左乙拉西坦相关横纹肌溶解症的真实世界分析:美国食品药品管理局不良事件报告系统的启示。

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Guo Yinan, Gong Guangming, Guo Guangyu, Cheng Xianghai, Yin Jingwen, Qin Jie
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引用次数: 0

摘要

背景:左乙拉西坦是一种广泛处方的抗癫痫药物,因其广谱的疗效、良好的耐受性和极少的药物相互作用而广受认可。本研究利用FDA不良事件报告系统(FAERS)数据库中的真实数据,探讨了左乙拉西坦与横纹肌溶解症之间的关联,以进一步阐明其安全性:本研究从FAERS数据库(2013年第一季度至2024年第一季度)中提取了与左乙拉西坦相关的不良事件。四种比例失调分析确定横纹肌溶解症是一种重要的不良事件。逻辑回归评估了风险因素,包括性别、年龄和严重程度。高斯混合模型分析了横纹肌溶解症的发病时间分布,同时使用报告比值比(ROR)评估了伴随用药对其风险的影响:结果:左乙拉西坦显著增加横纹肌溶解风险(ROR = 13.5)。男性发病率更高(OR = 2.60)。大多数不良事件发生在最初的30天内,呈双峰分布。同时服用抗生素、抗精神病药和PPIs会增加风险,而其他抗癫痫药物则不会:本研究发现,左乙拉西坦与横纹肌溶解症的风险有明显关联,这突出表明临床上需要对这一患者群体提高警惕。未来的研究应侧重于阐明潜在机制和优化临床指南。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-world analysis of levetiracetam-associated rhabdomyolysis: insights from the FDA adverse event reporting system.

Background: Levetiracetam, a widely prescribed antiseizure medication, is recognized for its broad-spectrum efficacy, good tolerability, and minimal drug interactions. This study examines the association between levetiracetam and rhabdomyolysis, utilizing real-world data from the FDA Adverse Event Reporting System (FAERS) database to further elucidate its safety profile.

Methods: This study extracted adverse events related to levetiracetam from the FAERS database (Q1 2013 to Q1 2024). Four types of disproportionality analysis identified rhabdomyolysis as a significant adverse event. Logistic regression assessed risk factors, including gender, age, and severity. A Gaussian Mixture Model analyzed the time-to-onset distribution of rhabdomyolysis, while the impact of concomitant medications on its risk was evaluated using Reporting Odds Ratio (ROR).

Results: Levetiracetam significantly increased rhabdomyolysis risk (ROR = 13.5). Males showed a higher incidence (OR = 2.60). Most adverse events occurred within the first 30 days, with a bimodal onset distribution. Co-administration of antibiotics, antipsychotics, and PPIs elevated the risk while other antiseizure medications did not.

Conclusion: This study found a significant association between levetiracetam and the risk of rhabdomyolysis, highlighting the need for increased clinical vigilance in this patient population. Future research should focus on elucidating the underlying mechanisms and optimizing clinical guidelines.

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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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