[A randomised open trial comparing monotherapy with topiramate versus carbamazepine in the treatment of paediatric patients with recently diagnosed epilepsy]

Abstract

Introduction: In some studies in children, topiramate showed efficacy.

Aim: To evaluate efficacy, tolerability and safety of topiramate in monotherapy in newly diagnosed epilepsy vs carbamazepine in children.

Patients and methods: In a multicentre, open-label, comparative and randomized study patients with partial epilepsy, were randomized to received topiramate or carbamazepine treatment. Patients with degenerative disease were excluded. Data were analysed by SPSS statistical program v. 11.0, and non parametric test. Comparisons between groups were made with chi square test and t Student's test.

Results: In total were included 88 patients, 33 in group 1 (topiramate), 32 group 2 (carbamazepine), 23 were drop-outs because adverse events and lost in follow-up (13 in group 1 y 10 group 2). In both groups were observed good efficacy, in month 6 and 9 of follow-up, the average of seizures in group 1 were better than group 2 (p = 0.01, t Student's test). The percentage of free seizure patients was greater in group 1 than group 2 (statistical significance p = 0.02 chi square test). The adverse events were similar in both groups and mild, somnolence 9%, weight loss 6% in group 1 and somnolence 19%, dizziness 3% and seizure discontrol 3% in group 2.

Conclusions: Good efficacy in both groups, and topiramate in good treatment choice in newly diagnosed epilepsy in children because it's the efficacy and tolerability in comparison with the gold standard carbamazepine.