• Expert Opin Drug Saf · May 2014

    Review

    Dabigatran etexilate for venous thromboembolism: a safety evaluation.

    • Richard Brown, Gregory Yh Lip, and Pilar Gallego.
    • University of Birmingham, CityHospital, Centre for Cardiovascular Sciences , Birmingham , UK.
    • Expert Opin Drug Saf. 2014 May 1;13(5):639-47.

    IntroductionRecently, new oral anticoagulants (NOACs) have become available to treat thromboembolic disorders. The efficacy and safety of these agents have been thoroughly tested in various clinical trials. In this article, we discuss the evidence for the safety and efficacy of dabigatran in the prevention and treatment of venous thromboembolism (VTE).Areas CoveredWe discuss the pharmacology of dabigatran and compare it to that of warfarin and two of the other popular NOACs, rivaroxaban and apixaban. The indications for and evidence behind dabigatran in the prevention of VTE are presented, as well as the trials examining its potential use for the treatment and extended treatment of VTE. We conclude by considering the safety aspects of the drug.Expert OpinionFor most patients the overall net clinical benefit would seem to be in favour of dabigatran. Both efficacy and safety have been proven in the setting of robust randomised controlled trials. 'Real world' registry data as well as long-term trial follow-up will add further critical information. Long-term experience might be one of the few advantages warfarin still has over dabigatran in patients who are eligible for both.

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