Abstracts

RATIONALE: Children and adolescents with epilepsy have not been extensively studied in double-blind randomized controlled trials for new antiepileptic drugs (AEDs). Therefore, important data for daily practice are lacking. The objective of this observational study was to evaluate the efficacy and tolerability of topiramate (TPM) in children and adolescents allowing flexible dosing.
METHODS: In this prospective multicenter open-label observational study patients [lte]16 years of age with a diagnosis of epilepsy were evaluated at baseline and 4, 8, 12 and 26 weeks thereafter. Doses of TPM and concomitant AEDs could be adjusted according to patient response. Seizure frequency and adverse events (AEs) were assessed at every visit. A total of 90 patients (51% male, mean age 8.4 years, mean duration of epilepsy 5.4 years) were followed for 189 [plusminus] 68 days.
RESULTS: Of the 90 patients, 62% had partial and one third had generalized epilepsy. Median baseline seizure frequency was 24/month. At endpoint, the mean TPM dosage was 4.6 mg/kg body weight. Mean seizure reduction was 80% (p[lt]0.001 vs. baseline). The responder rate ([gte]50% seizure reduction) was 78.7%, with 19.7% of these remaining seizure free for [gte]3 months. Overall tolerability was rated very good or good by 69% of patients or relatives and 77% of the physicians. The most frequently reported adverse events were anorexia (20%), somnolence (17.8%), and aggressiveness (7.7%). Weight change from baseline to endpoint was +0.3 [plusminus] 2.8 kg.
CONCLUSIONS: In children and adolescents [lte]16 years of age topiramate add-on proved to be effective and well tolerated in both partial and generalized seizures.
[Supported by: This study was funded by Janssen-Cilag Germany.]; (Disclosure: Salary - Andreas Schreiner is a full-time employee of Janssen-Cilag Germany.)