Repositorio
Institucional

Kirchhof, Paulus

Radaideh, Ghazi#Kim, Young-Hoon#Lanas, Fernando#Haas, Sylvia#Amarenco, Pierre#Turpie, Alexander G. G.#Bach, Miriam#Lambelet, Marc#Hess, Susanne#Camm, A. John

Global Prospective Safety Analysis of Rivaroxaban

ELSEVIER SCIENCE INC

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

en

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.

Artículo original

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.

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.

10.1016/j.jacc.2018.04.058

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atrial fibrillation# real-world# rivaroxaban# safety# stroke prevention# XANTUS

http://dx.doi.org/10.1016/j.jacc.2018.04.058

Cardiac & Cardiovascular Systems

fibrilación auricular# mundo real# rivaroxabán# seguridad# prevención de accidentes cerebrovasculares# XANTO

Sistema Cardiovascular y Cardiaco

Farmacología y Farmacia

Medicina General e Interna

WOS:000437218000003

Global Prospective Safety Analysis of Rivaroxaban

Artículo original

version publicada

ELSEVIER SCIENCE INC

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Sistemas cardíacos y cardiovasculares

0735-1097

en

European Union#British Heart Foundation#Leducq Foundation#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#Takeda#University of Birmingham WO 2015140571#University of Birmingham WO 2016012783#Bayer#Edwards#GlaxoSmithKline#Lundbeck#Medtronic#Merck#ShingPoon#Kowa Pharmaceutical#Bristol-Myers Squibb,#Boston Scientific#Janssen Pharmaceutical Research & Development##Bayer AG. #Aryx#Daiichi-Sankyo#Johnson & Johnson

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

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.

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