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New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE-LY® Trial
Date:4/18/2012

RIDGEFIELD, Conn., April 18, 2012 /PRNewswire/ -- A new retrospective sub-analysis of the 18,113 patient RE-LY® trial showed lower rates of intracranial hemorrhage (ICH), including both fatal and traumatic ICH, for Pradaxa® (dabigatran etexilate mesylate) capsules 150mg taken twice daily compared with warfarin. Results of the sub-analysis recently were published online in Stroke: The Journal of the American Heart Association.

Intracranial hemorrhage can be a devastating complication of anticoagulation, particularly in older patients with atrial fibrillation. In the RE-LY trial, ICH consisted of intracerebral hemorrhage, subdural hematoma and subarachnoid hemorrhage. Intracranial hemorrhage is responsible for the majority of disability and death from treatment-related bleeding.

As previously reported in the pivotal RE-LY trial, the rate of ICH was 59 percent lower with PRADAXA 150mg (n=38) compared with warfarin (n=90). In this new RE-LY sub-analysis, 153 patients experienced 154 ICHs. The sub-analysis showed fewer fatal (13 vs. 32) and traumatic (11 vs. 24) ICH events in patients treated with PRADAXA 150mg compared to warfarin.

"These data further our understanding of the risk profile of PRADAXA compared to warfarin, showing a lower rate of both fatal and traumatic ICH with PRADAXA 150mg in patients with non-valvular atrial fibrillation, including those who were older," said Paul A. Reilly, Ph.D., clinical program director, Boehringer Ingelheim Pharmaceuticals, Inc. and an author of the sub-analysis.

The sub-analysis showed that in RE-LY, patients who experienced an ICH were, on average, older (mean age 75 [with ICH] vs. 71.5 [without ICH]) with a history of stroke or transient ischemic attack (TIA), used aspirin concomitantly, experienced less heart failure and had lower estimated creatinine clearance levels compared with study participants who did not experience an ICH. These differences were consisten
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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