Association between glucagon-like peptide-1 agonists and risk of diabetic retinopathy: a disproportionality analysis using FDA adverse event reporting system data.

BACKGROUND

Glucagon-like peptide-1 (GLP-1) agonists are commonly prescribed for type 2 diabetes mellitus (T2DM). Concerns have emerged regarding their potential link to diabetic retinopathy (DR).

METHODS

To evaluate the association between GLP-1 agonists and DR, a disproportionality analysis was conducted using FDA Adverse Event Reporting System (FAERS) data from Q4/2003 to Q2/2024 via OpenVigil 2.1 software. We focused on GLP-1 agonists and glucose-dependent insulinotropic polypeptide (GIP) agonist: Semaglutide, liraglutide, dulaglutide, lixisenatide, and tirzepatide, as primary suspect drugs. 'Diabetic retinopathy' was the key search term mapped to Medical Dictionary for Regulatory Activities (MedDRA) Lower-Level Terms (LLTs). We calculated Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR), with 95% confidence intervals (CI) and the Evans' criteria were applied to check the significant associations.

RESULTS

Semaglutide (PRR: 19.43, 95% CI: 15.17-24.88; ROR: 19.48, 95% CI: 15.20-24.96; Chi-square: 1078.08) and dulaglutide (PRR: 9.01, 95% CI: 7.11-11.42; ROR: 9.02, 95% CI: 7.11-11.44; Chi-square: 478.31) showed a strong association with DR. Tirzepatide and liraglutide showed a weaker but significant association while lixisenatide showed no significant association.

CONCLUSION

GLP-1 agonists (except lixisenatide) were found to be associated with DR. These findings emphasize the need for close monitoring and further research to clarify these associations.