Safety and effectiveness of dabigatran at 2 years: Final outcomes from Phase II of the GLORIA-AF registry program

被引：21

作者：

Mazurek, Michal ^{[1
]}

Teutsch, Christine ^{[2
]}

Diener, Hans-Christoph ^{[3
]}

Dubner, Sergio J. ^{[4
]}

Halperin, Jonathan L. ^{[5
]}

Ma, Chang-Sheng ^{[6
]}

Rothman, Kenneth J. ^{[7
]}

Paquette, Miney ^{[8
]}

Zint, Kristina ^{[9
]}

Franca, Lionel Riou ^{[10
]}

Lu, Shihai ^{[11
]}

Bartels, Dorothee B. ^{[12
]}

Huisman, Menno V. ^{[13
]}

Lip, Gregory Y. H. ^{[14
,15
]}

机构：

[1] Silesian Med Univ, Congenital Heart Dis & Electrotherapy, Dept Cardiol, Silesian Ctr Heart Dis, Zabrze, Poland

[2] Boehringer Ingelheim Int GmbH, Therapeut Area Cardiometab, Dept Clin Dev & Med Affairs, Ingelheim, Germany

[3] Univ Duisburg Essen, Dept Neurol, Essen, Germany

[4] Clin & Maternidad Suizo Argentina, Buenos Aires, DF, Argentina

[5] Icahn Sch Med Mt Sinai, New York, NY 10029 USA

[6] Capital Med Univ, Beijing AnZhen Hosp, Atrial Fibrillat Ctr, Cardiol Dept, Beijing, Peoples R China

[7] RTI Hlth Solut, Res Triangle Pk, NC USA

[8] Boehringer Ingelheim GmbH & Co KG, Dept Med, Burlington, ON, Canada

[9] Boehringer Ingelheim Int GmbH, Global Epidemiol Dept, Ingelheim, Germany

[10] Sanofi Aventis, Chilly Mazarin, France

[11] Boehringer Ingelheim Pharmaceut Inc, Biostat & Data Sci Dept, 90 E Ridge POB 368, Ridgefield, CT 06877 USA

[12] Hannover Med Sch, Hannover, Germany

[13] Leiden Univ, Med Ctr, Dept Thrombosis & Hemostasis, Leiden, Netherlands

[14] Univ Liverpool, Liverpool Ctr Cardiovasc Sci, Liverpool, Merseyside, England

[15] Liverpool Heart & Chest Hosp, Liverpool, Merseyside, England

来源：

AMERICAN HEART JOURNAL | 2019年 / 218卷

关键词：

ATRIAL-FIBRILLATION; MORTALITY RISKS; WARFARIN; STROKE; EVENTS;

D O I：

10.1016/j.ahj.2019.08.012

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

GLORIA-AF is a large, ongoing, prospective, global registry program run in 3 phases, assessing long-term safety and effectiveness of dabigatran etexilate (dabigatran) in patients with newly diagnosed atrial fibrillation (AF) in clinical practice. This report provides the final analysis of 2-year clinical outcomes of the full cohort of 4873 patients prescribed dabigatran and followed for a mean of 18.0 +/- 9.4 months out of the 15,308 eligible patients enrolled in Phase II (2011-2014). The overall incidence rates per 100 person-years were: stroke 0.65 (95% CI 0.48-0.87), major bleeding 0.97 (0.76-1.23) and myocardial infarction (MI) 0.50 (0.35.0.69), with observed event rates broadly consistent in all study regions, which confirms the sustained safety and effectiveness of dabigatran over 2 years of observation in clinical practice.

引用

页码：123 / 127

页数：5

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