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New Sub-Analysis of RE-LY Trial Examines Pradaxa in Patients with Atrial Fibrillation Undergoing Cardioversion
Date:1/5/2011

and bleeding similar to warfarin."

In the RE-LY trial, an imaging technique known as transesophageal echocardiography (TEE) was encouraged prior to cardioversion to identify existing clots in the left atrium of the heart, which would suggest an increased risk of stroke or embolism associated with cardioversion.(1)  TEE was performed prior to cardioversion in more patients on dabigatran 110mg and PRADAXA 150mg than warfarin (25.5%, 24.1%, 13.3%, respectively).(1)  Rates of stroke and systemic embolism were similar across all treatment arms for those who underwent TEE-guided cardioversions (0.61%, 0.00% and 1.14%, respectively; dabigatran 110mg vs. warfarin, p=0.65; PRADAXA 150mg vs. warfarin, p=0.17) and those who did not undergo TEE (0.83%, 0.39% and 0.52%, respectively; dabigatran 110mg vs. warfarin, p=0.54; PRADAXA 150mg vs. warfarin, p=0.75).(1)

"Physicians have expressed excitement about the recent approval of PRADAXA to reduce the risk of stroke for patients with atrial fibrillation," said Paul Reilly, PhD, clinical program director, Boehringer Ingelheim Pharmaceuticals, Inc.  "Boehringer Ingelheim remains committed to publishing data analyses from the RE-LY trial to help inform physicians about the clinical implications for patients taking PRADAXA."  

PRADAXA is the first oral anticoagulant to be approved in the U.S. in more than 50 years.  PRADAXA is now available in more than 35,000 pharmacies nationwide.  PRADAXA 75mg is also available for patients who have severe renal impairment.

About RE-LY®

RE-LY® was a global, Phase III, randomized trial of 18,113 patients(2) enrolled in 951 centers in 44 countries,(3) investigating whether PRADAXA (two blinded doses) was as effective as well-controlled warfarin – INR 2.0 - 3.0 – (open label) for stroke prevention.(2) Patients with NVAF and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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