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Gastrointestinal bleeding with dabigatran, a comparative study with warfarin: a multicenter experience.

Muhammed Sherid, Humberto Sifuentes, Samian Sulaiman

    The Korean Journal of Gastroenterology = Taehan Sohwagi Hakhoe Chi
    |April 22, 2015
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    Summary

    Dabigatran showed a lower risk of gastrointestinal bleeding compared to warfarin. Key risk factors for dabigatran-related bleeding include the initial 100 days of treatment, older age, and prior bleeding history.

    Keywords:
    AntithrombinsDabigatranGastrointestinal hemorrhagePlatelet aggregation inhibitorsWarfarin

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    Area of Science:

    • Pharmacology and Therapeutics
    • Clinical Medicine
    • Gastroenterology

    Background:

    • The comparative risk of gastrointestinal (GI) bleeding between dabigatran and warfarin remains a subject of debate.
    • Previous studies have yielded controversial findings regarding this safety profile.

    Purpose of the Study:

    • To evaluate and compare the incidence of GI bleeding in patients treated with dabigatran versus warfarin.
    • To identify specific risk factors associated with GI bleeding in patients taking dabigatran.

    Main Methods:

    • A retrospective review of medical records for patients initiated on dabigatran or warfarin between October 2010 and October 2012.
    • Data were collected from two hospital settings, including 417 patients (208 on dabigatran, 209 on warfarin).

    Main Results:

    • Dabigatran was associated with a significantly lower rate of GI bleeding (4.8%) compared to warfarin (10.1%; p=0.0375).
    • For dabigatran users, the first 100 days of therapy (p=0.0007), age over 65 (p=0.0453), and a history of GI bleeding (p=0.036) were identified as significant risk factors.
    • The lower GI tract was the predominant site of bleeding in the dabigatran group (80.0%).

    Conclusions:

    • Dabigatran demonstrates a reduced risk of GI bleeding compared to warfarin.
    • Early treatment duration (≤100 days), advanced age (>65 years), and a prior GI bleeding history are critical risk factors for dabigatran-associated GI bleeding.