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Spironolactone Utilization among Patients with Reduced and Preserved Ejection Fraction Heart Failure

    Basic Details

    Spironolactone is a mineralocorticoid receptor antagonist indicated for the management of heart failure with reduced ejection fraction (HFrEF). In a previous clinical trial, spironolactone significantly lowered the incidence of heart failure (HF) hospitalizations among HF patients with preserved ejection fraction (HFpEF). Real world utilization of spironolactone in HFrEF and HFpEF is unknown. 

    We conducted a retrospective cohort study using data from FDA’s Sentinel System. We identified patients with HFrEF or HFpEF using diagnosis and procedure codes from a previously validated algorithm. We required patients to be continuously enrolled in the 183 days prior to HF diagnosis. Follow-up started on the day of HF diagnosis and ended at the earliest occurrence of a spironolactone dispensing, disenrollment, death, or end of data. We calculated the proportion of spironolactone utilization, and for those initiating treatment, we estimated the dose and duration of the first continuous treatment episode.


    Efe Eworuke, Austin Cosgrove, Qoua Liang Her, Jennifer G. Lyons, Dave Martin, Sruthi Adimadhyam

    Corresponding Author

    Efe Eworuke; Division of Epidemiology, US Food and Drug Administration, Silver Spring, MD.