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

    Basic Details

    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.


    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