Vigabatrin pediatric dosing information for refractory complex partial seizures: Results from a population dose-response analysis

被引：1

作者：

Nielsen, Jace C. ^{[1
]}

Tolbert, Dwain ^{[2
]}

Patel, Mahlaqa ^{[2
]}

Kowalski, Kenneth G. ^{[1
]}

Wesche, David L. ^{[2
]}

机构：

[1] Ann Arbor Pharmacometr Grp Inc, Ann Arbor, MI 48104 USA

[2] Lundbeck LLC, Deerfield, IL USA

来源：

EPILEPSIA | 2014年 / 55卷 / 12期

关键词：

Vigabatrin; Dosage prediction; Epilepsy; Infantile spasm; Refractory complex partial seizures; LABELING DECISIONS; DRUG APPROVAL; EPILEPSY; CHILDREN; THERAPY; IMPACT; RISK;

D O I：

10.1111/epi.12825

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

We predicted vigabatrin dosages for adjunctive therapy for pediatric patients with refractory complex partial seizures (rCPS) that would produce efficacy comparable to that observed for approved adult dosages. A dose-response model related seizure-count data to vigabatrin dosage to identify dosages for pediatric rCPS patients. Seizure-count data were obtained from three pediatric and two adult rCPS clinical trials. Dosages were predicted for oral solution and tablet formulations. Predicted oral solution dosages to achieve efficacy comparable to that of a 1g/day adult dosage were 350 and 450mg/day for patients with body weight ranges 10-15 and >15-20kg, respectively. Predicted oral solution dosages for efficacy comparable to a 3g/day adult dosage were 1,050 and 1,300mg/day for weight ranges 10-15 and >15-20kg, respectively. Predicted tablet dosage for efficacy comparable to a 1g/day adult dosage was 500mg/day for weight ranges 25-60kg. Predicted tablet dosage for efficacy comparable to a 3g/day adult dosage was 2,000mg for weight ranges 25-60kg. Vigabatrin dosages were identified for pediatric rCPS patients with body weights 10kg.

引用

页码：e134 / e138

页数：5