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

共 12 条

[1] Additional Events in the RE-LY Trial
Connolly, Stuart J.
Wallentin, Lars
Yusuf, Salim
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 2014, 371 (15) : 1464 - 1465
[2] Dabigatran versus Warfarin in Patients with Atrial Fibrillation.
Connolly, Stuart J.
Ezekowitz, Michael D.
Yusuf, Salim
Eikelboom, John
Oldgren, Jonas
Parekh, Amit
Pogue, Janice
Reilly, Paul A.
Themeles, Ellison
Varrone, Jeanne
Wang, Susan
Alings, Marco
Xavier, Denis
Zhu, Jun
Diaz, Rafael
Lewis, Basil S.
Darius, Harald
Diener, Hans-Christoph
Joyner, Campbell D.
Wallentin, Lars
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 2009, 361 (12) : 1139 - 1151
[3] STANDARD DISTANCE IN UNIVARIATE AND MULTIVARIATE-ANALYSIS
FLURY, BK
RIEDWYL, H
[J]. AMERICAN STATISTICIAN, 1986, 40 (03) : 249 - 251
[4] Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation
Graham, David J.
Reichman, Marsha E.
Wernecke, Michael
Hsueh, Hui
Izem, Rima
Southworth, Mary Ross
Wei, Yuqin
Liao, Jiemin
Goulding, Margie R.
Mott, Katrina
Chillarige, Yoganand
MaCurdy, Thomas E.
Worrall, Chris
Kelman, Jeffrey A.
[J]. JAMA INTERNAL MEDICINE, 2016, 176 (11) : 1662 - 1671
[5] Cardiovascular, Bleeding, and Mortality Risks in Elderly Medicare Patients Treated With Dabigatran or Warfarin for Nonvalvular Atrial Fibrillation
Graham, David J.
Reichman, Marsha E.
Wernecke, Michael
Zhang, Rongmei
Southworth, Mary Ross
Levenson, Mark
Sheu, Ting-Chang
Mott, Katrina
Goulding, Margie R.
Houstoun, Monika
MaCurdy, Thomas E.
Worrall, Chris
Kelman, Jeffrey A.
[J]. CIRCULATION, 2015, 131 (02) : 157 - 164
[6] Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: A global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation
Huisman, Menno V.
Lip, Gregory Y. H.
Diener, Hans C.
Dubner, Sergio J.
Halperin, Jonathan L.
Ma, Chang S.
Rothman, Kenneth J.
Teutsch, Christine
Zint, Kristina
Ackermann, Diana
Clemens, Andreas
Bartels, Dorothee B.
[J]. AMERICAN HEART JOURNAL, 2014, 167 (03) : 329 - 334
[7] Bleeding Events Among New Starters and Switchers to Dabigatran Compared with Warfarin in Atrial Fibrillation
Larsen, Torben Bjerregaard
Gorst-Rasmussen, Anders
Rasmussen, Lars Hvilsted
Skjoth, Flemming
Rosenzweig, Mary
Lip, Gregory Y. H.
[J]. AMERICAN JOURNAL OF MEDICINE, 2014, 127 (07) : 650 - +
[8] Myocardial Ischemic Events in 'Real World' Patients with Atrial Fibrillation Treated with Dabigatran or Warfarin
Larsen, Torben Bjerregaard
Rasmussen, Lars Hvilsted
Gorst-Rasmussen, Anders
Skjoth, Flemming
Rosenzweig, Mary
Lane, Deirdre A.
Lip, Gregory Y. H.
[J]. AMERICAN JOURNAL OF MEDICINE, 2014, 127 (04) : 329 - +
[9] Lash T.L., 2010, Applying Quantitative Bias Analysis to Epidemiologic Data
[10] Patient outcomes using the European label for dabigatran A post-hoc analysis from the RE-LY database
Lip, Gregory Y. H.
Clemens, Andreas
Noack, Herbert
Ferreira, Jorge
Connolly, Stuart J.
Yusuf, Salim
[J]. THROMBOSIS AND HAEMOSTASIS, 2014, 111 (05) : 933 - 942

← 1 2 →