Safety study on adverse events of zanubrutinib based on WHO-VigiAccess and FAERS databases.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-15 DOI:10.1080/14740338.2024.2416917
Qiaofang Liang, Xiaolin Liao, Yushen Huang, Jiang Zeng, Cong Liang, Ying He, Hongwen Wu
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Abstract

Objective: The study endeavors to elucidate AE signals associated with zanubrutinib data from the WHO-VigiAccess and FAERS databases. The aim is to furnish robust scientific evidence to inform clinical practice and regulatory decisions.

Methods: We meticulously extracted all AE breports tied to zanubrutinib from the both databases, encompassing the period from the drug's market introduction until 30 April 2024. Retrospective quantitative analysis employing ROR, PRR, and BCPNN methodologies were utilized to analysis.

Results: The investigation unveiled 1,304 reports from WHO-VigiAccess and 1,141 reports from FAERS related to zanubrutinib. Among the top 30 reported PTs in both databases, those not recorded in the drug label included pyrexia, dizziness, and death. In the FAERS database, signals for zanubrutinib were detected across 19 SOCs. Systems not covered in the drug label included reproductive system and breast disorders, metabolism and nutrition disorders, ear and labyrinth disorders, among others. Unmentioned signals included intestinal perforation, onychoclasis, night sweats, etc.

Conclusion: This study confirms common AEs of zanubrutinib and identifies new ones, highlighting the need for careful monitoring and personalized treatment. It also emphasizes the importance of ongoing drug safety surveillance and patient management to maximize therapeutic benefits and minimize risks.

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基于 WHO-VigiAccess 和 FAERS 数据库的扎鲁替尼不良事件安全性研究。
研究目的本研究旨在阐明与WHO-VigiAccess和FAERS数据库中扎鲁替尼数据相关的AE信号。目的是为临床实践和监管决策提供可靠的科学证据:我们从这两个数据库中精心提取了与扎鲁替尼相关的所有AE breports,时间跨度为该药物上市至2024年4月30日。采用ROR、PRR和BCPNN方法进行回顾性定量分析:调查发现,WHO-VigiAccess 和 FAERS 分别提供了 1,304 份和 1,141 份与扎鲁替尼有关的报告。在这两个数据库中报告的前 30 种 PTs 中,未在药物标签中记录的包括热病、头晕和死亡。在FAERS数据库中,19个SOC中都检测到了扎鲁替尼的信号。药物标签中未涉及的系统包括生殖系统和乳腺疾病、新陈代谢和营养失调、耳部和迷宫疾病等。未提及的信号包括肠穿孔、甲癣、盗汗等:本研究证实了扎鲁替尼的常见AEs,并发现了新的AEs,强调了仔细监测和个性化治疗的必要性。它还强调了持续的药物安全性监测和患者管理对于最大限度地提高治疗效果和降低风险的重要性。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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