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New Subanalyses of the RE-LY Trial Showed Pradaxa Reduced Stroke Risk in Patients With Varying CHA2DS2-VASc Scores and Types of Non-Valvular Atrial Fibrillation
Date:4/4/2011

RIDGEFIELD, Conn., April 4, 2011 /PRNewswire/ -- Two new retrospective subanalyses of the RE-LY® trial, involving Pradaxa® (dabigatran etexilate mesylate) capsules, suggested that the reduction in stroke risk achieved with PRADAXA 150mg over warfarin (1) occurred irrespective of CHA2DS2-VASc risk score (2) and the type of non-valvular atrial fibrillation (NVAF) (permanent, persistent and paroxysmal)(3).  The results were presented at the American College of Cardiology's 60th Annual Scientific Session. (2,3)  

The first subanalysis assessed the impact of the novel CHA2DS2-VASc risk score,(2) which determines stroke risk based on age, sex and the presence of comorbidities,(4) on outcomes in the RE-LY trial.  Patients were grouped into quartiles based on CHA2DS2-VASc score (0-2, 3, 4, 5-9) (2) and results showed that PRADAXA 150mg was associated with reductions in stroke risk compared to warfarin for all four quartiles (0-2, RR = 0.63; 3, RR = 0.61; 4, RR = 0.53; 5-9, RR = 0.77; interaction p-value = 0.60).(2) Results of the analysis showed there was a significant interaction between CHA2DS2-VASc score and rates of major bleeding, with lower rates for PRADAXA 150mg compared to warfarin for patients in the first three quartiles, but an increased rate of major bleeding for the quartile at greatest risk (0-2, RR = 0.75; 3, RR = 0.74; 4, RR = 0.83; 5-9, RR = 1.33; interaction p-value = 0.003).(2)

"This analysis suggests that PRADAXA 150mg taken twice daily may reduce the risk of stroke compared to warfarin across the levels of NVAF-associated stroke risk, as determined by the CHA2DS2-VASc score," said Paul Reilly, Ph.D., clinical program director, Boehringer Ingelheim Pharmaceuticals, Inc.  "These findings are important because the risk of stroke in patients with NVAF increases significantly with the presence of comorbidities, such as diabetes or hypertension."

PRADAXA was also evaluated in a second RE-LY suban
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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