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.

journal_name

Epilepsia

journal_title

Epilepsia

authors

Nielsen JC,Tolbert D,Patel M,Kowalski KG,Wesche DL

doi

10.1111/epi.12825

subject

Has Abstract

pub_date

2014-12-01 00:00:00

pages

e134-8

issue

12

eissn

0013-9580

issn

1528-1167

journal_volume

55

pub_type

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