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

PURPOSE The purpose of this study was to assess the efficacy and safety of levetiracetam monotherapy in a pediatric population. METHOD A 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. RESULTS The 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%). CONCLUSION The 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.