Advances in oral anticoagulants: focus on dabigatran etexilate

Vitamin K antagonists, predominantly warfarin, have been the cornerstone of anticoagulation therapy for many decades. However, warfarin use is associated with limitations such as a slow onset of action, a narrow therapeutic index, numerous drug interactions, and frequent monitoring is required of prothrombin time and the international normalized ratio. These shortcomings prompted the development of new oral anticoagulants. Dabigatran etexilate is a novel, oral, reversible, direct thrombin inhibitor that acts on the terminal steps of the coagulation cascade overcoming many of warfarin's limitations. Currently, dabigatran etexilate is approved in multiple regions including Europe and Canada, for the primary prevention of venous thromboembolism in adults who have undergone total hip replacement or total knee replacement surgery. A Phase III trial demonstrated noninferiority of dabigatran etexlitate compared with warfarin for the prevention of stroke in patients with atrial fibrillation, and one Phase III trial showed superiority. There are several ongoing trials investigating the acute treatment of venous thromboembolism.