Women are nearly twice as likely as men to report statin-associated diabetes mellitus, with atorvastatin showing the highest reporting disparity, according to Food and Drug Administration’s Adverse Event Reporting System data.

Researchers conducted a comprehensive analysis of sex differences in the reporting of statin-associated diabetes mellitus (DM) using data from the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS). The study analyzed adverse drug event (ADE) reports from January 1997 to December 2023 to assess whether DM events associated with statins were disproportionately reported in women compared with men.

The analysis included 18,294,814 ADEs submitted to FAERS, of which 1,073,946 mentioned at least one statin. Researchers focused on ADEs involving atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin. DM cases were identified using Medical Dictionary for Regulatory Activities terms, and the proportional reporting ratio (PRR) and reporting odds ratio (ROR) were used to compare reporting rates by sex.

Key findings revealed that DM was reported in 2.9% of statin-associated ADEs in women and 1.5% in men, both significantly higher than the background rate of 0.6% observed with other medications. The ROR comparing women to men for all statins combined was 1.9 (95% confidence interval [CI]: 1.9–2.0), indicating a nearly twofold greater likelihood of DM reporting in women. Among individual statins, atorvastatin exhibited the greatest disparity, with a PRR of 8.1 in women compared to 2.9 in men and an ROR of 3.0 (95% CI: 2.9–3.1). In contrast, pravastatin had the lowest overall PRR (2.1) and a smaller sex-specific difference (ROR: 1.2; 95% CI: 1.1–1.4).

Published in the journal BMJ Open Diabetes Research & Care, the study also found that statins were identified as the primary or secondary suspect in 60% of DM-associated ADEs reported in women compared with 30% in men. However, men exhibited higher rates of hospitalization (37% vs. 20%) and mortality (8% vs. 3%) linked to these events.

This study faced several limitations typical of pharmacovigilance analyses, particularly those relying on spontaneous reporting systems like FAERS, which capture only a fraction of ADEs and often lack comprehensive demographic and clinical details. The inability to adjust for confounders such as age, sex, race, or comorbidities, combined with missing data on statin doses and treatment timing, limits the ability to derive precise estimates or draw causal conclusions from observed reporting differences.

The findings underscore a significant sex difference in statin-associated DM reporting trends, highlighting the need for personalized approaches to statin therapy while acknowledging that these observations do not reflect absolute risk differences due to the limitations of FAERS data. The authors highlight the need for further research to elucidate underlying mechanisms and evaluate statin selection and monitoring strategies based on sex differences.

Full disclosures can be found in the published study.