Boehringer Ingelheim completes treatment in Phase III atrial fibrillation trial

Boehringer Ingelheim has reported that the last patient has completed treatment in the Phase III randomized evaluation of long term anticoagulant therapy study.

This randomized evaluation of long term anticoagulant therapy (RE-LY) study compared the long-term efficacy and safety of the oral direct thrombin inhibitor dabigatran etexilate with the current standard therapy, warfarin, 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 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 announced later in 2009, the company said.

Paul Reilly, clinical program director of Boehringer Ingelheim, said: 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. 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.