Risk of Stroke and Bleeding in Atrial Fibrillation Treated with Apixaban Compared with Warfarin

    Basic Details
    Date
    Monday, September 28, 2020
    Type
    Publication
    Description

    A previous FDA study reported a favorable benefit risk for apixaban compared with warfarin for stroke prevention in older non-valvular atrial fibrillation (NVAF) patients (≥ 65 years). However, it remains unclear whether this favorable benefit risk persists in other populations including younger users. We examined if a similar benefit risk was observed in the Sentinel System and if it varied by age group.

    Author(s)

    Marie Bradley, Emily C. Welch, Efe Eworuke, David J. Graham, Rongmei Zhang, Ting-Ying Huang

    Corresponding Author

    Marie Bradley; Division of Epidemiology II, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
    Email: marie.bradley@fda.hhs.gov