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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

in in patients with sHF at baseline (PRADAXA 150mg: 3.10%; warfarin: 3.90%) and those without sHF (PRADAXA 150mg: 3.39%; warfarin: 3.45%).(1) There was no significant interaction for major bleeding events between the two subgroups of patients (HR = 0.79 for patients with sHF; 0.99 for patients without sHF; p-value for interaction = 0.74).(1) Additionally, annual rates of intracranial bleeding were lower with PRADAXA 150mg twice daily than warfarin in patients with sHF at baseline (PRADAXA 150mg: 0.26%; warfarin: 0.65%) and those without sHF (PRADAXA 150mg: 0.34%; warfarin: 0.80%).(1) There was no significant interaction for intracranial bleeding events between the two subgroups of patients (HR = 0.39 for patients with sHF; 0.42 for patients without sHF; p-value for interaction = 0.72).(1)

"It is important that we continue to analyze the data from RE-LY to better understand the use of PRADAXA in different types of non-valvular atrial fibrillation patients," said John Smith, MD, PhD, senior vice president for clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Boehringer Ingelheim is committed to informing physicians about the clinical implications for patients taking PRADAXA through data analyses such as these."

PRADAXA was approved by the U.S. Food and Drug Administration in October 2010 to reduce the risk of stroke and systemic embolism in patients with NVAF.(6) PRADAXA has been shown to reduce both ischemic and hemorrhagic stroke compared to warfarin in patients with NVAF.(6)  In the first eleven months after approval, more than 420,000 patients in the U.S. were prescribed PRADAXA.(7) Dabigatran is recommended in a 2011 update to atrial fibrillation treatment guidelines.

Additional RE-LY Subanalysis Presented at AHA

A second subanalysis assessed the risk of peri-operative bleeding with PRADAXA 150mg twice daily compared to warfarin in patients undergoing surgery (n = 4,615).(8) 
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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