Results of two pre-specified sub-study analyses of the 18,113 patient RE-LY® trial, involving the newly approved oral anticoagulant Pradaxa® (dabigatran etexilate mesylate) capsules, will be presented at the American Heart Association's Annual Scientific Sessions on Monday, November 15, 2010. The analyses assessed the prognostic value of two separate biomarkers (D-dimer and NT-proBNP) for predicting cardiovascular events in patients with non-valvular atrial fibrillation (AFib).
RE-LY® was a global, Phase III, randomized trial, which investigated whether PRADAXA was as effective as well-controlled warfarin (open label) for stroke prevention in patients with non-valvular atrial fibrillation.The study provided the basis for the U.S. Food and Drug Administration's (FDA) recent approval of PRADAXA to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Well-controlled warfarin, defined as INR 2.0 – 3.0, has been shown to reduce the risk of stroke in patients with non-valvular atrial fibrillation. Results of the RE-LY® trial demonstrated PRADAXA 150mg taken twice daily significantly reduced stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin. PRADAXA 150mg taken twice daily also significantly reduced both ischemic and hemorrhagic strokes compared to warfarin.
PRADAXA is the only approved oral anticoagulant that has been shown to significantly reduce the risk of stroke compared to warfarin and is the first oral anticoagulant to be approved in the U.S. in more than 50 years. PRADAXA is now available in more than 35,000 pharmacies nationwide.
Boehringer Ingelheim Pharmaceuticals, Inc.