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Therapeutic Drug Monitoring of Lacosamide in Chinese Pediatric Patients with Epilepsy: Efficacy and Factors Influencing the Plasma Concentration

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European Journal of Drug Metabolism and Pharmacokinetics Aims and scope Submit manuscript

Abstract

Background and Objective

The impact of individual patient variables on drug metabolism is particularly important for antiseizure medication, and lacosamide has not been studied in Chinese pediatric patients with epilepsy. This study evaluated the effects of dose, age, sex, medication time, seizure type, and concomitant enzyme-inducing antiseizure medications (EIASMs) on the plasma concentration of lacosamide.

Methods

A total of 500 pediatric patients from two hospitals in China were enrolled in this study. Lacosamide plasma concentration was processed using an ultra-performance liquid chromatography assay. Efficacy was evaluated based on the four-grade therapeutic effect criteria developed by the first National Epilepsy Academic Conference of the Chinese Medical Association.

Results

The responder rate to lacosamide therapy was 72.2% (361/500). There was a weaker relationship between the lacosamide daily dose and lacosamide plasma concentration (r = 0.238). Lacosamide plasma concentrations of patients ranged from 1.5 to 19.7 µg/mL, with a mean of 6.9 ± 3.2 µg/mL. The study results showed a significant contribution of age, body mass index, epilepsy duration, medication time, and EIASMs to the lacosamide plasma concentration (p < 0.05). Patients taking concomitant EIASMs with lacosamide had a significantly lower mean lacosamide plasma concentration (5.9 ± 2.6 µg/mL) than patients taking concomitant non-EIASMs (7.5 ± 3.5 µg/mL, p < 0.001).

Conclusion

To ensure the clinical efficacy and safety of lacosamide therapy in pediatric patients, it is necessary to monitor the plasma concentration.

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Author information

Author notes

  1. Ting Zhao and Hong-jian Li contributed equally to this work and should be considered co-first authors. Correspondence: Yan Sun, Department of Neurology, Xinjiang Hospital of Beijing Children’s Hospital, Children’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China. E-mail: sunkefang@163.com. Lu-hai Yu, Department of Pharmacy, People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang Province 830001, China. E-mail: 1523264450@qq.com.

Authors and Affiliations

  1. Department of Pharmacy, People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi, 830001, Xinjiang, China

    Ting Zhao, Hong-jian Li, Hui-lan Zhang, Jie Feng, Ting-ting Wang & Lu-hai Yu

  2. Institute of Clinical Pharmacy of Xinjiang Uygur Autonomous Region, People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi, 830001, Xinjiang, China

    Ting Zhao, Hong-jian Li, Hui-lan Zhang, Jie Feng, Ting-ting Wang & Lu-hai Yu

  3. Department of Neurology, Children’s Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Hospital of Beijing Children’s Hospital, Urumqi, 830001, Xinjiang, China

    Jing Yu & Yan Sun

Authors
  1. Ting Zhao
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  2. Hong-jian Li
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Corresponding authors

Correspondence to Yan Sun or Lu-hai Yu.

Ethics declarations

Funding

This study was supported by the Scientific Research Fund of Pharmaceutical Society of Xinjiang Uygur Autonomous Region (project approval number: YXH202105).

Conflict of interest

All authors declare that they have no conflict of interests.

Ethical Approval

Approval was obtained from the Ethics Committee of People’s Hospital of Xinjiang Uygur Autonomous Region (Xinjiang, China; Ethical Approval number: KY2019120614).

Consent to Participate

Written informed consent was obtained from each patient or legally authorized representative prior to study enrollment.

Consent for Publication

Not applicable.

Code availability

Not applicable.

Author Contributions

Study design/concept: T.Z., H.-j.L., Y.S., and L.-h.Y. Data acquisition/analysis: all authors. Mentorship and data interpretation: T.Z., H.-j.L., H.-l.Z., J.Y., Y.S. and L.-h.Y. Statistical analysis: T.Z., H.-j.L., and L.-h.Y. Each author contributed important intellectual content during manuscript drafting or revision and accepts accountability for the overall work by ensuring that questions pertaining to the accuracy or integrity of any portion of the work are appropriately investigated and resolved.

Data Availability Statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Zhao, T., Li, Hj., Zhang, Hl. et al. Therapeutic Drug Monitoring of Lacosamide in Chinese Pediatric Patients with Epilepsy: Efficacy and Factors Influencing the Plasma Concentration. Eur J Drug Metab Pharmacokinet 48, 41–49 (2023). https://doi.org/10.1007/s13318-022-00808-2

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