与西马鲁肽相关的视力损害报告增加:FDA不良事件数据分析

IF 7 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Marine Massy, Stefanie Marti, Helly Hammer, Robert Hoepner
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引用次数: 0

摘要

背景:Semaglutide是一种广泛用于2型糖尿病和肥胖的GLP-1受体激动剂,最近引起了人们对其眼部安全性的担忧。本研究旨在利用FDA不良事件报告系统(FAERS)的数据调查西马鲁肽使用与视力损害之间的关系。方法:我们对FAERS数据进行了分析,比较了与西马鲁肽相关的视力损害报告与与其他降糖药和减肥药相关的报告。主要结局指标是与其他药物相比,使用西马鲁肽与视力损害相关的报告优势比(rOR)。结果:与其他GLP-1受体激动剂相比,西马鲁肽的视力损害报告率显著高于其他GLP-1受体激动剂(rOR 1.95, 95% CI 1.75-2.17, p)。结论:这些发现表明,与其他糖尿病和减肥药物相比,使用西马鲁肽可能会增加视力损害的风险,值得进一步调查和警惕的上市后监测。未来的研究应该在绝对尺度上评估这种潜在风险增加的临床影响,以便更好地为治疗决策提供信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Increased vision impairment reports linked to semaglutide: analysis of FDA adverse event data.

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.

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来源期刊
BMC Medicine
BMC Medicine 医学-医学:内科
CiteScore
13.10
自引率
1.10%
发文量
435
审稿时长
4-8 weeks
期刊介绍: BMC Medicine is an open access, transparent peer-reviewed general medical journal. It is the flagship journal of the BMC series and publishes outstanding and influential research in various areas including clinical practice, translational medicine, medical and health advances, public health, global health, policy, and general topics of interest to the biomedical and sociomedical professional communities. In addition to research articles, the journal also publishes stimulating debates, reviews, unique forum articles, and concise tutorials. All articles published in BMC Medicine are included in various databases such as Biological Abstracts, BIOSIS, CAS, Citebase, Current contents, DOAJ, Embase, MEDLINE, PubMed, Science Citation Index Expanded, OAIster, SCImago, Scopus, SOCOLAR, and Zetoc.
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