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Pharmacokinetic variability of eslicarbazepine in real clinical practice
Epilepsy & Behavior ( IF 2.6 ) Pub Date : 2021-09-11 , DOI: 10.1016/j.yebeh.2021.108284
Maria de Toledo 1 , Laura Valladares-Salado 2 , Jose Cebrian-Escudero 2 , Carolina Diaz-Perez 2 , Elisa de la Fuente 2 , Raquel Ferreiros 3 , Elena Sanz-Sanz 3 , Lorena Vega-Piris 4 , Alfonso Lagares 5 , Maria C Ovejero-Benito 6 , Monica Sobrado 2
Affiliation  

Introduction

Eslicarbazepine acetate (ESL) is a sodium channel blocker indicated for partial-onset seizures with or without secondary generalization, at a single daily dose. There are very few publications on the levels of ESL metabolites in real clinical practice.

Objective

To describe the serum levels of licarbazepine (main metabolite of ESL) in patients with refractory epilepsy in real clinical practice. To evaluate the influence of age, sex, and polytherapy on levels and adverse effects.

Methods

This study involved a retrospective analysis of patients diagnosed with epilepsy treated with ESL for whom plasma levels of licarbazepine were available, measured by spectrophotometry.

Results

Sixty-four patients were included. One patient had licarbazepine levels of 0 (admitted not taking the drug) was not analyzed. Mean licarbazepine levels of 7.66 µg/mL (400 mg/day dose), 16.56 µg/mL (800-mg dose), and 20.80 µg/mL (1200 mg) were significantly different. There was a significant correlation between daily dose and serum levels (p < 0.05) and between the concentration/dose ratio and lower to higher doses (p < 0.05). Pharmacokinetic variability (coefficient of variation for the concentration/dose ratio) was 33.2%. We found a decrease in the concentration/dose ratio in the 1200 mg/day dose, compared to lower doses. We did not find differences by sex or intake of other antiepileptic inducers or metabolic inhibitors. Fifteen patients (23.8%) had mild nonsymptomatic hyponatremia.

Conclusion

These results suggest that it is not necessary to routinely determine licarbazepine levels. In specific cases, licarbazepine levels can be useful to assess adherence to treatment and for personalized dose adjustment.



中文翻译:

实际临床实践中艾司利卡西平的药代动力学变异性

介绍

醋酸艾司利卡西平 (ESL) 是一种钠通道阻滞剂,适用于伴有或不伴有继发性全身性发作的部分性癫痫发作,每日服用一次。关于实际临床实践中 ESL 代谢物水平的出版物很少。

客观的

描述实际临床实践中难治性癫痫患者利卡西平(ESL 的主要代谢产物)的血清水平。评估年龄、性别和综合疗法对水平和不良反应的影响。

方法

该研究涉及对经 ESL 治疗的诊断为癫痫的患者进行回顾性分析,这些患者的血浆利卡西平水平可用分光光度法测量。

结果

包括六十四名患者。一名患者的利卡西平水平为 0(承认未服用药物)未进行分析。7.66 µg/mL(400 毫克/天剂量)、16.56 µg/mL(800 毫克剂量)和 20.80 µg/mL(1200 毫克)的平均利卡西平水平显着不同。日剂量与血清水平之间存在显着相关性 ( p  < 0.05),并且浓度/剂量比与较低至较高剂量之间存在显着相关性( p  < 0.05)。药代动力学变异性(浓度/剂量比的变异系数)为 33.2%。我们发现与较低剂量相比,1200 毫克/天剂量的浓度/剂量比有所降低。我们没有发现性别或其他抗癫痫诱导剂或代谢抑制剂摄入量的差异。15 名患者 (23.8%) 出现轻度无症状低钠血症。

结论

这些结果表明没有必要定期确定利卡西平水平。在特定情况下,利卡西平水平可用于评估治疗依从性和个性化剂量调整。

更新日期:2021-09-12
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