胰高血糖素样肽-1 受体激动剂意外用药过量报告的增加:一项基于人群的研究。

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-11-19 DOI:10.1080/14740338.2024.2430306
Roger S McIntyre, Angela T H Kwan
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引用次数: 0

摘要

背景:使用网上药店和/或复合药店购买胰高血糖素样肽-1 受体激动剂(GLP-1 RAs)会增加处方错误(如意外用药过量)的风险,尤其是在种族、民族和社会经济弱势群体中:我们试图评估向美国 FDA 不良事件报告系统 (FAERS) 提交的与 GLP-1 RA 相关的意外用药过量情况。使用 OpenVigil 2.1 检索了 2003 年第四季度至 2024 年第一季度向 FAERS 报告的意外用药过量病例报告。意外用药过量的比例失调采用报告几率比(ROR)进行评估。上、下95%置信区间(CI)按5%的α水平计算,当下95%CI大于1.0时,则认为报告不成比例:我们发现了 3,348 例与 GLP-1 RAs 相关的意外用药过量报告。该类药物中所有药物的 ROR 均有显著性(ROR 范围:2.64-61.12,均为 p):GLP-1 RAs 的可及性、可获得性和可负担性不足,导致越来越多的人通过网上和/或复合药房购买 GLP-1 RAs,这与处方错误的风险增加有关,而处方错误对种族、民族和社会经济弱势群体的影响各不相同。药物警戒数据库分析不能确定因果关系,只能确定关联关系。
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Increased reporting of accidental overdose with glucagon-like peptide-1 receptor agonists: a population-based study.

Background: The use of online and/or compounding pharmacies to access glucagon-like peptide-1 receptor agonists (GLP-1 RAs) increases the risk for prescription error (e.g. accidental overdose) especially in racial, ethnic, and socioeconomic disadvantaged groups.

Methods: We sought to evaluate accidental overdose associated with GLP-1 RAs submitted to the United States FDA Adverse Event Reporting System (FAERS). Case reports of accidental overdose reported to the FAERS were retrieved from Q4 2003 to Q1 2024 using OpenVigil 2.1. Disproportionality of accidental overdose was assessed using reporting odds ratio (ROR). Upper and lower 95% confidence intervals (CI) were calculated at an alpha level of 5%, where disproportionate reporting was considered when the lower 95% CI was greater than 1.0.

Results: We identified 3,348 reports of accidental overdose associated with GLP-1 RAs. The RORs were significant for all agents within the class (ROR range: 2.64-61.12, all p < 0.008), including semaglutide, dulaglutide, exenatide, liraglutide, and tirzepatide compared to niacin.

Conclusions: Inadequate access, availability, and affordability of GLP-1 RAs has contributed to the increased seeking via online and/or compounding pharmacies, and is associated with greater risk for prescription errors that differentially affect racial, ethnic, and socioeconomic vulnerable populations. Pharmacovigilance database analyses cannot establish causation only association.

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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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