Osei Samuel Prince, Akomaning Edwin, Florut Teodora Francesca, Sodhi Mohit, Lacy Brian E, Aldhaleei Wafa A, Bhagavathula Akshaya Srikanth
Department of Public Health, North Dakota State University, Fargo, ND 58108, USA.
Faculty of Health Sciences, Simon Fraser University, Burnaby, BC V5A 1S6, Canada.
Diagnostics (Basel). 2024 Dec 16;14(24):2829. doi: 10.3390/diagnostics14242829.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are commonly used to treat obesity and diabetes but are linked to a variety of gastrointestinal (GI) adverse events (AEs). Real-world data on GLP-1 RA-related GI AEs and outcomes are limited. This study assessed GI AEs and adverse outcomes using the US FDA Adverse Event Reporting System (FAERS). This retrospective pharmacovigilance study used the US FDA FAERS database (2007-2023). We searched GLP-1 RA medications, AEs, and adverse outcomes. Demographic, treatment indication, and AE data were collected. Descriptive analysis involved frequencies and percentages, while reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multivariate logistic regression were used to analyze GLP-1 RA-related GI AEs and outcomes. From 2007 to 2023, a total of 187,757 AEs were reported with GLP-1 RAs, and 16,568 were GLP-1 RA-associated GI AEs in the US. Semaglutide was linked to higher odds of nausea (IC: 0.151, β: 0.314), vomiting (IC: 0.334, β: 0.495), and delayed gastric emptying (IC: 0.342, β: 0.453). Exenatide was associated with pancreatitis (IC: 0.601, β: 0.851) and death (ROR: 4.50, IC: 1.101). Overall, semaglutide had a broader range of notable adverse effects; by comparison, dulaglutide and liraglutide use was associated with fewer significant GI AEs. Analysis of the FAERS data reveals that GLP-1 RAs, particularly semaglutide and exenatide, are significantly associated with specific GI AEs, such as nausea, vomiting, delayed gastric emptying, and pancreatitis. Clinicians should be aware of these potential risks to ensure optimal monitoring and patient safety. This study demonstrated the utility of pharmacovigilance data in identifying safety signals, which can inform future pharmacoepidemiological investigations to confirm causal relationships. Clinicians should be aware of these potential risks to ensure optimal monitoring and patient safety.
胰高血糖素样肽-1受体激动剂（GLP-1 RAs）常用于治疗肥胖症和糖尿病，但与多种胃肠道（GI）不良事件（AEs）相关。关于GLP-1 RA相关胃肠道不良事件及结局的真实世界数据有限。本研究使用美国食品药品监督管理局不良事件报告系统（FAERS）评估胃肠道不良事件及不良结局。这项回顾性药物警戒研究使用了美国食品药品监督管理局FAERS数据库（2007 - 2023年）。我们搜索了GLP-1 RA药物、不良事件及不良结局。收集了人口统计学、治疗指征和不良事件数据。描述性分析涉及频率和百分比，同时使用报告比值比（ROR）、比例报告比、贝叶斯置信传播神经网络和多变量逻辑回归分析GLP-1 RA相关胃肠道不良事件及结局。2007年至2023年期间，美国共报告了187,757例与GLP-1 RAs相关的不良事件，其中16,568例为GLP-1 RA相关的胃肠道不良事件。司美格鲁肽与恶心（IC：0.151，β：0.314）、呕吐（IC：0.334，β：0.495）和胃排空延迟（IC：0.342，β：0.453）的较高几率相关。艾塞那肽与胰腺炎（IC：0.601，β：0.851）和死亡（ROR：4.50，IC：1.101）相关。总体而言，司美格鲁肽有更广泛的显著不良反应；相比之下，度拉鲁肽和利拉鲁肽使用相关的严重胃肠道不良事件较少。对FAERS数据的分析表明，GLP-1 RAs，尤其是司美格鲁肽和艾塞那肽，与特定的胃肠道不良事件显著相关，如恶心、呕吐、胃排空延迟和胰腺炎。临床医生应意识到这些潜在风险，以确保进行最佳监测和患者安全。本研究证明了药物警戒数据在识别安全信号方面的作用，这可为未来的药物流行病学调查提供信息以确认因果关系。临床医生应意识到这些潜在风险，以确保进行最佳监测和患者安全。
