Sex-differences in reporting of statin-associated diabetes mellitus to the US Food and Drug Administration
Authors' conclusion
Analysis of post-marketing spontaneous ADE reports demonstrated a higher reporting rate of DM-associated with statin use compared with other medications with a significantly higher reporting rate in women compared with men. Future studies should consider mechanisms of statin-associated DM moderated by sex.
Study context
- Population
- Spontaneously reported adverse drug events submitted to the FDA Adverse Event Reporting System, January 1997–December 2023, mentioning atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin
- Participants
- 18,294,814 ADE reports
- Exposure
- Statin-associated diabetes mellitus (DM) reporting in women vs men
- Outcome
- Reporting of statin-associated DM events in women vs men (reporting OR)
Methodological detailsspontaneously reported adverse drug events (ADEs), FDA Adverse Event Reporting System, proportional reporting ratio, reporting OR
- Spontaneously reported ADEs
- FDA Adverse Event Reporting System
- Proportional reporting ratio
- Reporting OR
Main finding
Statin-associated ADE reports mentioning DM
Reporting OR
1.9
95% CI 1.9–2.0
Events by group
Between Women and Men
reporting OR 1.9 (95% CI 1.9–2.0)
As reported in the abstract
- Both significantly higher than background
- 0.6%
Observational data: associations, not effects.
Further findings
Statins primary- or secondary-suspected cause of the ADE
Individual statins
- Reporting rates disproportionately higher in women than men for all statins; largest difference with atorvastatin
Original publication
Sex-differences in reporting of statin-associated diabetes mellitus to the US Food and Drug Administration. BMJ Open Diabetes Res Care. Published 5 December 2024. doi:10.
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