Huang Youqi, Gao Hongjin, Lin Yuze, Chen Xiaowen, Chen Mingyu, Chen Min
Department of Pharmacy, Fujian Provincial Hospital, Shengli Clinical College of Fujian Medical University, Fuzhou, China.
School of Pharmacy, Fujian Medical University, Fuzhou, China.
Expert Opin Drug Saf. 2024 Oct 9:1-8. doi: 10.1080/14740338.2024.2412218.
This study analyzed the signal mining of adverse events caused by finerenone based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) and evaluated the drug's safety to provide a reference for the safe administration of this medication in medical institutions.
FAERS data from the third quarter of 2021 to the fourth quarter of 2023 were used, and the adverse event codes of the Medical Dictionary for Regulatory Activities were compared. After the data were processed, adverse event reports that featured finerenone as the most suspected drug were extracted.
A total of 905 reported cases of adverse events including finerenone as the first suspected drug were extracted. The ratio of male to female patients was 1.25, and most were aged 65-85 years (30.1%). The adverse events that were reported more frequently with positive signals were decreased glomerular filtration rate, hyperkalemia, increased blood creatinine, and dizziness. The adverse events that were concentrated on in investigations were metabolism and nutrition disorders and diseases of the renal and urinary system.
Our study identified significant novel adverse events (AEs) signals for finerenone that could provide support for clinical monitoring of and risk identification for finerenone.
本研究基于美国食品药品监督管理局不良事件报告系统（FAERS）对非奈利酮所致不良事件进行信号挖掘，并评估该药物的安全性，为医疗机构安全使用该药物提供参考。
使用2021年第三季度至2023年第四季度的FAERS数据，比较《监管活动医学词典》的不良事件编码。数据处理后，提取以非奈利酮为最可疑药物的不良事件报告。
共提取905例以非奈利酮为首要可疑药物的不良事件报告病例。男女患者比例为1.25，大多数患者年龄在65 - 85岁（30.1%）。信号为阳性的报告频率较高的不良事件有肾小球滤过率降低、高钾血症、血肌酐升高和头晕。调查集中关注的不良事件为代谢和营养紊乱以及肾脏和泌尿系统疾病。
我们的研究确定了非奈利酮显著的新不良事件信号，可为非奈利酮的临床监测和风险识别提供支持。
