Neuropsychiatric adverse events associated with Glucagon-like peptide-1 receptor agonists: a pharmacovigilance analysis of the FDA Adverse Event Reporting System database.

IF 6.7 2区 医学 Q1 PSYCHIATRY
Wenchao Lu, Shihan Wang, Huilin Tang, Tao Yuan, Wei Zuo, Yuling Liu
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引用次数: 0

Abstract

Background: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are widely used due to their profound efficacy in glycemic control and weight management. Real-world observations have revealed potential neuropsychiatric adverse events (AEs) associated with GLP-1RAs. This study aimed to comprehensively investigate and characterize these neuropsychiatric AEs with GLP-1RAs.

Methods: We analyzed GLP-1RA adverse reaction reports using the FDA Adverse Event Reporting System database. Disproportionality analysis using reporting odds ratio (ROR) identified eight categories of neuropsychiatric AEs associated with GLP-1RAs. We conducted descriptive and time-to-onset (TTO) analyses and explored neuropsychiatric AE signals among individual GLP-1RAs for weight loss and diabetes mellitus (DM) indications.

Results: We identified 25,110 cases of GLP-1RA-related neuropsychiatric AEs. GLP-1RAs showed an association with headache (ROR 1.74, 95% confidence interval [CI] 1.65-1.84), migraine (ROR 1.28, 95%CI 1.06-1.55), and olfactory and sensory nerve abnormalities (ROR 2.44, 95%CI 1.83-3.25; ROR 1.69, 95%CI 1.54-1.85). Semaglutide showed a moderate suicide-related AEs signal in the weight loss population (ROR 2.55, 95%CI 1.97-3.31). The median TTO was 16 days (interquartile range: 3-66 days).

Conclusions: In this study, we identified eight potential neuropsychiatric adverse events (AEs) associated with GLP-1RAs and, for the first time, detected positive signals for migraine, olfactory abnormalities, and sensory abnormalities. We also observed positive suicide-related signals of semaglutide, in weight loss population. This study provides a reliable basis for further investigation of GLP-1RA-related neuropsychiatric AEs. However, as an exploratory study, our findings require confirmation through large-scale prospective studies.

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与胰高血糖素样肽-1受体激动剂相关的神经精神不良事件:FDA不良事件报告系统数据库的药物警戒分析
背景:胰高血糖素样肽-1受体激动剂(Glucagon-like peptide-1 receptor agonists, GLP-1RAs)因其在血糖控制和体重管理方面的显著疗效而被广泛应用。现实世界的观察揭示了与GLP-1RAs相关的潜在神经精神不良事件(ae)。本研究旨在用GLP-1RAs对这些神经精神ae进行全面调查和表征。方法:我们使用FDA不良事件报告系统数据库分析GLP-1RA不良反应报告。使用报告优势比(ROR)的歧化分析确定了与GLP-1RAs相关的八类神经精神ae。我们进行了描述性和发病时间(TTO)分析,并探讨了体重减轻和糖尿病(DM)适应症中个体GLP-1RAs的神经精神AE信号。结果:我们确定了25,110例glp - 1ra相关的神经精神ae。GLP-1RAs与头痛(ROR 1.74, 95%可信区间[CI] 1.65-1.84)、偏头痛(ROR 1.28, 95%CI 1.06-1.55)、嗅觉和感觉神经异常(ROR 2.44, 95%CI 1.83-3.25;or 1.69, 95%ci 1.54-1.85)。西马鲁肽在减肥人群中显示出中度自杀相关ae信号(ROR 2.55, 95%CI 1.97-3.31)。中位TTO为16天(四分位数范围:3-66天)。结论:在这项研究中,我们确定了8种与GLP-1RAs相关的潜在神经精神不良事件(ae),并首次发现偏头痛、嗅觉异常和感觉异常的阳性信号。在减肥人群中,我们也观察到西马鲁肽的阳性自杀相关信号。本研究为进一步研究glp - 1ra相关的神经精神ae提供了可靠的基础。然而,作为一项探索性研究,我们的发现需要通过大规模的前瞻性研究来证实。
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来源期刊
European Psychiatry
European Psychiatry 医学-精神病学
CiteScore
8.50
自引率
3.80%
发文量
2338
审稿时长
4.5 weeks
期刊介绍: European Psychiatry, the official journal of the European Psychiatric Association, is dedicated to sharing cutting-edge research, policy updates, and fostering dialogue among clinicians, researchers, and patient advocates in the fields of psychiatry, mental health, behavioral science, and neuroscience. This peer-reviewed, Open Access journal strives to publish the latest advancements across various mental health issues, including diagnostic and treatment breakthroughs, as well as advancements in understanding the biological foundations of mental, behavioral, and cognitive functions in both clinical and general population studies.
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