Efficacy and tolerability of levetiracetam in children with epilepsy

Objective: To assess the efficacy and tolerability of levetiracetam (Lev) in children with epilepsy. Methods: Open-label observational, prospective, single arm, non-interventional study examining patients (<= 14 years) with epilepsy, receiving mono- or combination therapy with levetiracetam. Levetiracetam was started at a dose of approximately 10 mg/kg/day. The dose was titrated up with 10 mg/kg increments if seizures were poorly controlled but the maximum daily dose could not be more than 60 mg/kg/day. Documented were seizure type and frequency, levetiracetam dose and side effects. Results: 120 patients (39.3% females, mean age 4.5 +/- 3.9 years) were enrolled. Average duration of follow-up was 10.3 +/- 3.5 months. At study endpoint, 64.8% of patients got seizure free and 83.0% got a seizure reduction of >= 50%. Observed side effects were somnolence, dysphoria, nervousness, dystrophy, somnipathy, asitia, debilitation, etc. and the incidence rate in the study was 47.5%. Four (3.3%) of 120 patients withdrew because of intolerance of side effects. The estimated one year retention rate of levetiracetam was 73.3%. Poor effect was the most common reason for withdrawal. Conclusions: In our study, it seemed that levetiracetam was safe and effective for a wide range of epileptic seizures in children with epilepsy. (C) 2010 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.