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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Dabigatran versus warfarin in patients with atrial fibrillation
New England Journal of Medicine, Volume 361, No. 12, Year 2009
Notification
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Description
BACKGROUND: Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. METHODS: In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran - 110 mg or 150 mg twice daily - or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. RESULTS: Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051). CONCLUSIONS: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.) Copyright © 2009 Massachusetts Medical Society.
Authors & Co-Authors
Connolly, Stuart J.
Canada, Hamilton
Hamilton Health Sciences
Ezekowitz, Michael D.
United States, Wynnewood
Lankenau Institute for Medical Research
Yusuf, Salim N.
Canada, Hamilton
Hamilton Health Sciences
Eikelboom, John W.
Canada, Hamilton
Hamilton Health Sciences
Oldgren, Jonas S.
Sweden, Uppsala
Uppsala Clinical Research Center
Pogue, Janice M.
Canada, Hamilton
Hamilton Health Sciences
Reilly, Paul A.
United States, Ridgefield
Boehringer Ingelheim Pharmaceuticals, Inc.
Themeles, Ellison
Canada, Hamilton
Hamilton Health Sciences
Alings, Marco A.
Netherlands, Utrecht
Working Group on Cardiovascular Research the Netherlands
Xavier, Denis
India, Bengaluru
St. John's National Academy of Health Sciences India
Zhu, Jun
Unknown Affiliation
Díaz, Rafaël J.
Argentina, Rosario
Estudios Clínicos Latinoamérica, Argentina
Lewis, Basil S.
Israel, Haifa
Carmel Medical Center
Darius, Harald
Germany, Berlin
Vivantes Klinikum Neukölln
Diener, Hans Christoph W.
Germany, Duisburg
Universität Duisburg-essen
Joyner, Campbell D.
Canada, Toronto
Sunnybrook Health Sciences Centre
Wallentin, Lars
Sweden, Uppsala
Uppsala Clinical Research Center
Amerena, John V.
Unknown Affiliation
Avezum, Álvaro Jr
Unknown Affiliation
Brugada, Josep
Unknown Affiliation
Budaj, Andrzej J.
Unknown Affiliation
Commerford, Patrick Joseph
Unknown Affiliation
Dans, Antonio L.L.
Unknown Affiliation
Di Pasquale, Giuseppe And
Unknown Affiliation
Erol, C.
Unknown Affiliation
Ferreira, Jorge S.
Unknown Affiliation
Flaker, Greg C.
Unknown Affiliation
Flather, Marcus D.
Unknown Affiliation
Franzosi, Maria Grazia
Unknown Affiliation
Golitsyn, Sergey P.
Unknown Affiliation
González-Hermosillo, Jesús Antonio
Unknown Affiliation
Halon, David A.
Unknown Affiliation
Heidbuchel, H.
Unknown Affiliation
Hohnloser, Stefan Hans
Unknown Affiliation
Hori, Masatusugu
Unknown Affiliation
Huber, Kurt H.
Unknown Affiliation
Janský, Petr
Unknown Affiliation
Kamenský, Gabriel
Unknown Affiliation
Keltai, Mátyás
Unknown Affiliation
Lau, Chu Pak
Unknown Affiliation
Le-Heuzey, Jean Yves F.
Unknown Affiliation
Liu, Lisheng
Unknown Affiliation
Pais, Prem S.
Unknown Affiliation
Parkhomenko, Alexander N.
Unknown Affiliation
Piegas, Leopoldo Soares Oares
Unknown Affiliation
Raev, Dimitar H.
Unknown Affiliation
Talajic, Mario R.
Unknown Affiliation
Tan, Ru San
Unknown Affiliation
Tanomsup, Supachai
Unknown Affiliation
Toivonen, Lauri K.
Unknown Affiliation
Vinereanu, Dragoș
Unknown Affiliation
Statistics
Citations: 9,317
Authors: 51
Affiliations: 11
Identifiers
Doi:
10.1056/NEJMoa0905561
ISSN:
00284793
Research Areas
Health System And Policy
Noncommunicable Diseases
Study Design
Cohort Study