Thursday, April 7, 2011

Dabigatran for anticoagulation in Afib

Dabigatran is an oral, direct thrombin inhibitor. Its efficacy and safety relative to warfarin was evaluated in the RE-LY trial, at 2 doses. It was the first randomized trial to demonstrate that an alternative oral anticoagulant is superior to adjusted-dose warfarin. Over 18,000 patients with non-valvular atrial fibrillation and at least 1 stroke risk factor were were randomly assigned to receive oral dabigatran at one of two doses (110 or 150 mg) twice daily, or adjusted dose warfarin (INR 2-3). The primary study outcome was stroke or systemic embolism. After a median follow-up 2 years, rates of the primary outcome were 1.69%/yr in the warfarin group, compared with 1.53%/yr in the group that received 110 mg of dabigatran (P<0.001), and 1.11%/yr in the group that received 150 mg of dabigatran (P<0.001). The rate of major bleeding was higher in the warfarin group, compared to the lower dose dabigatran group. This study concluded that 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. To see the full article click here http://www.nejm.org/doi/full/10.1056/NEJMoa0905561#t=article

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