GLP-1受体激动剂的前庭听觉不良事件报告特征：一项使用FDA AEMS数据的病例-病例药物警戒研究。
Audiovestibular adverse event reporting profiles of GLP-1 receptor agonists: A case-case pharmacovigilance study using FDA AEMS data.
文献信息
| PMID | 42867646 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Xianwen Wang |
| 作者单位 | Department of Otolaryngology, Shenzhen Hospital, Southern Medical University, Shenzhen, 518100, China. |
| 期刊 | European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery |
| SCI 分区 | Q1 |
| IF | 2.3 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 耳科 |
中文摘要
目的： 在美国食品药品监督管理局不良事件监测系统（AEMS）中，描述并比较胰高血糖素样肽-1受体激动剂（GLP-1 RAs）的前庭听觉不良事件报告模式。
方法： 我们对截至2026年第一季度的AEMS报告进行了回顾性病例级分析。将艾塞那肽、利拉鲁肽、度拉糖肽、利司那肽或司美格鲁肽列为主要可疑药物且包含至少一个预设前庭听觉MedDRA首选术语的报告按病例去重。在代表性充分的药物中，使用卡方检验比较表型构成，并对六个常见首选术语计算病例-病例比较报告比值比（cROR），采用Benjamini-Hochberg校正。对发病时间（TTO）进行描述性总结。
结果： 我们识别出1,950份唯一报告：艾塞那肽576份、利拉鲁肽192份、度拉糖肽622份、利司那肽1份、司美格鲁肽559份。听力减退（46.9%）、眩晕（27.7%）、耳鸣（12.7%）和耳聋（7.9%）最为常见。四种代表性充分药物的表型构成存在差异（卡方=78.12，P<0.001；Cramer V=0.142）。度拉糖肽报告富集听力减退（cROR 3.06，95% CI 2.51-3.74），而利拉鲁肽和司美格鲁肽报告富集眩晕和耳鸣。中位TTO为3天（IQR 0-35），但仅19.3%的报告有有效日期。
结论： 各GLP-1 RA显示出不同的前庭听觉报告构成。这些发现具有假设生成性，不能确立发生率、比较安全性或因果关系。
英文摘要
PURPOSE: To characterize and compare audiovestibular adverse-event reporting patterns among glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in the US Food and Drug Administration Adverse Event Monitoring System (AEMS).
METHODS: We performed a retrospective case-level analysis of AEMS reports through 2026 Q1. Reports naming exenatide, liraglutide, dulaglutide, lixisenatide, or semaglutide as the primary suspect and containing at least one prespecified audiovestibular MedDRA preferred term were deduplicated by case. Among adequately represented agents, phenotype composition was compared using chi-square testing, and case-case comparative reporting odds ratios (cRORs) were calculated for six common preferred terms with Benjamini-Hochberg correction. Time to onset (TTO) was summarized descriptively.
RESULTS: We identified 1,950 unique reports: exenatide 576, liraglutide 192, dulaglutide 622, lixisenatide 1, and semaglutide 559. Hypoacusis (46.9%), vertigo (27.7%), tinnitus (12.7%), and deafness (7.9%) were most frequent. Phenotype composition differed across the four adequately represented agents (chi-square = 78.12, P < 0.001; Cramer V = 0.142). Dulaglutide reports were enriched for hypoacusis (cROR 3.06, 95% CI 2.51-3.74), whereas liraglutide and semaglutide reports were enriched for vertigo and tinnitus. Median TTO was 3 days (IQR 0-35), but valid dates were available for only 19.3% of reports.
CONCLUSION: Individual GLP-1 RAs showed distinct audiovestibular reporting compositions. These findings are hypothesis-generating and do not establish incidence, comparative safety, or causality.