RIDGEFIELD, Conn., Nov. 11, 2010 /PRNewswire/ — Results
of two pre-specified sub-study analyses of the 18,113 patient
RE-LY® trial,(1) involving the newly approved oral
anticoagulant Pradaxa® (dabigatran etexilate mesylate)
capsules,(2) 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).(3,4)
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.(1) 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.(2)
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.(5) 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.(2) PRADAXA 150mg taken
twice daily also significantly reduced both ischemic and
hemorrhagic strokes compared to warfarin.(2)
PRADAXA is the only approved oral anticoagulant that has been
shown to significantly reduce the risk of stroke compared to
warfarin(2) 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.
About RE-LY®
RE-LY® was a global, Phase III, randomized trial(1) of
18,113 patients(1) enrolled in 951 centers in 44 countries,(6)
investigating whether PRADAXA (two b
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