Adverse drug events associated with metreleptin administration: a real-world pharmacovigilance study from 2014 to 2024 using the FAERS database

This study analyzed adverse drug event (ADE) signals associated with metreleptin using the FDA Adverse Event Reporting System (FAERS) to provide insights for safe clinical use.
Data from 1 January 2014, to 31 March 2024, were extracted. Signal intensity for adverse events was assessed using reporting odds ratio (ROR), Medicines and Healthcare Products Regulatory Agency (MHRA), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) methods. Time-to-onset (TTO) correlations were evaluated using the Weibull shape parameter (WSP). Logistic regression identified potential hospitalization risk factors.
4,000 ADE reports were identified, with 1,025 significant events mainly involving females (66.73%) and reported by healthcare professionals (67.80%), primarily from the United States (84.10%). 101 preferred term (PT) signals were confirmed by all methods, with 57 PTs not listed on the drug label. Overall TTO was 547 days (IQR: 113–1325), with gastrointestinal disorders and investigations as hospitalization risk factors.
This study provides critical insights into the TTO of ADEs related to metreleptin, informing safe clinical application and emphasizing the importance of monitoring potential side effects.

本研究借助FDA不良事件报告系统（FDA Adverse Event Reporting System, FAERS），分析了美曲普汀（metreleptin）相关的药物不良事件（adverse drug event, ADE）信号，以期为临床安全用药提供参考。
研究提取了2014年1月1日至2024年3月31日的相关数据。采用报告比值比（reporting odds ratio, ROR）、英国药品与医疗保健产品监管署（Medicines and Healthcare Products Regulatory Agency, MHRA）法、贝叶斯置信传播神经网络（Bayesian Confidence Propagation Neural Network, BCPNN）法以及多项目伽马泊松收缩器（Multi-item Gamma Poisson Shrinker, MGPS）法，对不良事件的信号强度进行评估。采用威布尔形状参数（Weibull shape parameter, WSP）评估不良事件发生时间（time-to-onset, TTO）的相关性。通过逻辑回归分析识别潜在的住院风险因素。
本研究共纳入4000份药物不良事件报告，其中1025例为显著不良事件，受试者以女性为主（占比66.73%），报告者多为医疗专业人员（占比67.80%），报告主要来自美国（占比84.10%）。经所有方法验证确认的首选术语（preferred term, PT）信号共101个，其中57个未收录于药品说明书。整体不良事件发生时间中位数为547天（四分位距：113~1325），胃肠道疾病与检查指标异常为住院风险因素。
本研究深入剖析了美曲普汀相关药物不良事件的发生时间特征，可为临床安全应用提供关键参考依据，并强调了监测潜在不良反应的重要性。