Add-on levetiracetam in children and adolescents with refractory epilepsy: Results of an open-label multi-centre study
European Journal of Paediatric Neurology , Volume 12 - Issue 4 p. 321- 327
Purpose: To study the efficacy and tolerability of add-on levetiracetam in children and adolescents with refractory epilepsy. Methods: In this prospective multi-centre, open-label, add-on study, 33 children aged 4-16 years (median 8.5 years) with epilepsy refractory to at least two antiepileptic drugs were treated with levetiracetam in addition to their present treatment regimen with a follow-up of 26 weeks. The starting dose of 10 mg/kg/day was increased with 2-week steps of 10 mg/kg/day, if necessary, up to a maximum dose of 60 mg/kg/day. Results: Retention rate was 69.7% after 26 weeks on a median levetiracetam dosage of 22 mg/kg/day. Four children dropped-out because levetiracetam was ineffective, four because seizure frequency increased and/or seizures became more severe, and two because they developed aggressive behaviour. Compared to their baseline seizure frequency, 13 children (39.4%) had a >50% seizure reduction 12 weeks after initiation of levetiracetam, and 17 children (51.5%) at 26 weeks. At 26 weeks, nine children (27.3%) had been seizure-free for at least the last 4 weeks, terminal remission ranged from 0 to 187 days (mean 46 days). Levetiracetam was effective in both partial and primary generalized seizures, but had most effect in partial seizures. Most reported side effects were hyperactivity (48.5%), somnolence (36.4%), irritability (33.3%) and aggressive behaviour (27.3%). Severity of most side effects was mild. Five children had a serious adverse event, which all concerned hospital admissions that were not related to levetiracetam use. Conclusion: Levetiracetam proved to be an effective and well-tolerated add-on treatment in this group of children with refractory epilepsy.
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|European Journal of Paediatric Neurology|
|Organisation||Erasmus MC: University Medical Center Rotterdam|
Callenbach, P.M.C, Arts, W.F.M, ten Houten, R, Augustijn, P, Gunning, W.B, Peeters, E.A, … Brouwer, O.F. (2008). Add-on levetiracetam in children and adolescents with refractory epilepsy: Results of an open-label multi-centre study. European Journal of Paediatric Neurology, 12(4), 321–327. doi:10.1016/j.ejpn.2007.09.004