Adverse events related to abiraterone and enzalutamide treatment: analysis of the EudraVigilance database and meta-analysis of registrational phase III studies.
Adverse events related to abiraterone and enzalutamide treatment: analysis of the EudraVigilance database and meta-analysis of registrational phase III studies.
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DOI：
10.1038/s41391-019-0182-x
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发表时间：
2020-06-01
影响因子：
4.8
通讯作者：
Tubaro, Andrea
中科院分区：
文献类型：
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作者：
De Nunzio, Cosimo;Lombardo, Riccardo;Tubaro, Andrea
背景：临床试验的数据并不总是提供足够的信息来判断在现实世界中使用的新疗法的影响。本研究的目的是使用EudraVigilance(EV)数据库中的真实数据分析与苯扎鲁胺(ENZ)和阿比特龙(ABI)相关的不良事件(AEs)。方法：EV数据库是管理和分析欧洲经济区已批准或正在进行临床试验的可疑药物不良反应信息的系统。我们记录了2013年1月至2019年1月每个类别和严重程度的ABI和ENZ的不良事件数量。此外，我们还记录了每个年龄组的不良反应。结果：在EV数据库中确定的个体病例数量ABI为13,562例，ENZ为40,599例。超过90%的报告不良反应被定义为两种药物的严重不良反应。与年轻患者相比，接受ABI或ENZ治疗的老年患者(85岁和65-85岁)患心脏、感染、代谢和呼吸系统疾病的风险更高。
BACKGROUND: Data from clinical trials do not always provide adequate information to judge the impact of new treatments when used in a real-world setting. The aim of our study was to analyze adverse events (AEs) associated with enzalutamide (ENZ) and abiraterone (ABI) using real-life data from the EudraVigilance (EV) database.METHODS: The EV database is the system for managing and analyzing information on suspected adverse reactions to medicines, which have been authorized or are being studied in clinical trials in the European Economic Area. We recorded the number of AEs for ABI and ENZ per category and severity from January 2013 to January 2019. In addition, we recorded AEs per age group. A meta-analysis of AEs reported in registrational phase III studies (AFFIRM, PREVAIL, COU-AA) was performed.RESULTS: The number of individual cases identified in EV database was 13,562 for ABI and 40,599 for ENZ. Over 90% of the reported AEs were defined as serious for both drugs. Older patients (>85 years and 65-85 years) treated with ABI or ENZ are at increased risk of cardiac, infectious, metabolic, and respiratory disorders when compared with younger patients (