Liu Dong, Zhang Xueni, Xu Haiyan
Department of Pharmacy, Nanchuan Hospital of Chongqing Medical University, Chongqing, China.
Expert Opin Drug Saf. 2025 Feb 1:1-9. doi: 10.1080/14740338.2025.2460444.
Pimavanserin is a new non-dopamine neurotransmitter antipsychotic drug. This study aimed to conduct a post-marketing pharmacovigilance study of pimavanserin, through data mining technology using the FDA Adverse Event Reporting System (FAERS) database.
We analyzed adverse event reports for patients using pimavanserin. Data were classified using systematic organ classification (SOC) and preferred term (PT) of the Medical Dictionary for Regular Activities (MedDRA). Four signal algorithms [reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma poisson shrinker (MGPS), and bayesian confidence propagation neural network (BCPNN)] were used to detect positive signals, and the median time-to-onset was determined.
Adverse drug events (ADEs) related to pimavanserin ( = 31,852) were analyzed, exhibiting an annual linear upward trend ( = 0.027). The ADEs involved 27 SOCs, but only 'Psychiatric disorders' simultaneously satisfied four algorithms. Overall, 153 PTs simultaneously satisfied four algorithms. Subgroup analysis of differences in the top 30 signal intensity PTs according to sex yielded significant results for seven PTs ( < 0.05). The median time-to-onset was 97 days, the highest proportion occurred within the first 30 days (31.79%).
Some new PT signals not listed in the label were identified, and some PT signals showed differences according to sex.
匹莫范色林是一种新型非多巴胺神经递质抗精神病药物。本研究旨在通过使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库的数据挖掘技术，对匹莫范色林进行上市后药物警戒研究。
我们分析了使用匹莫范色林患者的不良事件报告。数据使用医学常规活动词典（MedDRA）的系统器官分类（SOC）和首选术语（PT）进行分类。使用四种信号算法[报告比值比（ROR）、比例报告比值比（PRR）、多项目伽马泊松收缩器（MGPS）和贝叶斯置信传播神经网络（BCPNN）]来检测阳性信号，并确定中位发病时间。
分析了与匹莫范色林相关的药物不良事件（ADEs）（n = 31,852），呈年度线性上升趋势（r = 0.027）。ADEs涉及27个SOC，但只有“精神障碍”同时满足四种算法。总体而言，153个PT同时满足四种算法。根据性别对前30个信号强度PT的差异进行亚组分析，7个PT有显著结果（P < 0.05）。中位发病时间为97天，最高比例发生在最初30天内（31.79%）。
识别出了一些标签中未列出的新PT信号，一些PT信号存在性别差异。
