Cardiovascular outcomes during treatment with dabigatran: comprehensive analysis of individual subject data by treatment.

ABSTRACT:

Background

Dabigatran 150 mg twice daily was shown to be superior to warfarin in preventing stroke in subjects with nonvalvular atrial fibrillation (SPAF) in the RE-LY (Randomized Evaluation of Long-term anticoagulation therapY) trial. Numerically, more myocardial infarctions occurred in patients receiving dabigatran compared with well-controlled warfarin. This observation prompted a comprehensive analysis of cardiovascular outcomes, including myocardial infarction, in all completed Phase II and III trials of dabigatran etexilate.

Methods

The analysis included comparisons of dabigatran with warfarin, enoxaparin, and placebo. Data were analyzed for the occurrence of cardiovascular events from 14 comparative trials (n = 42,484) in five different indications. Individual study d

SUBMITTER: Clemens A 

PROVIDER: S-EPMC3798206 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature