Luo Zhan-Yang, Li Xiang, Chen Cui-Ting, Kang Hong-Hua, Zhang Zhi-Jie, Wang Dong, Gong Jing-Ru
Department of Pharmacy, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China.
Eye Institute & Affiliated Xiamen Eye Center, School of Medicine, Xiamen University, Xiamen, Fujian, China.
Expert Opin Drug Saf. 2025 Mar;24(3):287-296. doi: 10.1080/14740338.2024.2419989. Epub 2024 Nov 7.
This study evaluates the risk of ocular adverse events (AEs) associated with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) using data from the FDA Adverse Event Reporting System (FAERS) and network pharmacology methods.
FAERS data from 2004 to 2024 were analyzed for ocular AEs linked to GLP-1 RA treatments. Disproportionality analysis (Reporting Odds Ratio, ROR) was used to identify signals, and a drug-gene interaction network explored potential mechanisms.
Among 17,785,793 FAERS reports, semaglutide and lixisenatide were significantly associated with ocular AEs, with RORs of 1.25 (95% CI, 1.20-1.31) and 1.96 (95% CI, 1.70-2.27), respectively. Commonly reported AEs included blurred vision, visual impairment, and diabetic retinopathy, with some AEs occurring as early as 10 days after treatment initiation. Gene enrichment analysis highlighted potential links between GLP-1-related genes and ocular AEs.
The widespread use of GLP-1 RAs has raised concerns regarding their ophthalmic safety. This study contributes new evidence from real-world data, suggesting that semaglutide and lixisenatide are associated with significant risks of ocular AEs. Further experimental studies are warranted to elucidate the underlying mechanisms and confirm these associations.
本研究利用美国食品药品监督管理局不良事件报告系统（FAERS）的数据和网络药理学方法，评估与胰高血糖素样肽-1受体激动剂（GLP-1 RAs）相关的眼部不良事件（AEs）风险。
分析2004年至2024年FAERS数据中与GLP-1 RA治疗相关的眼部AEs。采用不成比例分析（报告比值比，ROR）来识别信号，并构建药物-基因相互作用网络探索潜在机制。
在17785793份FAERS报告中，司美格鲁肽和利司那肽与眼部AEs显著相关，ROR分别为1.25（95%置信区间，1.20 - 1.31）和1.96（95%置信区间，1.70 - 2.27）。常见报告的AEs包括视力模糊、视觉障碍和糖尿病视网膜病变，部分AEs在治疗开始后10天就出现。基因富集分析突出了GLP-1相关基因与眼部AEs之间的潜在联系。
GLP-1 RAs的广泛使用引发了对其眼部安全性的担忧。本研究从真实世界数据中提供了新证据，表明司美格鲁肽和利司那肽与眼部AEs的显著风险相关。有必要进行进一步的实验研究以阐明潜在机制并证实这些关联。
