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On October 19, 2010, dabigatran (Pradaxa; an oral thrombin inhibitor) was approved by the FDA to lower risk for thrombus and stroke in patients with atrial fibrillation. Unlike warfarin, dabigatran is given in fixed twice-daily doses and does not require international normalized ratio (INR) monitoring. The approval comes on the heels of the RE-LY trial, in which >18,000 people were randomized to one of two twice-daily doses of dabigatran (110 mg or 150 mg) or to dose-adjusted warfarin and were followed for a median of 2 years (JW Neurol Dec 8 2009).
In RE-LY, risk for systemic embolism or stroke was 1.7% in the warfarin group, 1.5% in the 110-mg group, and significantly lower — 1.1% — in the 150-mg group. The rate of major bleeding was signi…