Abstract 18525: Sex Differences in Reporting of Statin-Associated Diabetes Mellitus - A Pharmacovigilance Analysis of Us Drug Safety Data

Introduction: Limited observational and clinical trial data have suggested a higher likelihood of statin-associated diabetes mellitus (DM) in women compared with men. However, real-world evidence of sex differences in statin-associated DM generally and with specific statins are lacking. Spontaneous adverse reporting pharmacovigilance systems provide an opportunity to assess these potential sex differences.

Hypothesis: Statin-associated DM is reported to the FDA disproportionately more in women than in men.

Methods: : Adverse event reports from the FDA Adverse Event Reporting System between 1960 and 2021 were obtained. Cases that included lovastatin, fluvastatin, pravastatin, simvastatin, atorvastatin, and rosuvastatin were analyzed together and individually with respect to reporting of DM vs. all other reactions starting at FDA approval of each. Signals of disproportionate reporting (SDR) were identified using the proportional reporting ratio (PRR) with a threshold of 2, and X2 of 4 with > 3 cases of reaction if interest. Differences between SDR in men vs. women were identified using a lower bound of the 95% confidence interval of the Reporting Odds Ratio (ROR) > 1 in > 3 events.

Results: In both men and women, DM was associated with a significantly elevated PRR for all statins combined and individually for atorvastatin, lovastatin, rosuvastatin, fluvastatin, simvastatin, and nominally for pitavastatin. Pravastatin was disproportionately reported in women only (M=1.80, W=2.32). Using ROR, statin-induced DM was reported significantly more frequently for atorvastatin, simvastatin, pravastatin, and rosuvastatin but not for pitavastatin, fluvastatin, or lovastatin.

Conclusions: Statin-associated DM is disproportionately reported to the FDA in both men and women for most agents compared with other adverse events. Importantly, statin-associated DM is reported significantly more in women than men for the statins most commonly used in current practice.