Dabigatran etexilate: a review of its use in the treatment of acute venous thromboembolism and prevention of venous thromboembolism recurrence.

Dabigatran etexilate (Pradaxa(®), Prazaxa(®)) has recently been approved for the treatment of acute venous thromboembolism (VTE) and prevention of VTE recurrence. Dabigatran etexilate is an oral prodrug of dabigatran, a selective, reversible, competitive, direct thrombin inhibitor. Dabigatran etexilate has a wide therapeutic range that allows for fixed-dose administration without the need for routine monitoring, a requirement of standard vitamin K antagonist (VKA) therapy. In randomized phase III trials in patients with acute VTE (RE-COVER and RE-COVER II), long-term treatment with oral dabigatran etexilate 150 mg twice daily for 6 months after initial parenteral anticoagulation was noninferior to dose-adjusted warfarin with regard to the incidence of recurrent symptomatic VTE or related death. In randomized trials of patients with previously treated VTE, extended dabigatran etexilate treatment was noninferior to warfarin (RE-MEDY) and significantly more effective than placebo (RE-SONATE) with regard to the incidence of recurrent VTE or related death. Dabigatran etexilate was generally well tolerated, with a similar incidence of major bleeding to that with warfarin in individual studies (although pooled data showed a significantly lower incidence in patients with acute VTE), and significantly lower incidences of the combined endpoint of major or clinically relevant nonmajor bleeding and of any bleeding than with warfarin. However, in the RE-SONATE trial, dabigatran etexilate was associated with a higher risk of bleeding than placebo. In conclusion, dabigatran etexilate is a valuable treatment option for acute VTE and prevention of VTE recurrence, providing an effective and convenient alternative to standard VKA therapy with the potential for a lower overall rate of bleeding.

RCT Entities:   Population Interventions Outcomes