Dabigatran etexilate belongs to a new group of anticoagulants - oral direct thrombin inhibitors. It has favourable pharmacological properties which enable uniform dosage without a need for monitoring of the anticoagulant effect.
The efficacy and safety of dabigatran have been established in a number of clinical trials focused on the prevention and treatment of venous thromboembolism. RE-LY, a recently published trial in patients with atrial fibrillation, demonstrated a reduced risk of stroke and systemic embolism with dabigatran treatment compared to warfarin as well as a low risk of bleeding and a significant reduction in haemorrhagic stroke.
Dabigatran has been approved for the prophylaxis of venous thromboembolism in hip and knee replacement surgery. Based on the results of the RE-LY trial, the indications for dabigatran are expected to extend and include the prevention of thromboembolic complications in a wide range of patients with atrial fibrillation.
So far, much less information is available on the appropriateness of dabigatran use in patients with acute coronary syndromes or in those with artificial heart valves.