Abstracts

Double-blind, randomized controlled trials of topiramate included children [ge]6 yrs of age, although most pediatric patients were adolescents. Patients were randomized to 50, 100, 200, 400, or 500 mg/day. Although these studies identified 100 mg/day as an effective, initial target dose, they were not designed to identify a maintenance dose. This open-label study allowed topiramate dosages to be adjusted according to clinical response in order to determine an optimal maintenance dose. We report on findings from the subset of children with newly/recently diagnosed epilepsy enrolled in this in-practice study. An open-label, multicenter prospective study conducted in Europe and the Middle East followed children and adults treated with topiramate monotherapy for 7-13 mos. Children 2-16 yrs old were eligible if epilepsy was diagnosed [lt]5 yrs previously and they were treatment-naive or had failed one antiepileptic drug. All epilepsy types were eligible. Study procedures allowed flexible topiramate dosing. Initial target dose: adolescents (13-16 yrs), 100 mg/day; younger children (2-12 yrs), 3 mg/kg/day. Of 690 patients with evaluable data, 66 were adolescents; 122 were children. 70% had focal epilepsy; 58% were treatment-naive. Most common reason for failing previous treatment was ineffectiveness. Mean topiramate maintenance dose at 7 mos: adolescents, 156 mg/day; younger children, 3.9 mg/kg/day. Seizure-free rates ([ge]7 mos): overall, 44%; treatment-na[iuml]ve, 54%; previously treated, 37%. Most common ([ge]5% incidence) treatment-emergent events (other than childhood-related illnesses) were headache and appetite decrease in younger children and adolescents; somnolence, paresthesia, weight loss and dizziness in adolescents. 21% of patients discontinued: side effects, 2%; side effects and inadequate seizure control, 6%; inadequate seizure control, 11%; other reasons (eg, lost to follow-up), 6%. Topiramate monotherapy appears to be effective and well-tolerated in adolescents and children with newly/recently diagnosed focal and generalized epilepsy. From these data, recommended initial target dose: adolescents, 100 mg/day; younger children, 3 mg/kg/day. (Supported by Janssen-Cilag)