Ge Chang, Jin Liuyin, Tian Jing-Jing, Yang Na, Xu Jian
Department of Obstetrics and Gynecology, Fourth Affiliated Hospital, Zhejiang University School of Medicine, Yiwu, China.
Lishui Second People's Hospital, Zhejiang, China.
Front Pharmacol. 2024 Sep 19;15:1418609. doi: 10.3389/fphar.2024.1418609. eCollection 2024.
Epilepsy is a chronic neurological condition requiring effective management with minimal adverse effects. Lacosamide (LCM) and Perampanel (PER), two promising treatments, have distinct profiles that merit comparative analysis to guide clinical decision-making.
This study utilizes a pharmacovigilance analysis of adverse events reported in the FDA Adverse Event Reporting System database from Q1 2009 to Q3 2023. Employing disproportionality and Bayesian analyses, we assessed and compared the AE signals associated with LCM and PER to elucidate their safety profiles in epilepsy treatment.
The analysis included 12,576 AE reports for LCM and 2,703 for PER, highlighting a higher incidence of psychiatric disorders, including aggression with LCM, and a notable association of PER with psychiatric disorders such as psychotic disorders and dizziness. LCM showed a relatively safe profile during pregnancy, whereas PER's data suggested caution due to reported cases of suicidal ideation and attempts.
This comprehensive evaluation underscores the importance of understanding the distinct AE profiles of LCM and PER in clinical practice, providing valuable insights for personalized epilepsy management. Future research with rigorous prospective designs is recommended to validate these findings and explore the mechanisms underlying the reported adverse events.
癫痫是一种慢性神经系统疾病，需要进行有效管理且副作用最小。拉科酰胺（LCM）和吡仑帕奈（PER）是两种有前景的治疗方法，它们具有不同的特征，值得进行比较分析以指导临床决策。
本研究利用对2009年第一季度至2023年第三季度美国食品药品监督管理局不良事件报告系统数据库中报告的不良事件进行药物警戒分析。采用不成比例分析和贝叶斯分析，我们评估并比较了与LCM和PER相关的不良事件信号，以阐明它们在癫痫治疗中的安全性概况。
分析包括12576份LCM的不良事件报告和2703份PER的不良事件报告，突出显示了精神障碍的较高发生率，包括LCM导致的攻击行为，以及PER与精神障碍如精神疾病和头晕的显著关联。LCM在孕期显示出相对安全的概况，而PER的数据因有自杀意念和自杀未遂的报告病例而提示需谨慎使用。
这项全面评估强调了在临床实践中了解LCM和PER不同不良事件概况的重要性，为个性化癫痫管理提供了有价值的见解。建议未来进行严格前瞻性设计的研究以验证这些发现，并探索所报告不良事件的潜在机制。
