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与司美格鲁肽相关的视力损害报告增加:对美国食品药品监督管理局不良事件数据的分析

Increased vision impairment reports linked to semaglutide: analysis of FDA adverse event data.

作者信息

Massy Marine, Marti Stefanie, Hammer Helly, Hoepner Robert

机构信息

Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Rosenbühlgasse 25, Bern, CH-3010, Switzerland.

Graduate School for Cellular and Biomedical Sciences, University of Bern, Bern, Switzerland.

出版信息

BMC Med. 2025 Apr 7;23(1):203. doi: 10.1186/s12916-025-04031-z.

Abstract

BACKGROUND

Semaglutide, a GLP-1 receptor agonist widely prescribed for type 2 diabetes and obesity, has recently raised concerns about its ocular safety. This study aimed to investigate the association between semaglutide use and vision impairment using data from the FDA Adverse Event Reporting System (FAERS).

METHODS

We conducted an analysis of FAERS data, comparing reports of vision impairment associated with semaglutide to those associated with other antidiabetic and weight loss medications. The main outcome measure was the reporting odds ratio (rOR) for vision impairment linked to semaglutide use compared to other medications.

RESULTS

Semaglutide showed significantly higher reporting of vision impairment compared to other GLP-1 receptor agonists (rOR 1.95, 95% CI 1.75-2.17, p < 0.0001), DPP-4 inhibitors (rOR 2.46, 95% CI 2.12-2.86, p < 0.0001), SGLT2 inhibitors (rOR 3.89, 95% CI 3.35-4.51, p < 0.0001), and metformin (rOR 2.23, 95% CI 1.90-2.62, p < 0.0001). Similar findings were observed when compared to phentermine (rOR 1.57, 95% CI 1.07-2.31, p = 0.026) and orlistat (rOR 3.77, 95% CI 2.96-4.81, p < 0.0001). Topiramate was the sole exception, showing higher vision impairment reporting than semaglutide (rOR 0.30, 95% CI 0.20-0.45, p < 0.0001).

CONCLUSIONS

These findings suggest a potentially elevated risk of vision impairment with semaglutide use compared to other diabetes and weight loss medications, warranting further investigation and vigilant post-marketing surveillance. Future studies should assess the clinical impact of this potential increased risk on an absolute scale to better inform treatment decisions.

摘要

背景

司美格鲁肽是一种广泛用于治疗2型糖尿病和肥胖症的胰高血糖素样肽-1(GLP-1)受体激动剂,最近引起了人们对其眼部安全性的关注。本研究旨在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,调查司美格鲁肽的使用与视力损害之间的关联。

方法

我们对FAERS数据进行了分析,将与司美格鲁肽相关的视力损害报告与与其他抗糖尿病和减肥药物相关的报告进行比较。主要结局指标是与使用司美格鲁肽相比,其他药物导致视力损害的报告比值比(rOR)。

结果

与其他GLP-1受体激动剂相比,司美格鲁肽导致视力损害的报告显著更高(rOR 1.95,95%置信区间1.75-2.17,p<0.0001),与二肽基肽酶-4(DPP-4)抑制剂相比(rOR 2.46,95%置信区间2.12-2.86,p<0.0001),与钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂相比(rOR 3.89,95%置信区间3.35-4.51,p<0.0001),与二甲双胍相比(rOR 2.23,95%置信区间1.90-2.62,p<0.0001)。与苯丁胺相比(rOR 1.57,95%置信区间1.07-2.31,p=0.026)和奥利司他相比(rOR 3.77,95%置信区间2.96-4.81,p<0.0001)时也观察到类似结果。托吡酯是唯一的例外,其视力损害报告率高于司美格鲁肽(rOR 0.30,95%置信区间0.20-0.45,p<0.0001)。

结论

这些发现表明,与其他糖尿病和减肥药物相比,使用司美格鲁肽导致视力损害的风险可能升高,值得进一步研究和进行上市后密切监测。未来的研究应从绝对规模评估这种潜在增加风险的临床影响,以便更好地为治疗决策提供依据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33d9/11974072/78cb3f0dde20/12916_2025_4031_Fig1_HTML.jpg

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