Zhang Jing, Wang Xiaofen, Zhou Yiting
Department of Pharmacy, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Clinical Laboratory, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Front Pharmacol. 2024 Oct 22;15:1471615. doi: 10.3389/fphar.2024.1471615. eCollection 2024.
Compared to alternative weight-loss strategies and medications, semaglutide stands out for its convenience and efficacy, resulting in a significant increase in prescriptions and raising public safety concerns. Furthermore, the safety profiles of its oral and subcutaneous formulations require further examination.
Our goal is to investigate the potential safety risks associated with semaglutide by analyzing data from the FAERS database and social media. Additionally, we aim to compare the adverse drug reaction (ADR) signals between the oral and subcutaneous administration routes of semaglutide.
We collected semaglutide-related reports from the FAERS database spanning Q1 2018 to Q2 2023, and patient reviews on WebMD and AskaPatient up to 20 July 2023. Following data extraction and cleansing, we conducted descriptive analyses of demographic characteristics. Subsequently, we calculated adverse drug reaction (ADR) signals using the reporting odds ratio (ROR).
We identified 19,289 and 422 semaglutide-related adverse drug events (ADEs) reported in the FAERS database and online patient reviews, respectively. Gastrointestinal disorders emerged as the most commonly reported System Organ Class (SOC) in both datasets. Predominant Preferred Terms (PTs) included nausea, vomiting, and diarrhea. Serious outcomes constituted 3.07% and 2.25% of all cases for oral and subcutaneous semaglutide, respectively. At the SOC level, gastrointestinal disorders accounted for 30.19% of total ADEs in oral semaglutide, slightly surpassing the 27.76% in subcutaneous semaglutide. The median onset for gastrointestinal PTs was 4 days in both oral (Q1: 1, Q3: 32) and subcutaneous (Q1: 1, Q3: 35) formulations. Noteworthy, new serious adverse event (AE) signals were identified, including hemorrhagic diarrhea (ROR: 3.69), hepatic pain (ROR: 4.20), abnormal hormone levels (ROR: 6.51), and pancreatic failure (ROR: 36.34) in subcutaneous semaglutide, and Dupuytren's contracture (ROR: 46.85) in oral semaglutide.
Our study delineates the safety profile of semaglutide using data from the FAERS database and social media. And identified novel ADR signals specific to oral and subcutaneous forms of semaglutide.
与其他减肥策略和药物相比，司美格鲁肽因其便利性和有效性脱颖而出，导致处方量显著增加，并引发了公众安全担忧。此外，其口服和皮下注射剂型的安全性也需要进一步研究。
我们的目标是通过分析来自美国食品药品监督管理局不良事件报告系统（FAERS）数据库和社交媒体的数据，调查与司美格鲁肽相关的潜在安全风险。此外，我们旨在比较司美格鲁肽口服和皮下注射给药途径之间的药物不良反应（ADR）信号。
我们收集了2018年第一季度至2023年第二季度FAERS数据库中与司美格鲁肽相关的报告，以及截至2023年7月20日WebMD和AskaPatient上的患者评论。在进行数据提取和清理后，我们对人口统计学特征进行了描述性分析。随后，我们使用报告比值比（ROR）计算药物不良反应（ADR）信号。
我们分别在FAERS数据库和在线患者评论中确定了19289例和422例与司美格鲁肽相关的药物不良事件（ADE）。胃肠道疾病是两个数据集中报告最常见的系统器官分类（SOC）。主要的首选术语（PT）包括恶心、呕吐和腹泻。严重后果分别占口服和皮下注射司美格鲁肽所有病例的3.07%和2.25%。在SOC层面，胃肠道疾病在口服司美格鲁肽的总ADE中占30.19%，略高于皮下注射司美格鲁肽的27.76%。口服（第一四分位数：1，第三四分位数：32）和皮下注射（第一四分位数：1，第三四分位数：35）剂型的胃肠道PT的中位发病时间均为4天。值得注意的是，我们发现了新的严重不良事件（AE）信号，包括皮下注射司美格鲁肽的出血性腹泻（ROR：3.69）、肝痛（ROR：4.20）、激素水平异常（ROR：6.51）和胰腺衰竭（ROR：36.34），以及口服司美格鲁肽的掌腱膜挛缩（ROR：46.85）。
我们的研究利用FAERS数据库和社交媒体的数据描绘了司美格鲁肽的安全性概况，并确定了口服和皮下注射形式的司美格鲁肽特有的新ADR信号。
