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.

受试者人口学信息
研究概况
本研究为一项多中心、前瞻性、开放标签的抗癫痫药物药代动力学（pharmacokinetic，PK）与安全性研究，纳入年龄为2岁至18岁以下的肥胖儿童受试者，所有受试者均按照主管医师开具的标准治疗（standard of care，SOC）方案接受药物治疗。
本研究纳入多款目标研究药物，其中包括托吡酯。采用当前推荐给药方案的模拟结果显示，在各主要儿童年龄亚组中，合并肥胖与未合并肥胖的儿童受试者的托吡酯稳态谷浓度无显著差异。因此，托吡酯当前推荐给药方案可通用适用于所有儿童，无需考虑其肥胖状态。
本标准治疗研究中，托吡酯组受试者未报告任何不良事件（Adverse Events，AE），未发现安全性相关问题。纳入安全性分析人群的受试者均接受了托吡酯治疗。