Dabigatran etexilate for the prevention of stroke in patients with nonvalvular atrial fibrillation

SUMMARY For patients with nonvalvular atrial fibrillation, dabigatran etexilate is a new oral direct thrombin inhibitor to prevent stroke and systemic embolization. Dabigatran has few drug or food interactions, and has predictable pharmacokinetics that obviate the need for routine monitoring. The efficacy of dabigatran was established in the RELY trial, which found that dabigatran 150 mg twice-daily was superior to dose-adjusted warfarin for the prevention of stroke in patients with nonvalvular atrial fibrillation, but with similar rates of bleeding. Dabigatran dosed at 110 mg twice-daily was noninferior to warfarin for the prevention of stroke, but had a lower risk of bleeding. There are few commercially available assays to monitor the effects of dabigatran and there is no known antidote that can complicate the management of emergent bleeding. For selected patients, dabigatran provides a net clinical benefit over warfarin, both in terms of morbidity, cost and patient satisfaction.