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New Subanalyses of RE-LY® Trial Evaluate PRADAXA in Subsets of Patients with Non-Valvular Atrial Fibrillation
Date:11/14/2011

RIDGEFIELD, Conn., Nov. 14, 2011 /PRNewswire/ -- A new retrospective subanalysis of the RE-LY® trial found Pradaxa® (dabigatran etexilate mesylate) capsules 150mg twice daily reduced the risk of stroke and systemic embolism compared to warfarin in patients with non-valvular atrial fibrillation (NVAF) irrespective of the presence of symptomatic heart failure (sHF), with no significant interaction for major bleeding events.(1) The results were presented today at the American Heart Association's Scientific Sessions 2011.

Heart failure is a serious condition that occurs when the heart is unable to pump enough blood to meet the body's needs.(2) Up to 30 percent of heart failure patients have atrial fibrillation (AFib),(3) and heart failure can increase the risk of stroke for patients with AFib.(4) Heart failure also can increase the risk of bleeding in anticoagulated patients.(5)

"Since heart failure and AFib frequently coexist, this subanalysis is particularly important to physicians who treat patients with non-valvular atrial fibrillation," said Paul Reilly, PhD, clinical program director, Boehringer Ingelheim Pharmaceuticals, Inc.  "These findings add to the growing body of data about the use of PRADAXA in this patient population."

The subanalysis assessed the effects of PRADAXA 150mg twice daily compared to warfarin in a prespecified subset of patients with previous sHF (n = 4,904).(1) The analysis found that while annual event rates of stroke or systemic embolism were higher overall for patients with sHF at baseline (PRADAXA 150mg: 1.44%; warfarin: 1.92%) than those without sHF (PRADAXA 150mg: 1.00%; warfarin: 1.64%), PRADAXA 150mg twice daily reduced the risk of stroke compared to warfarin for both groups of patients (HR = 0.75 for patients with sHF; HR = 0.61 for patients without sHF; p-value for interaction = 0.39).(1)

Annual event rates for major bleeding were lower with PRADAXA 150mg twice daily than warfar
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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