Eslicarbazepine acetate: a review of its use as adjunctive therapy in refractory partial-onset seizures.

Eslicarbazepine acetate (Aptiom(®), Zebinix(®)) is approved for the adjunctive treatment of partial-onset seizures in adults aged ≥18 years. Adjunctive therapy with oral eslicarbazepine acetate 800 or 1,200 mg once daily was associated with a significantly lower standardized seizure frequency (primary endpoint) than placebo in patients aged ≥18 years with refractory partial-onset seizures in three, randomized, double-blind, multinational, phase III trials. In a fourth randomized, double-blind, multinational, phase III trial in patients aged ≥16 years with refractory partial-onset seizures, adjunctive eslicarbazepine acetate 1,200 mg once daily, but not 800 mg once daily, was associated with a significantly lower standardized seizure frequency (primary endpoint). Responder rates were significantly higher with eslicarbazepine acetate 1,200 mg once daily than with placebo in these four trials, and with eslicarbazepine acetate 800 mg once daily than with placebo in two trials. The efficacy of eslicarbazepine acetate was maintained in the longer term, according to the results of 1-year extension studies. Adjunctive therapy with oral eslicarbazepine acetate was generally well tolerated in patients with refractory partial-onset seizures, with most adverse events being of mild to moderate severity. In conclusion, eslicarbazepine acetate is a useful option for the adjunctive treatment of patients with refractory partial-onset seizures.

RCT Entities:   Population Interventions Outcomes