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

Results published in Stroke showed lower absolute ICH mortality rates for PRADAXA compared to warfarin

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. Read more