer AG. Mr. Lambelet is an employee of Chrestos Concept, which received funding for this analysis from Bayer AG. Dr. Camm has been a consultant for Aryx, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Johnson & Johnson, Pfizer, and Sanofi, and has received grants from Bayer, Boehringer Ingelheim, and Daiichi-Sankyo. Dr. Kim has reported that he has no relationships relevant to the contents of this paper to disclose.
doi	10.1016/j.jacc.2018.04.058
Formato Recurso	pdf
Palabras Claves	atrial fibrillation real-world rivaroxaban safety stroke prevention XANTUS fibrilación auricular mundo real rivaroxabán seguridad prevención de accidentes cerebrovasculares XANTO
Ubicación del archivo	http://dx.doi.org/10.1016/j.jacc.2018.04.058
Categoría OCDE	Cardiac & Cardiovascular Systems
Materias	atrial fibrillation real-world rivaroxaban safety stroke prevention XANTUS fibrilación auricular mundo real rivaroxabán seguridad prevención de accidentes cerebrovasculares XANTO
Disciplinas de la OCDE	Sistema Cardiovascular y Cardiaco Farmacología y Farmacia Medicina General e Interna
Versión del recurso (Recomendado-único)	version publicada
Tipo de ruta	hibrida verde
Access Rights	acceso abierto
Derechos de acceso	acceso abierto
Id de Web of Science	WOS:000437218000003
Título de la cita (Recomendado-único)	Global Prospective Safety Analysis of Rivaroxaban
Identificador del recurso (Mandatado-único)	Artículo original
Editorial	ELSEVIER SCIENCE INC
Revista/Libro	JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Categoría WOS	Sistemas cardíacos y cardiovasculares
ISSN	0735-1097
Idioma	en
Referencia del Financiador (Mandatado si es aplicable-repetible)	Bayer European Union British Heart Foundation Leducq Foundation Medical Research Council (U.K.) German Centre for Cardiovascular Research 3M Medica MEDA Pharma AstraZeneca Bayer HealthCare Biosense Webster Boehringer Ingelheim Daiichi-Sankyo German Cardiac Society Medtronic Merck Sharp Dohme Otsuka Pharma Pfizer/Bristol-Myers Squibb Sanofi Servier Siemens Takeda Bristol-Myers Squibb Boston Scientific Pfizer Bayer AG
Descripción	The XANTUS research programme was funded by Bayer. Dr. Kirchhof has received research support from the European Union, the British Heart Foundation, the Leducq Foundation, the Medical Research Council (U.K.), the German Centre for Cardiovascular Research, 3M Medica, MEDA Pharma, AstraZeneca, Bayer HealthCare, Biosense Webster, Boehringer Ingelheim, Daiichi-Sankyo, German Cardiac Society, Medtronic, Merck Sharp & Dohme, Otsuka Pharma, Pfizer/Bristol-Myers Squibb, Sanofi, Servier, Siemens, and Takeda, has received honoraria from several such companies, and is listed as an inventor on 2 pending patents held by the University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). Dr. Radaideh has received consulting fees and honoraria from Bayer, Sanofi, Merck Sharp & Dohme, Takeda, and Servier. Dr. Lanas has been a consultant for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, and Pfizer. Dr. Haas has been a consultant for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Pfizer, and Sanofi. Dr. Amarenco has been a consultant for Boehringer Ingelheim, Edwards, GlaxoSmithKline, Lundbeck, Medtronic, Merck, ShingPoon, and Kowa Pharmaceutical, has served as an executive committee member for AstraZeneca, Bayer, and Pfizer: has served on the Data Safety Monitoring Board for Fibrogen, has served on the advisory boards for Bristol-Myers Squibb and Daiichi-Sankyo, and has received grants from AstraZeneca, Bristol-Myers Squibb, Boston Scientific, Pfizer, and Sanofi. Dr. Turpie has been a consultant for Bayer, Janssen Pharmaceutical Research & Development, and Portola. Drs. Bach and Hess are employees of Bayer AG. Dr. Bach holds stock in Bayer AG. Mr. Lambelet is an employee of Chrestos Concept, which received funding for this analysis from Bayer AG. Dr. Camm has been a consultant for Aryx, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Johnson & Johnson, Pfizer, and Sanofi, and has received grants from Bayer, Boehringer Ingelheim, and Daiichi-Sankyo. Dr. Kim has reported that he has no relationships relevant to the contents of this paper to disclose.
Formato	pdf
License	CC BY-NC-ND 4.0
Página de inicio (Recomendado-único)	141
Página final (Recomendado-único)	153
Condición de la licencia (Recomendado-repetible)	CC BY-NC-ND 4.0
Entidad financiadora	Bayer#European Union# British Heart Foundation#Leducq Foundation# Medical Research Council (U.K.)#German Centre for Cardiovascular Research#3M Medica#MEDA Pharma#AstraZeneca#Bayer HealthCare#Biosense Webster#Boehringer Ingelheim#Daiichi-Sankyo#German Cardiac Society#Medtronic#Merck Sharp Dohme#Otsuka Pharma#Pfizer/Bristol-Myers Squibb#Sanofi#Servier#Siemens#Takeda#Bristol-Myers Squibb#Boston Scientific#Pfizer#Bayer AG