However, one study suggests that prothrombin complex concentrates may be ineffective for reversing the effects of dabigatran. Prior to the approval of a reversal agent, the therapy for major bleeding while on dabigatran consisted of discontinuation of the agent, local bleeding control measures, blood transfusions, activated charcoal (in cases of recent ingestion), and hemostatic therapy (plasma, vitamin K, factor concentrates, cryoprecipitate, platelets). This lack of an effective reversal agent has remained a challenge to these agents’ widespread utilization. 2 A major concern with newer oral agents, including dabigatran, was a lack of a specific reversal agent to be administered in case of severe and life-threatening bleeding.
Dabigatran, at a dose of 150 mg twice daily, has demonstrated better efficacy in stroke prevention in AF with similar rates of major bleeding compared with warfarin in the RE-LY trial. 1 Unlike the vitamin K receptor antagonist warfarin, dabigatran therapy has a quicker onset and offset of action, does not require routine monitoring of coagulation parameters, and presents less potential for drug–drug and drug–diet interactions. Dabigatran (Pradaxa, Boehringer Ingelheim) is the first oral direct thrombin inhibitor approved by the Food and Drug Administration (FDA) for stroke prevention in atrial fibrillation (AF) and the treatment of venous thromboembolism (VTE).
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