Preliminary efficacy of levetiracetam in children.

Treatment of seizures in pediatric patients is complicated by the fact that the etiology of the disorder and the pharmacokinetics, efficacy, and safety of antiepileptic drugs (AEDs) may differ from that in adults. With few controlled clinical trials of AEDs in children, the selection of agents to treat pediatric patients must be made on the basis of information from small uncontrolled studies or the extrapolation of clinical trial results in adults. Data from a large number of children with a wide range of seizure disorders who were treated in small-scale prospective studies, or whose records were retrospectively evaluated, indicate that levetiracetam reduces the frequency of seizures in pediatric patients. Available data also indicate that levetiracetam is well tolerated in pediatric patients, with a safety profile similar to that in adults, a low potential for behavioral disturbances, and no reported idiosyncratic adverse reactions. As with other AEDs, children metabolize and clear levetiracetam more rapidly than adults, and somewhat higher doses (based on body weight) are needed to achieve desired plasma concentrations. Several ongoing studies will provide further information on the pharmacokinetics, efficacy, and safety of levetiracetam in this patient population.