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FDA approval of a drug is not usually sufficient impetus for a Journal Watch Top Story of the year. An exception to this informal policy is the recent approval of dabigatran (Pradaxa) for stroke prophylaxis in patients with atrial fibrillation, because it portends the eventual decline of warfarin, a notoriously frustrating drug to manage. Dabigatran is an oral thrombin inhibitor that does not require international normalized ratio (INR) monitoring (JW Gen Med Oct 28 2010).
FDA approval was based on the RE-LY trial, in which 18,000 participants were randomized to one of two twice-daily doses of dabigatran (110 or 150 mg) or dose-adjusted warfarin and were followed for a median of 2 years. Annual risk for systemic embolism or stroke was 1.7% i…