Friday February 12, 2010
About Dabigatran

Dabigatran is an anticoagulant from the class of the direct thrombin inhibitors. It is being studied for various clinical indications and may replace warfarin as the preferred anticoagulant in many cases. Unlike warfarin it works right away and does not require INR monitoring.

Phase 3 clinical trials are ongoing in treatment and prevention of secondary venous thromboembolism (VTE) in post-operative orthopedic patients; long-term prophylaxis in acute coronary syndrome and stroke patients with atrial fibrillation and symptomatic VTE because of various causes. Dabigatran at doses of 150 mg and 220 mg once daily when compared with the standard 40 mg dose of enoxaparin once daily, confirmed that dabigatran performed as well as enoxaparin in preventing thrombosis, with a similar risk profile.

Absorption is unrelated to food but may be decreased if taken with a proton pump inhibitor. Metabolism is slowed in people taking quinidine, verapamil, or amiodarone.

Approval from FDA is expected in 2010.