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<p>Personalized precision dosing remains an unmet clinical need. This study used population pharmacokinetic (PopPK) modeling to evaluate transitioning lacosamide (LCM) in children with epilepsy from body weight (BW)-based (mg/kg) to simplified BW-band or fixed-dose (mg) regimens. Real-world data from 190 patients were analyzed using nonlinear mixed-effects modeling program, comparing a BW-based model (Model I) and a genotype-guided model (Model II); the latter showed superior predictive performance. Monte Carlo simulations confirmed comparable LCM exposure across regimens, with &gt;78% target attainment in external validation. A fixed 100 mg dose for patients ≥10 kg achieved equivalent exposure to BW-adjusted dosing, with consistent results in 1–4 years and obese patients. These findings enabled BW-band dosing as a clinically viable alternative to mg/kg regimens, while <i>CYP2C19</i> genotyping further enhanced precision. This PopPK-based strategy simplifies LCM therapy without compromising efficacy, offering a practical approach to personalized epilepsy management in children.</p><p></p>

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PopPK modeling supports BW band dosing of lacosamide for pediatric epilepsy

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年8月28日

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  • Yue Li,
  • Hong-Li Guo,
  • Lin Fan,
  • Jie Wang,
  • Ya-Hui Hu,
  • Yuan-Yuan Zhang,
  • Jin-Chun Qiu,
  • Jing Chen,
  • Chun-Feng Wu,
  • Gang Zhang,
  • Xiao-Peng Lu,
  • Feng Chen

摘要

Personalized precision dosing remains an unmet clinical need. This study used population pharmacokinetic (PopPK) modeling to evaluate transitioning lacosamide (LCM) in children with epilepsy from body weight (BW)-based (mg/kg) to simplified BW-band or fixed-dose (mg) regimens. Real-world data from 190 patients were analyzed using nonlinear mixed-effects modeling program, comparing a BW-based model (Model I) and a genotype-guided model (Model II); the latter showed superior predictive performance. Monte Carlo simulations confirmed comparable LCM exposure across regimens, with >78% target attainment in external validation. A fixed 100 mg dose for patients ≥10 kg achieved equivalent exposure to BW-adjusted dosing, with consistent results in 1–4 years and obese patients. These findings enabled BW-band dosing as a clinically viable alternative to mg/kg regimens, while CYP2C19 genotyping further enhanced precision. This PopPK-based strategy simplifies LCM therapy without compromising efficacy, offering a practical approach to personalized epilepsy management in children.