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.