F03 Dabigatran etexilate: advances in anticoagulation therapy

Evaluation of: Schulman S, Kearon C, Kakkar AK et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N. Engl. J. Med. 361, 2342-2352 (2009). Venous thromboembolism (VTE) is associated with significant morbidity and mortality. The need for anticoagulation therapy is well recognized, but treatment is frequently suboptimal owing to limitations of current agents. The RE-COVER (TM) trial compared 150 mg twice-daily dabigatran etexilate (herafter referred to as dabigatran) with warfarin for 6 months in patients with acute VTE; dabigatran was as effective as warfarin in preventing recurrent VTE, with comparable major bleeding and significantly lower total bleeding rates. The Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY (R)) trial on stroke prevention in patients with atrial fibrillation has also been completed recently, and dabigatran at higher doses showed superior efficacy in preventing stroke and systemic embolism, with lower bleeding than warfarin. Dabigatran provides convenient fixed-dose treatment without the need for monitoring, and has the potential to change the management of venous and arterial thromboembolism.