Concomitant Medications in Pharmacokinetics of Anti-epileptic Drugs in Obese Children - Levetiracetam

Concomitant Medications 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, as prescribed by a treating clinician. Participants were enrolled under multiple drugs of interest, including levetiracetam. The PK of levetiracetam in children was well characterized with a 1-compartment population PK model. After accounting for size-based differences using fat free mass, estimated glomerular filtration rate was associated with clearance of levetiracetam. A weight-based dosing regimen was recommended for levetiracetam oral solution dosing in 2 to <4 years. Weight-tiered dosing regimens were recommended for levetiracetam oral solution dosing and tablet dosing in obese participants 4 to <16 years. Levetiracetam was well tolerated in the study participants. Participants who received levetiracetam and were included in the safety population.

合并用药信息
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）及安全性研究，针对按主治临床医师制定的标准治疗方案接受抗癫痫药物治疗的2至不足18岁肥胖儿童开展。本研究纳入的受试者涉及多种目标研究药物，其中包括左乙拉西坦（levetiracetam）。儿童群体中左乙拉西坦的药代动力学特征已通过一室群体药代动力学模型得到充分表征。在通过去脂体重校正体表面积相关差异后，估算肾小球滤过率与左乙拉西坦的清除率存在相关性。针对2至<4岁的肥胖儿童，推荐采用基于体重的左乙拉西坦口服溶液给药方案。针对4至<16岁的肥胖受试者，左乙拉西坦口服溶液及片剂均推荐采用体重分层给药方案。本研究受试者对左乙拉西坦耐受性良好。接受左乙拉西坦治疗并被纳入安全性分析人群的受试者。