Drug-induced liver injury associated with the use of newer antiseizure medications in the elderly: an analysis of data from VigiBase.

IF 3.9 3区医学 Q2 BIOCHEMISTRY & MOLECULAR BIOLOGY

Expert Opinion on Drug Metabolism & Toxicology Pub Date : 2023-03-01 DOI:10.1080/17425255.2023.2203859

Sanja Petrović, Milena Kovačević, Sandra Vezmar Kovačević, Branislava Miljkovic

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引用次数: 0

Abstract

Background: Data on drug-induced liver injury (DILI) caused by newer antiseizure medications (ASMs) in the elderly are scarce and mainly come from literature case reports. We analyzed Individual Case Safety Reports (ICSRs) of DILI in elderly patients treated with newer ASMs reported to VigiBase.

Research design and methods: Empirica™ Signal software was used to retrieve ICSRs reported to VigiBase up to 31 December 2021 and to calculate Empirical Bayesian Geometric Mean and corresponding 90% confidence intervals (EB05, EB95) for each drug-event pair. EB05 > 2, N > 0 was considered a signal. Analysis by age subgroups and gender was performed to assess the influence of these factors on ICSR characteristics and identified signals.

Results: There were 1399 ICSRs reporting 1947 events of hepatotoxicity. 56.97% of the reports were reported in females, 67.05% were serious, and 3.36% resulted in death. For one or more events of hepatotoxicity, signals were detected for lamotrigine, levetiracetam, oxcarbazepine, topiramate, and zonisamide. Age- and gender-biased reporting frequency was identified for topiramate-induced hyperammonemia, with disproportionally higher reporting frequency in ≥75-year-old male patients.

Conclusions: The results of our study indicate differences among newer ASMs in their potential to cause DILI in the elderly. Further studies are needed to confirm the associations identified in this study.

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药物性肝损伤与老年人使用新型抗癫痫药物相关:VigiBase数据分析

背景:关于老年人新型抗癫痫药物(asm)引起的药物性肝损伤(DILI)的数据很少，主要来自文献病例报道。我们分析了VigiBase报告的接受较新asm治疗的老年患者DILI的个案安全报告(ICSRs)。研究设计和方法:使用Empirica™Signal软件检索截至2021年12月31日报告给VigiBase的icsr，并计算每个药物事件对的Empirical Bayesian Geometric Mean和相应的90%置信区间(EB05, EB95)。认为EB05 > 2, N > 0为信号。按年龄亚组和性别进行分析，以评估这些因素对ICSR特征和已识别信号的影响。结果:1399份icrs报告了1947例肝毒性事件。其中女性占56.97%，重症占67.05%，死亡占3.36%。对于一个或多个肝毒性事件，检测了拉莫三嗪、左乙拉西坦、奥卡西平、托吡酯和唑尼沙胺的信号。托吡酯引起的高氨血症的报告频率存在年龄和性别偏见，≥75岁男性患者的报告频率不成比例地更高。结论:我们的研究结果表明，新发asm在引起老年人DILI的可能性方面存在差异。需要进一步的研究来证实本研究中发现的关联。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Drug Metabolism & Toxicology 医学-生化与分子生物学

CiteScore

7.90

自引率

2.30%

发文量

审稿时长

4-8 weeks

期刊介绍： Expert Opinion on Drug Metabolism & Toxicology (ISSN 1742-5255 [print], 1744-7607 [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of ADME-Tox. Each article is structured to incorporate the author’s own expert opinion on the scope for future development. The Editors welcome: Reviews covering metabolic, pharmacokinetic and toxicological issues relating to specific drugs, drug-drug interactions, drug classes or their use in specific populations; issues relating to enzymes involved in the metabolism, disposition and excretion of drugs; techniques involved in the study of drug metabolism and toxicology; novel technologies for obtaining ADME-Tox data. Drug Evaluations reviewing the clinical, toxicological and pharmacokinetic data on a particular drug. The audience consists of scientists and managers in the pharmaceutical industry, pharmacologists, clinical toxicologists and related professionals.