Sex-differences in reporting of statin-associated diabetes mellitus to the US Food and Drug Administration

Abstract

ABSTRACTObjectiveDetermine whether statin-associated DM is reported more frequently in women than men in post-marketing adverse drug event (ADE) surveillance.DesignRetrospective pharmacovigilance analysisData sourcePublicly available FDA Adverse Event Reporting System (FAERS) from January 1997 through December 2023.SettingReal-world spontaneously reported ADEs in the United States.ParticipantsCommunity patients reporting statin ADEs during the study period.Interventions/exposuresAdverse drug event reports that included at least one statin.Main outcome measuresProportional reporting ratio to identify increased rates of statin-associated DM events in women and men compared with all other medications, and reporting odds ratio to compare reporting rates in women vs. men.ResultsA total of 18,294,814 ADEs were reported during the study period. Among statin-associated ADEs, 14,897/519,209 (2.9%) reports mentioned DM in women compared with 7,412/489,453 (1.5%) in men, which were both significantly higher than background (0.6%). Statins were primary-or secondary-suspected cause of the ADE significantly more often in women than men (59.8 vs. 28.7%), and reporting rates were disproportionately higher in women than in men for all statins. (reporting odds ratio 1.9 [95% CI 1.9-2.0]). The largest difference in reporting of statin-associated DM between women and women was observed with atorvastatin.ConclusionsAnalysis post-marketing spontaneous ADE reports demonstrated a higher reporting rate of DM-associated with statin use compared to other medications with a significantly higher reporting rate in women compared to men. Future studies should consider mechanisms of statin-associated DM moderated by sex.