Efficacy and safety of dabigatran etexilate and warfarin in ‘real world’ patients with atrial fibrillation: A prospective nationwide cohort study ONLINE FIRST

J Am Coll Cardiology: April 1, 2013

Objective  To assess the efficacy and safety in an ‘everyday clinical practice’ population of anticoagulant-naïve patients with atrial fibrillation (AF) treated with dabigatran etexilate following its post-approval availability in Denmark, compared to warfarin.

Background  Concerns have been raised about an excess of bleeding events or myocardial infarction amongst patients treated with the new oral direct thrombin inhibitor, dabigatran etexilate.

Methods  From the Danish Registry of Medicinal Product Statistics, we identified a dabigatran-treated group and a 1:2 propensity matched warfarin-treated group of n=4978and n=8936, respectively. Comparisons on efficacy and safety outcomes were made based on Cox-proportional hazards models stratified on propensity match groups. Read more

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