Semaglutide: Nonarteritic Anterior Ischemic Optic Neuropathy in the FDA adverse event reporting system – A disproportionality analysis

IF 2.5 4区医学 Q3 ENDOCRINOLOGY & METABOLISM

Obesity research & clinical practice Pub Date : 2025-01-01 DOI:10.1016/j.orcp.2025.01.011

Marina Azab , Luca Pasina

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引用次数: 0

Abstract

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is used for type 2 diabetes (T2D) and approved for obesity by the FDA in 2022 and in Europe in 2023. Its increasing use has raised concerns about access for T2D patients and potential adverse events (AE), such as Nonarteritic Anterior Ischemic Optic Neuropathy (NAION). This study investigates the association between semaglutide and these AE using the FDA Adverse Event Reporting System (FAERS). We conducted a disproportionality analysis using FAERS data. AE were identified using MedDRA Preferred Terms (PTs) and related terms. OpenVigil 2.1 was used for data extraction and analysis. This system is a spontaneous safety surveillance database for drugs. The participants are patients who reported AE related to GLP-1 receptor agonists in the FAERS database from January 1, 2004, to September 30, 2024. Reporting Odds Ratios (ROR) and Proportional Reporting Ratios (PRR) were calculated to assess the association between GLP-1 receptor agonists and the AE. Semaglutide showed a significant ROR and PRR for NAION, suggesting a stronger association compared to other GLP-1 receptor agonists. The findings suggest a disproportionate reporting signal for semaglutide and NAION. The mechanisms behind these associations are not fully understood but may involve effects on the hypothalamus and vascular health. Further research is necessary to confirm these findings ensure the safe use of semaglutide, given the potential risk associated with this rare but severe adverse event.

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来源期刊

Obesity research & clinical practice 医学-内分泌学与代谢

CiteScore

7.10

自引率

0.00%

发文量

审稿时长

49 days

期刊介绍： The aim of Obesity Research & Clinical Practice (ORCP) is to publish high quality clinical and basic research relating to the epidemiology, mechanism, complications and treatment of obesity and the complication of obesity. Studies relating to the Asia Oceania region are particularly welcome, given the increasing burden of obesity in Asia Pacific, compounded by specific regional population-based and genetic issues, and the devastating personal and economic consequences. The journal aims to expose health care practitioners, clinical researchers, basic scientists, epidemiologists, and public health officials in the region to all areas of obesity research and practice. In addition to original research the ORCP publishes reviews, patient reports, short communications, and letters to the editor (including comments on published papers). The proceedings and abstracts of the Annual Meeting of the Asia Oceania Association for the Study of Obesity is published as a supplement each year.