Dabigatran etexilate: a direct thrombin inhibitor

BACKGROUND Direct Thrombin Inhibitors (DTIs) represent a new and promising class of anticoagulants. Unlike heparin, they directly interact with thrombin and block fibrinogen binding. Dabigatran etexilate is becoming the most representative of the DTIs administered orally. AIM OF THE REVIEW This review aims at analysing efficacy and safety of the dabigatran in the prevention of venous and arterial thromboembolism. It analyses the pharmacokinetic and pharmacodynamic profile of dabigatran by underlying both advantages and disadvantages as compared to heparin and warfarin. It further analyses both phase 2 and phase 3 studies already completed and published and others still in progress, in terms of efficacy and clinical safety when compared with low molecular weight heparin and warfarin. The drug has been employed in different clinical settings such as the prevention of venous thromboembolism in patients undergoing major orthopedic surgery, the treatment of acute thromboembolism, the prevention of arterial thromboembolism (stroke and systemic embolism) in patients with chronic atrial fibrillation. CONCLUSIONS The results from clinical trials have shown an efficacy comparable to that of low molecular weight heparin and warfarin. Some doubts are still remaining about clinical safety, especially as concerning liver toxicity in long-term treatments.