Clinical impact of therapeutic drug monitoring for newer anti-seizure medications in patients with epilepsy: A real-world observation study

IF 4.1 3区 医学 Q2 BIOCHEMISTRY & MOLECULAR BIOLOGY Biomedical Journal Pub Date : 2023-11-29 DOI:10.1016/j.bj.2023.100680
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Abstract

Background

The clinical value of therapeutic drug monitoring (TDM) for newer anti-seizure medications (ASMs) remains uncertain. This study aimed to assess the impact of newer ASM TDM on clinical decision making in patients with epilepsy.

Methods

We retrospectively identified all plasma requests for newer ASM level measurement as part of routine clinical management in the outpatient departments of seven medical institutes across Taiwan between September 2016 and May 2019. Data collected from reviewed medical records included clinical and medication details, indications for TDM requests, test results, interpretation, and impact on patient management.

Results

A total of 682 visits with 1051 plasma samples were included. The most frequently analyzed ASMs were levetiracetam (36.1%), oxcarbazepine (18.4%), and lamotrigine (12.0%). Reasons for TDM included poorly controlled seizures (55.3%), concerns about drug-drug interactions (12.3%), and suspicion of drug overdose (10.6%). 68.8% of samples were within the orienting therapeutic range, even for patients with poorly controlled seizures. TDM for non-adherence concerns showed 54.3% below the orienting therapeutic range, while ASM-related adverse events assessment only 8.9% showed levels exceeding the orienting therapeutic range. Following TDM results, 64.2% of cases had medication adjustments, mainly dosage increases. Overall, 55.9% of newer ASM TDM visits showed improved outcomes, including reduced seizures (47.5%) and fewer ASM-related side effects (8.4%).

Conclusions

These findings suggest that appropriate utilization of TDM for newer ASMs provides clinical benefits in adjunct to complement clinical decision making in the management of epilepsy patients in a real-world clinical setting.

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治疗药物监测对癫痫患者新型抗癫痫药物的临床影响:一项真实世界的观察研究。
背景:治疗性药物监测(TDM)对新型抗癫痫药物(asm)的临床价值尚不确定。本研究旨在评估新ASM TDM对癫痫患者临床决策的影响。方法:我们回顾性分析了2016年9月至2019年5月台湾7家医疗机构门诊常规临床管理的所有血浆更新ASM水平测量要求。从审查的医疗记录中收集的数据包括临床和药物详细信息、TDM请求的适应症、测试结果、解释以及对患者管理的影响。结果:共就诊682次,血浆样本1051份。最常见的是左乙拉西坦(36.1%)、奥卡西平(18.4%)和拉莫三嗪(12.0%)。发生TDM的原因包括癫痫发作控制不佳(55.3%)、担心药物相互作用(12.3%)和怀疑药物过量(10.6%)。68.8%的样本在定向治疗范围内,即使对癫痫控制不佳的患者也是如此。TDM对不依从性的关注显示54.3%低于定向治疗范围,而asm相关不良事件评估显示只有8.9%的水平超过定向治疗范围。TDM结果后,64.2%的病例进行了用药调整,以剂量增加为主。总体而言,55.9%的新ASM TDM患者表现出改善的结果,包括癫痫发作减少(47.5%)和ASM相关副作用减少(8.4%)。结论:这些研究结果表明,在现实世界的临床环境中,适当使用TDM治疗新发asm可以辅助补充癫痫患者管理的临床决策。
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来源期刊
Biomedical Journal
Biomedical Journal Medicine-General Medicine
CiteScore
11.60
自引率
1.80%
发文量
128
审稿时长
42 days
期刊介绍: Biomedical Journal publishes 6 peer-reviewed issues per year in all fields of clinical and biomedical sciences for an internationally diverse authorship. Unlike most open access journals, which are free to readers but not authors, Biomedical Journal does not charge for subscription, submission, processing or publication of manuscripts, nor for color reproduction of photographs. Clinical studies, accounts of clinical trials, biomarker studies, and characterization of human pathogens are within the scope of the journal, as well as basic studies in model species such as Escherichia coli, Caenorhabditis elegans, Drosophila melanogaster, and Mus musculus revealing the function of molecules, cells, and tissues relevant for human health. However, articles on other species can be published if they contribute to our understanding of basic mechanisms of biology. A highly-cited international editorial board assures timely publication of manuscripts. Reviews on recent progress in biomedical sciences are commissioned by the editors.
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