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Expert Opin Drug Saf. 2014 May;13(5):639-47. doi: 10.1517/14740338.2014.895321. Epub 2014 Mar 5.

Dabigatran etexilate for venous thromboembolism: a safety evaluation.

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  • 1University of Birmingham, CityHospital, Centre for Cardiovascular Sciences , Birmingham , UK.



Recently, 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).


We 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.


For 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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