Dabigatran etexilate prevents recurrent VTE with less bleeding than warfarin

Dec 7 2009

Boehringer Ingelheim today announced very positive results from their landmark RE-COVER™ study – the most advanced trial programme assessing a novel oral anticoagulant in development for acute venous thromboemolism (VTE) treatment – presented at the American Society of Hematology Annual Meeting and published in the New England Journal of Medicine online.

The oral direct thrombin inhibitor, dabigatran etexilate (150 mg twice-daily, BID), showed equal efficacy compared to well-controlled warfarin at preventing recurrent VTE (2.4% vs. 2.1%, hazard ratio 1.10, 95% CI 0.65 to 1.84, p<0.001 for prespecified non-inferiority margin). For safety, dabigatran etexilate demonstrated a significant 37% reduction in major or clinically relevant non-major bleeding>

“The results of RE-COVER™ are a long-awaited breakthrough in the treatment of VTE; not only does dabigatran etexilate offer an effective therapy to prevent recurrent VTE it does so with less bleeding than warfarin.” commented Dr Sam Schulman, Principal Investigator, Department of Medicine, McMaster University, Hamilton, Canada. “Warfarin is a highly effective therapy when well-controlled within its narrow therapeutic range, as in clinical trials, but in the real world sufficient control is rarely achieved and maintained, leaving patients poorly protected from VTE or at risk of bleeding. With dabigatran, we have a therapy that protects our patients effectively and safely, without need for frequent laboratory monitoring and dose changes.”