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

Objective Determine whether statin-associated DM is reported more frequently in women than men in post-marketing adverse drug event (ADE) surveillance. Design Retrospective pharmacovigilance analysis Data source Publicly available FDA Adverse Event Reporting System (FAERS) from January 1997 through December 2023. Setting Real-world spontaneously reported ADEs in the United States. Participants Community patients reporting statin ADEs during the study period. Interventions/exposures Adverse drug event reports that included at least one statin. Main outcome measures Proportional 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. Results A 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. Conclusions Analysis 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.