Stroke Prevention Drug Offers Alternative to Warfarin

 

October 4, 2010

The RE-LY study established the safety and efficacy of Pradaxa (generic: dabigatran etexilate) for stroke prevention in patients with atrial fibrillation (AFib) without INR monitoring, dose adjustments or food restrictions. Dabigatran etexilate is an oral direct thrombin inhibitor. The U.S. Food and Drug Administration (FDA) approved Pradaxa for patients with atrial fibrillation in October 2010.

Previously, warfarin has been the only oral anticoagulant available in the United States for stroke prevention in patients with AFib. Current guidelines for patients with non-valvular AFib treated with warfarin recommend maintaining an INR control range of 2.0-3.0 through regular blood monitoring and dose adjustments.

RE-LY was a global Phase III trial investigating whether dabigatran etexilate was as effective as well-controlled warfarin for stroke prevention. Patients with non-valvular AFib and at least one other risk factor for stroke were enrolled in the study for two years with a minimum follow-up period of one year.

The trial utilized the established PROBE (prospective, randomized, open-label, blinded endpoint evaluation) protocol, which is more reflective of the differences in the management of warfarin and dabigatran in clinical practice.

Atrial fibrillation is the most common significant heart rhythm disorder and is associated with a nearly five-fold increased risk of stroke.

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