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Boehringer Ingelheim Announces Enrollment is Complete for the Largest Atrial Fibrillation Outcomes Trial - The RE-LY(TM) Study
Date:1/17/2008

RIDGEFIELD, Conn., Jan. 17 /PRNewswire/ -- Boehringer Ingelheim announced today that enrollment is complete for the landmark RE-LY trial to evaluate the long-term efficacy and safety of investigational oral direct thrombin inhibitor dabigatran etexilate for the prevention of stroke and systemic embolism in patients with atrial fibrillation. RE-LY (Randomized Evaluation of Long Term Anticoagulant Therapy) is the largest stroke prevention in atrial fibrillation trial conducted to date, with 18,114 patients, in 1,000 centers in 44 countries worldwide enrolled between December 2005 and December 2007. Currently, more than 10,000 patients have been treated for at least 6 months with final study results expected to be reported in early 2009.

The RE-LY trial is comparing two blinded doses of oral dabigatran etexilate with warfarin sodium (target INR 2.0-3.0) in patients with non-valvular atrial fibrillation who are at moderate-to-high risk of stroke. Currently, the standard treatment to prevent stroke in these patients is the vitamin K antagonist, warfarin. It is estimated that warfarin is currently prescribed for only half of all eligible patients.

Dr. Salim Yusuf, Professor of Epidemiology and Cardiology and head of the study coordinating center at McMaster University in Hamilton, Canada, stated that: "Patient enrollment in RE-LY has exceeded our original expectations by far."

Atrial fibrillation is the most common sustained cardiac rhythm disturbance affecting six percent of individuals over the age of 65 and 10 percent of people over the age of 80. Atrial fibrillation is a leading risk factor for stroke and, despite warfarin sodium being available as an effective treatment option, atrial fibrillation still accounts for approximately 15 percent of all strokes.

Approximately 750,000 Americans suffer a stroke each year. More than 150,000 of these strokes are fatal, making it the third leading cause of death in the United States. Approxima
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SOURCE Boehringer Ingelheim
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