Drug review – Dabigatran for stroke prevention in atrial fibrillation
Janet Marianne Jackson PhD
JUST Medical Media Limited, Auckland, New Zealand
The incidence of atrial fibrillation (AF) is growing at an increasing rate and presents major health problems due to its high association with stroke and systemic embolism. Antithrombotic therapy is highly effective for stroke prevention in AF using the vitamin K antagonist warfarin. However, this approach does not provide adequate therapy for all eligible patients due to the limitations and complications of using warfarin. Underuse of oral anticoagulant therapy has prompted the search for a safe and effective alternative to warfarin that does not require regular monitoring, and with improved safety and tolerability. New anticoagulants, such as dabigatran, a direct thrombin inhibitor, target specific steps in the coagulation cascade. Dabigatran demonstrates stable and predictable pharmacology with rapid dose-related anticoagulant activity following oral administration and conversion from its prodrug dabigatran etexilate. Dabigatran has been found to be an effective anticoagulant for the prevention of thomboembolic events following surgery for hip or knee replacement compared with subcutaneous enoxaparin, a low-molecular-weight heparin.
Clinical data from Phase II and Phase III trials indicate that there are two therapeutic doses of dabigatran that are at least as effective as warfarin in stroke prevention in patients with AF and with similar or improved bleeding rates. Dabigatran provides convenient fixed-dose treatment without the need for monitoring, and has the potential to improve the management of venous and arterial thromboembolism. Dabigatran may provide an alternative and more cost-effective therapy to warfarin for stroke prevention in patients with AF.