Demographics in Pharmacokinetics of Anti-epileptic Drugs in Obese Children - Topiramate

Participant Demographic Information
Study Description
This was a multi-center, prospective, open-label, pharmacokinetic (PK) and safety study of anti-epileptic drugs in obese children age 2 to less than 18 years of age who received drugs per standard of care (SOC), as prescribed by a treating clinician. Participants were enrolled under multiple drugs of interest, including topiramate. Simulation results (with the currently recommended dosing regimens) did not reveal any meaningful difference in the steady-state topiramate trough concentrations between the subgroups of children with and without obesity, across the major pediatric age groups. Therefore, the currently recommended dosing regimen of topiramate can be universally applied to children, irrespective of their obesity status. No AEs were reported in topiramate participants, and no safety concerns were identified in this SOC study. Participants who received topiramate and were included in the safety population.

受试者人口统计学资料

## 研究概况
本研究为一项多中心、前瞻性、开放标签的药代动力学（pharmacokinetic, PK）与安全性研究，针对2岁至18岁以下的肥胖儿童群体，受试者按照主管医师开具的标准治疗方案（standard of care, SOC）接受抗癫痫药物治疗。本研究纳入了多种目标研究药物的受试者，其中包括托吡酯（topiramate）。基于当前推荐给药方案的模拟结果显示，在主要儿科年龄分层中，合并肥胖与未合并肥胖的儿童亚组之间，托吡酯稳态谷浓度无显著临床差异。因此，无论受试者的肥胖状态如何，当前推荐的托吡酯给药方案均可普遍适用于儿童群体。本标准治疗方案研究中，接受托吡酯治疗的受试者未报告任何不良反应（adverse events, AEs），亦未发现任何安全性隐患。纳入安全性分析人群的受试者均接受了托吡酯治疗。