title: Vigabatrin pediatric dosing information for refractory complex partial seizures: results from a population dose-response analysis.
abstract: 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 1 g/day adult dosage were 350 and 450 mg/day for patients with body weight ranges 10-15 and >15-20 kg, respectively. Predicted oral solution dosages for efficacy comparable to a 3 g/day adult dosage were 1,050 and 1,300 mg/day for weight ranges 10-15 and >15-20 kg, respectively. Predicted tablet dosage for efficacy comparable to a 1 g/day adult dosage was 500 mg/day for weight ranges 25-60 kg. Predicted tablet dosage for efficacy comparable to a 3 g/day adult dosage was 2,000 mg for weight ranges 25-60 kg. Vigabatrin dosages were identified for pediatric rCPS patients with body weights ≥10 kg.
authors.affiliation: Ann Arbor Pharmacometrics Group, Ann Arbor, Michigan, U.S.A.
authors.forename: Jace C
authors.initials: JC
authors.lastname: Nielsen
authors.forename: Dwain
authors.initials: D
authors.lastname: Tolbert
authors.forename: Mahlaqa
authors.initials: M
authors.lastname: Patel
authors.forename: Kenneth G
authors.initials: KG
authors.lastname: Kowalski
authors.forename: David L
authors.initials: DL
authors.lastname: Wesche
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D001835:Body Weight; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D018672:Community Health Planning; D004305:Dose-Response Relationship, Drug; D017029:Epilepsy, Complex Partial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010372:Pediatrics; D020888:Vigabatrin / Q000627:therapeutic use*
chemical_list: D000927:Anticonvulsants; D020888:Vigabatrin
keywords: Dosage prediction; Epilepsy; Infantile spasm; Refractory complex partial seizures; Vigabatrin