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Data From Largest Stroke Prevention Trial in Atrial Fibrillation To Premiere at European Society of Cardiology Congress
Date:8/25/2009

RIDGEFIELD, Conn., Aug. 25 /PRNewswire/ -- Results of the Phase III RE-LY(R) (Randomized Evaluation of Long-Term Anticoagulant Therapy, Warfarin, Compared to Dabigatran)(1) study will be presented at the European Society of Cardiology (ESC) Congress in Barcelona on Sunday, Aug. 30. The primary objective of RE-LY was to assess the safety and efficacy of the investigational oral direct thrombin inhibitor, dabigatran etexilate, against the current standard therapy, warfarin, for the prevention of stroke in patients with atrial fibrillation (AF).(1)

Atrial fibrillation affects approximately 2.3 million Americans(2) and can increase the risk of stroke five-fold.(3) Top-line findings from the 18,113 patient RE-LY study(1) will be featured in an ESC press briefing on Sunday, Aug. 30 at 8:00 a.m. CEST, with the full results presented in a "Hot-Line" session at 11:00 a.m. CEST. The study will also be simultaneously published in a leading peer-reviewed medical journal.

Dabigatran etexilate is an investigational oral anticoagulant in Phase III development for stroke prevention in AF(1) and several other therapeutic areas, including prevention of atherothrombotic events in patients with acute coronary syndrome,(4) as well as primary prevention, (5),(6),(7) secondary prevention(8) and treatment of venous thromboembolism.(9) Dabigatran etexilate is not yet approved by the U.S. Food and Drug Administration.

In addition to the primary findings, a RE-LY sub-analysis of treatment naive patients will also be presented during a "Clinical Trial Update" session on Wednesday, Sept. 2 at 8:00 a.m. CEST.

About RE-LY: The largest AF outcomes trial to date

RE-LY was a global, Phase III, randomized trial of 18,113 patients(1) enrolled in more than 900 centers in 44 countries,(1) investigating whether dabigatran etexilate (two blinded doses) was as effective as well-con
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SOURCE Boehringer Ingelheim Pharmaceuticals
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