The efficacy, tolerability and safety of levetiracetam therapy in a pediatric population

•Levetiracetam is safe and effective as an initial monotherapy in childhood epileptic disorders, especially idiopathic epilepsy.•The efficacy of levetiracetam was independent of the seizure semiology, gender, and age.•The efficacy of levetiracetam was similar at the 3rd and 12th months of treatment.

PurposeThe purpose of this study was to assess the efficacy and safety of levetiracetam monotherapy in a pediatric population.MethodA retrospective review was performed of the charts of 351 consecutive children who were 6 months to 18 years of age and were treated with levetiracetam. Levetiracetam monotherapy was initiated and dosed to efficacy or unacceptable side effects, with a range of 10–112 mg/kg/day. Electroencephalographic examination was performed at pre-treatment and 12th months in the post-treatment period. Following the commencement of levetiracetam treatment, the retention rate at 3, 6 and 12 months was 100%, 75% and 57%, respectively.ResultsThe monotherapy retention rate at 3 and 12 months following the commencement of levetiracetam treatment was (231/351, 66%), and (126/200, 63%) respectively. A total of 165 (47%) patients had idiopathic epilepsy and 186 patients (53%) had symptomatic-cryptogenic epilepsy. The >90% seizure reduction rate was 65%, and the 50–90% seizure reduction rate was 14% at the 3rd month of treatment. Similarly, the >90% seizure reduction rate was 63%, and the 50–90% seizure reduction rate was 15% at the 12th month of treatment. EEG improvement (normalization of EEG) was observed in 65 (47%) patients. Overall, 61 (17%) patients showed adverse events. The most reported side effects were irritability (67%), hyperactivity (8%), somnolence (6%), behavioral disorders (5%), restlessness (5%), increased seizure frequency (3%), enuresis (2%), headache (2%) and attempted suicide (2%).ConclusionThe retrospective study of 231 consecutive pediatric patients to confirm that levetiracetam is effective as initial monotherapy for different types of seizures and/or epilepsy syndromes. However there is still a need for well-designed trials to justify the widespread use of levetiracetam monotherapy in children with specific epilepsy syndromes.