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Final Patient Completes Treatment In Boehringer Ingelheim's RE-LY(R) Study, The Largest Atrial Fibrillation Outcomes Trial To Date
Date:3/20/2009

RIDGEFIELD, Conn., March 20 /PRNewswire/ -- Boehringer Ingelheim today announced that the last patient has completed treatment in the Phase III Randomized Evaluation of Long term Anticoagulant therapy (RE-LY(R)) study. This study compared the long-term efficacy and safety of the oral direct thrombin inhibitor dabigatran etexilate with the current standard therapy, warfarin (target international normalized ratio, INR, 2-3) for the prevention of stroke and non-CNS systemic embolism in patients with atrial fibrillation (AF). Dabigatran etexilate is an oral anticoagulant in Phase III development for stroke prevention in AF, as well as several other therapeutic areas. Dabigatran etexilate is not approved by the FDA. RE-LY(R) is the largest AF stroke prevention trial to date. The study enrolled 18,113 patients in more than 900 centers in 44 countries worldwide between December 2005 and December 2007. Data will now be analyzed and results are expected to be presented later this year at the European Society of Cardiology (ESC) Congress, taking place in Barcelona, Spain, from August 29th until September 2nd.

"We are delighted with the completion of treatment in the RE-LY study as it marks an important milestone in the ongoing development of dabigatran etexilate," said Paul Reilly, clinical program director, Boehringer Ingelheim. "We are grateful to the patients and investigators who participated in the study and look forward to further evaluating the safety and efficacy of dabigatran through the analysis of the data."

Atrial fibrillation affects more than 2.2 million Americans, making it the most common heart rhythm disorder in the U.S.(1) People with AF are at increased risk for forming blood clots in their hearts(2) which can raise their risk of stroke five-fold.(3) However, clinical studies show that up to 60 percent of AF related strokes can be prevented with appropriate anticoagulant therapy.(4) Vitamin K antagonists are the c
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