Boehringer Ingelheim has completed enrolment of the landmark RE-LY trial to evaluate the long-term efficacy and safety of their novel, oral direct thrombin inhibitor dabigatran etexilate (Pradaxa) for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF).
The RE-LY (Randomised Evaluation of Long Term Anticoagulant Therapy) trial is comparing two blinded doses of oral dabigatran etexilate with the current standard therapy, warfarin (target INR 2.0-3.0) in patients with non-valvular atrial fibrillation who are at moderate to high risk of stroke. Currently, the best available treatment to prevent stroke in these patients is the vitamin K antagonist, warfarin. Although the efficacy of warfarin is well established, its use is often limited due to its inherent drawbacks. Warfarin is associated with an unpredictable dose response and requires careful individual dosing and costly anticoagulation monitoring. It has a slow onset and offset of action and its metabolism is affected by diet, common drugs and genetic polymorphisms. It is estimated that warfarin is currently prescribed for only half of all eligible patients.
RE-LY is the largest stroke prevention in AF trial conducted to date, with 18,114 patients, in 1,000 centres in 44 countries worldwide enrolled between December 2005 and December 2007. Currently, over 10,000 patients have been treated for at least 6 months with final study results expected to be reported in early 2009.
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