Outcome measure	Evidence	Implications
Disease-oriented evidence
Seizure frequency reduction	Randomized, placebo- controlled, double- blind, clinical trials and observational, open-label studies	Once-daily eslicarbazepine acetate at the dosage of 800 and 1,200 mg consistently demonstrated to be effective in the adjunctive treatment of adult patients presenting with focal onset seizures. A dose-dependent response occurred with an increase in effect by increasing the dose. In the pooled analysis of the Phase III pivotal trials, the median relative reduction in standardized seizure frequency was 33.4% and 37.8% in the eslicarbazepine acetate 800 mg and 1,200 mg daily dose groups and the responder rates were 33.8% and 43.1%, respectively. The drug efficacy was demonstrated regardless of whichever concomitant baseline, antiepileptic drugs were used. Open-label studies showed similar results and demonstrated sustained therapeutic effect of eslicarbazepine acetate.
Patient-oriented evidence
Tolerability and safety	Randomized, placebo- controlled, double- blind, clinical trials and observational, open-label studies	Once-daily eslicarbazepine acetate was well tolerated overall as adjunctive treatment in adults with focal onset epilepsy. In the pooled analysis of the Phase III trials, the incidence of treatment-emergent adverse events increased with increase of the dose (eslicarbazepine acetate 400 mg: 63.8%, eslicarbazepine acetate 800 mg: 67.0%, eslicarbazepine acetate 1,200 mg: 73.1%); most of the treatment-emergent adverse events were mild to moderate in intensity. The most common were dizziness, somnolence, headache and nausea. The incidence of adverse events was higher in patients co-treated with carbamazepine than with other antiepileptic drugs. Changes in mean laboratory parameters were not associated with clinically relevant findings, and there were no variations in vital signs, body weight or electrocardiography of clinical concern. Hyponatremia leading to treatment discontinuation occurred in less than 1% of the patients taking eslicarbazepine acetate. Similar results were observed in the open-label studies. Tolerability profile improved in patients switching from oxcarbazepine/carbamazepine to eslicarbazepine acetate due to side effects. No unexpected safety signals emerged over >5 years of follow-up.
Net benefit	Randomized, placebo- controlled, double- blind, clinical trials and observational, open-label studies	Starting treatment at the 400 mg/day dose, followed by 400 mg increments every 7–14 days until the optimal dose is reached, can maximize the balance of efficacy and tolerability.
Economic evidence	Not available