New Sub-Analysis Evaluates Outcomes Associated with Lower Intracranial Hemorrhage Rates for Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in the RE... (t across treatment arms. A history of fa...)

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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

t across treatment arms. A history of falling was not an independent risk factor for ICH among RE-LY participants.

"Understanding the risk of ICH is a critical factor when prescribing anticoagulation therapy," said John Smith, M.D., Ph.D., senior vice president for clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The sub-analysis highlights important information for physicians on independent predictors of ICH, including age, prior history of stroke or TIA and aspirin use."

In RE-LY, PRADAXA 150mg taken twice daily significantly reduced stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin dosed to target INR 2.0 to 3.0 (median TTR 67%). PRADAXA 150mg also was shown to significantly reduce both ischemic and hemorrhagic stroke compared to warfarin in patients with non-valvular atrial fibrillation (NVAF). Effects of PRADAXA compared to warfarin were more apparent in patients with lower levels of INR control.

Additional Sub-Analysis Results

The rate of ICH at all sites (intracerebral, subdural and subarachnoid) was lower for PRADAXA 150mg versus warfarin (includes both spontaneous and traumatic ICH):

The rate of intracerebral hemorrhage was lower with PRADAXA 150mg (0.09%/year, n=11) compared with warfarin (0.39%/year, n=46; RR=0.23; 95% CI, 0.12–0.45)
The rate of subdural hematoma was lower with PRADAXA 150mg (0.20%/year, n=24) compared with warfarin (0.31%/year, n=36; RR=0.65; 95% CI, 0.39–1.1)
The rate of subarachnoid hemorrhage was lower with PRADAXA 150mg (0.02%/year, n=2) compared with warfarin (0.06%/year, n=8; RR=0.24; 95% CI, 0.05–1.2)

For patients who experienced a spontaneous or traumatic ICH, mortality outcomes were similar between PRADAXA 150mg (35 percent) and warfarin (36 percent) across sites (intracerebral, subdural and subarachnoid).

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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