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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

60;In the analysis, the peri-operative phase was defined as seven days before until 30 days following the procedure.(8) The analysis found no significant difference in the risk of bleeding, including major (RR = 1.08; p = 0.64), minor (RR = 1.15; p = 0.25), fatal (RR = 1.01; p = 0.99), bleeding requiring re-operation (RR = 1.39; p = 0.32) and bleeding requiring red blood cell transfusion (RR = 0.85; p = 0.37), between patients receiving PRADAXA 150mg twice daily compared to warfarin.(8)  The analysis also found that patients in all treatment arms who had emergency surgery were at much higher risk of major bleeding than those undergoing elective surgery (PRADAXA 150mg: 17.4% vs. 3.8%; warfarin: 21.7% vs. 3.3%; p<0.001 for all); however, there was no significant difference between treatment arms for either type of surgery.(8) Additionally, in all treatment arms, major bleeding was more common for major compared to minor surgery (PRADAXA 150mg: 6.4% vs. 3.2%; warfarin: 8.0% vs. 1.8%; p<0.01 for all), with no significant difference between treatment arms.(8)

About RE-LY

RE-LY was a global, Phase III, randomized trial of 18,113 patients(6) enrolled in 951 centers in 44 countries,(9) investigating whether dabigatran etexilate (two blinded doses) was as effective as well-controlled warfarin – INR 2.0 - 3.0 – (open label) for stroke prevention.(6)  Patients with non-valvular AFib and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack, or systemic embolism, left ventricular dysfunction, age greater than or equal to 75 years, age greater than or equal to 65 years with either diabetes mellitus, history of coronary artery disease, or hypertension) were enrolled in the study for two years(6) with a minimum follow-up period of one year.(10)

The RE-LY trial utilized the established PROBE (prospective, randomized, open-label, blinded endpoint evaluation) clinical trial protoco
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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