Fan Yunhe, Wu Teng, Xu Pengyang, Yang Chuanli, An Jie, Zhang Haijia, Abbas Mureed, Dong Xiushan
Department of General Surgery, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Third Hospital of Shanxi Medical University, Tongji Shanxi Hospital, Taiyuan, China.
Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan, China.
Front Pharmacol. 2024 Sep 13;15:1425171. doi: 10.3389/fphar.2024.1425171. eCollection 2024.
Neratinib has emerged as significant theraputic option for breast cancer treatment. However, despite its approval, numerous adverse drug events (ADEs) associated to it remain unrecognized and unreported. This study aims to mine and analyze the signals of ADEs related to neratinib from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, providing insights for safe and rational clinical use of drug.
All the neratinib-related ADEs data were collected from FAERS database from the third quarter (Q3) of 2017 to the fourth quarter (Q4) of 2023. After standardizing the data, 4 disproportionality methods were used to assess the correlation between neratinib and ADEs.
Of the 1,544 ADEs implicating neratinib as the primary suspected drug, a combined total of 48 preferred terms (PTs) and 10 system organ classes (SOCs) showed significant disproportionality accross all four algorithms simultaneously. These SOCs included gastrointestinal disorders (n = 2,564, ROR 7.14), general disorders and administration site conditions (n = 958, ROR 0.77) and injury poisoning and procedural complications (n = 474, ROR 0.58) among others. Upon comparison with the neratinib manual, 34 ADEs not documented in the manual were found at the PT level.
Our study provide new real-world evidence for drug safety information of neratinib. While the majority of our findings were aligned with the information provided in the manual. We identified additional ADEs not previously documented. Consequently, further studies are needed to validate unreported ADEs to ensure the efficacy and safety of neratinib for patients.
奈拉替尼已成为乳腺癌治疗的重要治疗选择。然而，尽管它已获批，但与之相关的众多药物不良事件（ADEs）仍未被识别和报告。本研究旨在从美国食品药品监督管理局不良事件报告系统（FAERS）数据库中挖掘和分析与奈拉替尼相关的ADEs信号，为药物的安全合理临床应用提供见解。
收集2017年第三季度（Q3）至2023年第四季度（Q4）FAERS数据库中所有与奈拉替尼相关的ADEs数据。在对数据进行标准化处理后，使用4种不成比例性方法评估奈拉替尼与ADEs之间的相关性。
在1544例将奈拉替尼列为主要可疑药物的ADEs中，共有48个首选术语（PTs）和10个系统器官类别（SOCs）在所有四种算法中同时显示出显著的不成比例性。这些SOCs包括胃肠道疾病（n = 2564，报告比值比7.14）、全身疾病及给药部位情况（n = 958，报告比值比0.77）以及损伤、中毒和操作并发症（n = 474，报告比值比0.58）等。与奈拉替尼说明书相比，在PT水平发现了34例说明书中未记录的ADEs。
我们的研究为奈拉替尼的药物安全信息提供了新的真实世界证据。虽然我们的大多数发现与说明书中提供的信息一致，但我们识别出了之前未记录的其他ADEs。因此，需要进一步研究来验证未报告的ADEs以确保奈拉替尼对患者的有效性和安全性。
