Pharmacy and Wellness Review


Serious clinical complications associated with venous thrombotic embolism (VTE) necessitate prophylaxis in patient groups who are at high risk of VTE, specifically those recovering from orthopedic surgery with atrial fibrillation, with mechanical heart valves, at increased risk for stroke, or recovering post-MI. Currently, prophylaxis with warfarin, enoxaparin, or fondaparinux has been the standard of therapy, but these therapies each have their limitations. Dabigatran etexilate is an orally available pro-drug of dabigatran, a competitive, reversible, direct inhibitor thrombin (Factor lla). The agent is converted by esterases, and, thus, not associated with the complications of the CYP enzyme system. Dabigatran follows a linear dose-response curve simplifying dosing compared to other agents. In the BISTRO II study, a dose as low as 50 mg dabigatran was found to be non-inferior to the current standard of therapy of 40 mg enoxaparin, and BISTRO I and II, RE-NOVATE and RE-LY all found dabigatran was better or equivalent to warfarin therapy for post-hip and knee replacements. Dabigatran could be especially beneficial in patients who have a contraindication to warfarin, need long-term anticoagulation and require less patient monitoring. With FDA approval and release of this drug, time will provide safety and efficacy data to solidify dabigatran's place in therapy along current anti-coagulation guidelines.



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