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The challenges of using warfarin to prevent stroke in patients with atrial fibrillation have sparked efforts to find better alternatives. Dabigatran etexilate — a drug that is not yet FDA-approved — is metabolized to a direct, competitive thrombin inhibitor that does not require anticoagulation monitoring. In this manufacturer-funded trial, investigators compared dabigatran (110 mg or 150 mg twice daily) with warfarin in 18,113 patients (mean age, 71) with AF who were at high risk for stroke, primarily to determine whether dabigatran is inferior to warfarin.
Median follow-up duration was 2 years, and study-drug discontinuation rates at 2 years were 21% in patients assigned to receive either dose of dabigatran and 17% in those assigned to war…