利拉鲁肽和司美格鲁肽在体重管理方面的真实世界安全性比较：来自欧洲药物警戒数据的见解

Real-world safety comparison of liraglutide and semaglutide in weight management: Insights from European pharmacovigilance data.

作者信息

Ruggiero Rosanna, Longo Miriam, Mascolo Annamaria, Di Nuzzo Michela, Laino Ludovica Vittoria, Caruso Paola, D'Amato Rossana, Rafaniello Concetta, Maiorino Maria Ida, Esposito Katherine, Capuano Annalisa

机构信息

Department of Life Science, Health, and Health Professions, Link Campus University, Roma, Italy; Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138, Naples, Italy; Department of Experimental Medicine, Section of Pharmacology "L. Donatelli", University of Campania "Luigi Vanvitelli", 80138, Naples, Italy.

Department of Life Science, Health, and Health Professions, Link Campus University, Roma, Italy; Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", 80138, Naples, Italy.

出版信息

Eur J Pharmacol. 2025 Oct 5;1004:178004. doi: 10.1016/j.ejphar.2025.178004. Epub 2025 Jul 25.

DOI:10.1016/j.ejphar.2025.178004

PMID:40716637

Abstract

BACKGROUND

In recent years, the use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), as liraglutide and semaglutide, for weight management has significantly risen. Even if these medications are effective, some concerns remain about their safety profiles, particularly regarding long-term adverse events (AEs). This study provides an evaluation of the safety profiles of liraglutide and semaglutide in a real-world setting.

METHODS

A retrospective case-non-case study was conducted using data from the EudraVigilance database. All cases involving liraglutide or semaglutide used for weight management and collected in the database between January 2018 and December 2023 were analyzed. Disproportionality analysis was performed to assess the reporting odds ratios for events of interest (gastrointestinal events, pancreatitis, gallbladders disorders, psychiatric events, and gallbladder, pancreatic or thyroid tumors) reported at least three times.

RESULTS

A total of 27,639 cases were identified. Most cases occurred in female patients aged 18-64 years. Most reported AEs were not-serious. Gastrointestinal events were the most common, with nausea, vomiting, and diarrhea leading the list. Two events were related to gallbladder tumors. Disproportionality analysis revealed that liraglutide was associated with a higher reporting frequency of pancreatitis, gallbladder disorders, and thyroid tumors, while semaglutide showed a greater likelihood of vomiting and abdominal pain. No significant differences were found for other common gastrointestinal events, pancreatic tumors, depression, or suicidal ideation.

CONCLUSIONS

Liraglutide and semaglutide showed distinct safety profiles when used for weight management. These findings highlight the importance of considering individual patient profiles and potential risks when prescribing these medications for weight management. Further real-world studies are needed to explore long-term safety and to clarify the potential association between GLP-1 RAs and malignancies.

摘要

背景

近年来，利拉鲁肽和司美格鲁肽等胰高血糖素样肽-1受体激动剂（GLP-1 RAs）用于体重管理的情况显著增加。即使这些药物有效，但人们对其安全性仍存在一些担忧，尤其是关于长期不良事件（AE）。本研究对利拉鲁肽和司美格鲁肽在实际应用中的安全性进行了评估。

方法

使用欧洲药物警戒数据库（EudraVigilance database）的数据进行回顾性病例对照研究。分析了2018年1月至2023年12月期间数据库中所有涉及用于体重管理的利拉鲁肽或司美格鲁肽的病例。进行了不成比例分析，以评估至少报告三次的感兴趣事件（胃肠道事件、胰腺炎、胆囊疾病、精神事件以及胆囊、胰腺或甲状腺肿瘤）的报告比值比。

结果

共识别出27639例病例。大多数病例发生在18 - 64岁的女性患者中。大多数报告的不良事件不严重。胃肠道事件最为常见，恶心、呕吐和腹泻位居前列。有两起事件与胆囊肿瘤有关。不成比例分析显示，利拉鲁肽与胰腺炎、胆囊疾病和甲状腺肿瘤的报告频率较高相关，而司美格鲁肽出现呕吐和腹痛的可能性更大。在其他常见胃肠道事件、胰腺肿瘤、抑郁或自杀意念方面未发现显著差异。