Abstract

Eslicarbazepine acetate (ESL) is an anti-epileptic drug approved for use as adjunctive therapy for focal-onset seizures (FOSs) in children. Evidence on the efficacy and safety of antiepileptic drugs in children remains limited. This study aimed to evaluate the safety and efficacy of ESL as an adjunct treatment for FOSs in children aged less than 18 years. Two randomized, double-blind, placebo-controlled trials were identified, comprising 386 pediatric participants. Adjunctive ESL, compared with placebo, was associated with a significant reduction in the overall frequency of seizures (mean difference 14.8%, 95% CI: 4.4 to 25.2; p = 0.0052). ESL therapy had a statistically significant increase in treatment-emerging adverse events (risk ratio 1.42, 95% CI: 1.07 to 1.88; p = 0.0158), with most being of mild to moderate severity. Adjunctive ESL was found to be effective in reducing the seizure frequency and was well-tolerated in children.

Key words: Adolescents, antiepileptic drugs, children, epilepsy, pediatric, seizure, systematic review