Xia Chunyong, Liu Zhijing, Liu Jie, Lin Li, Chen Maohua
Department of Pharmacy, Chongqing university jiangjin hospital, Jiang jin 402260, Chongqing, China.
Department of Pharmacy, Affiliated Hospital of Putian University, Pu Tian 351100, Fujian, China.
Invest New Drugs. 2024 Oct;42(5):500-509. doi: 10.1007/s10637-024-01457-9. Epub 2024 Aug 12.
Relugolix has been used to treat advanced prostate cancer. This study assessed adverse events (AEs) associated with relugolix from the US Food and Drug Administration Adverse Event Reporting System (FAERS).
Disproportionality analysis, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms, were employed to quantify the signals of relugolix-associated AEs.
A total of 5,059,213 reports of AEs were collected from the FAERS database, of which 5,662 reports were identified with relugolix as the "primary suspect (PS)". A total of 70 significant disproportionality PTs conforming to the four algorithms were simultaneously retained. Unexpected new AEs, such as erectile dysfunction, gynaecomastia, testicular atrophy, male genital atrophy, libido decreased might also occur.
This study found potential new AEs signals and might provide important support for clinical monitoring and risk identification of relugolix.
relugolix已被用于治疗晚期前列腺癌。本研究通过美国食品药品监督管理局不良事件报告系统（FAERS）评估了与relugolix相关的不良事件（AE）。
采用不成比例分析，包括报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS）算法，对relugolix相关AE的信号进行量化。
从FAERS数据库共收集到5059213份AE报告，其中5662份报告将relugolix识别为“主要怀疑对象（PS）”。同时保留了符合四种算法的70种显著不成比例的首选术语（PT）。还可能出现意外的新AE，如勃起功能障碍、男性乳房发育、睾丸萎缩、男性生殖器萎缩、性欲减退。
本研究发现了潜在的新AE信号，可能为relugolix的临床监测和风险识别提供重要支持。
