For more than 5 decades,
warfarin has been the mainstay of
therapy when oral anticoagulation is required. It has been shown to be effective in the prevention as well as treatment of various thromboembolic disorders. However, drawbacks of
warfarin, such as time-consuming requirements for frequent international normalized ratio monitoring, as well as
drug and food interactions, have encouraged the development of alternative oral agents. One such agent,
dabigatran, has risen up to the challenge. Due to its predictable anticoagulation response,
dabigatran does not require routine anticoagulation monitoring. Another advantage
dabigatran has over
warfarin is its more favorable
drug and food interaction profiles.
Dabigatran was shown to be noninferior to
warfarin in studies evaluating the prevention of
stroke and systemic
embolism in patients with
atrial fibrillation, thus leading to the US Food and Drug Administration approval for this indication.
Dabigatran has also demonstrated efficacy in the prevention of
venous thromboembolism in patients undergoing total hip or knee replacement surgery as well as the prevention of recurrent
venous thromboembolism, although these are not current Food and Drug Administration-approved indications. The safety profile appears to be similar to
warfarin with regards to overall
bleeding risk, though the risk for gastrointestinal bleeds was higher in patients on
dabigatran 150 mg twice daily. Disadvantages of
dabigatran may include a higher frequency of
dyspepsia compared with
warfarin, lack of dosing information in severe renal impairment, possible missed opportunities for periodic health examinations and interventions due to elimination of regular physician's visit for international normalized ratio monitoring, and drug costs. This article provides an overview of the clinical studies, pharmacokinetic profile, adverse effects, drug interactions as well as advantages and disadvantages associated with
dabigatran.