Abstract
Most children with new-onset epilepsy achieve seizure freedom with appropriate antiepileptic drugs (AEDs). However, nearly 20 % will continue to have seizures despite AEDs, as either monotherapy or in combination. Despite the growing market of new molecules over the last 20 years, the proportion of drug-resistant epilepsies has not changed. In this review, we report the evidence of efficacy and safety based on phase III randomized controlled clinical trials (RCTs) of AEDs currently used in the paediatric population. We conducted a literature search using the PubMed database and the Cochrane Database of Systematic Reviews. We also analysed the RCTs of newer AEDs whose efficacy in adolescents and adults might suggest possible use in children. Most of the phase III trials on AEDs in children have major methodological limitations that considerably limit meaningful conclusions about comparative efficacy between old and new molecules. Since the efficacy of new drugs has only been reported versus placebo, the commonly held opinion that new and newer AEDs have a better safety profile than old ones does not appear to be supported by evidence. Despite limited solid evidence, pharmacological management has improved over the years as a consequence of increased awareness of some degree of specificity of treatment in relation to different epilepsy syndromes and attention to adverse events. Future research should be directed taking these factors, as well as the diversity of epilepsy, into consideration.