Post-marketing safety concerns with relugolix: a disproportionality analysis of the FDA adverse event reporting system.

IF 3 3区医学 Q2 ONCOLOGY

Investigational New Drugs Pub Date : 2024-10-01 Epub Date: 2024-08-12 DOI:10.1007/s10637-024-01457-9

Chunyong Xia, Zhijing Liu, Jie Liu, Li Lin, Maohua Chen

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引用次数: 0

Abstract

Background: 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).

Methods: 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.

Results: 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.

Conclusion: This study found potential new AEs signals and might provide important support for clinical monitoring and risk identification of relugolix.

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relugolix上市后的安全问题：对FDA不良事件报告系统的比例失调分析。

背景介绍瑞乐戈利一直被用于治疗晚期前列腺癌。本研究从美国食品药品管理局不良事件报告系统（FAERS）中评估了与瑞格列奈相关的不良事件（AEs）：方法：采用包括报告几率比（ROR）、报告比例比（PRR）、贝叶斯置信度传播神经网络（BCPN）和多项目伽马泊松收缩器（MGPS）算法在内的比例失调分析来量化瑞格列奈相关不良事件的信号：结果：FAERS数据库共收集了5,059,213份AEs报告，其中5,662份报告确定瑞格列奈为 "主要疑似药物（PS）"。同时保留了符合四种算法的共 70 个重大不相称性 PT。还可能出现意想不到的新 AE，如勃起功能障碍、妇科肿瘤、睾丸萎缩、男性生殖器萎缩、性欲减退等：本研究发现了潜在的新 AEs 信号，可为瑞格列奈的临床监测和风险识别提供重要支持。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Investigational New Drugs 医学-药学

CiteScore

7.60

自引率

0.00%

发文量

121

审稿时长

1 months

期刊介绍： The development of new anticancer agents is one of the most rapidly changing aspects of cancer research. Investigational New Drugs provides a forum for the rapid dissemination of information on new anticancer agents. The papers published are of interest to the medical chemist, toxicologist, pharmacist, pharmacologist, biostatistician and clinical oncologist. Investigational New Drugs provides the fastest possible publication of new discoveries and results for the whole community of scientists developing anticancer agents.