Background: In the treatment of pediatric epilepsy, there is a critical demand for effective and safe therapeutic options to address patients’ unmet clinical needs. Eslicarbazepine acetate is a novel once-daily antiepileptic drug and a third-generation single enantiomer member of the dibenzazepine family. Objective: The objective of this study was to evaluate the efficacy and safety of eslicarbazepine acetate as add-on treatment for focal-onset seizures in pediatric patients using meta-analytical techniques. Methods: Randomized, placebo-controlled, single- or double-blinded add-on trials of eslicarbazepine acetate in patients < 18 years of age with focal-onset seizures uncontrolled by concomitant stable antiepileptic drug regimens were identified through a systematic literature search. The assessed outcomes included the mean relative change and ≥ 50% reduction in the baseline seizure frequency, the incidence of treatment withdrawal, serious adverse events, and treatment-emergent adverse events. Risk ratio and weighted mean difference with 95% confidence intervals were estimated for dichotomous/continuous outcomes. Results: Two trials were included involving 386 participants (age range 2–18 years), 217 for eslicarbazepine acetate and 169 for placebo groups, respectively. At the dosage of 30 mg/kg/day, eslicarbazepine acetate-treated patients had a significantly greater reduction in baseline seizure frequency (weighted mean difference − 21.67, 95% confidence interval − 40.87 to − 2.46; p = 0.027) and 58 patients (44.6%) were seizure responders compared with 27 controls (29.7%) [risk ratio 1.48, 95% confidence interval 0.99–2.20; p = 0.055]. There were no differences in treatment withdrawal (risk ratio 1.24, 95% confidence interval 0.65–2.37; p = 0.513), serious adverse events (risk ratio 1.40, 95% confidence interval 0.69–2.86; p = 0.350), and treatment-emergent adverse events (risk ratio 1.07, 95% confidence interval 0.94–1.22; p = 0.313). Conclusions: Adjunctive eslicarbazepine acetate could be an effective well-tolerated option in children and adolescents with focal-onset seizures uncontrolled by one or more concomitant anti-epileptic drugs.
Adjunctive Eslicarbazepine Acetate in Pediatric Patients with Focal Epilepsy: A Systematic Review and Meta-Analysis
Verrotti A.;
2018
Abstract
Background: In the treatment of pediatric epilepsy, there is a critical demand for effective and safe therapeutic options to address patients’ unmet clinical needs. Eslicarbazepine acetate is a novel once-daily antiepileptic drug and a third-generation single enantiomer member of the dibenzazepine family. Objective: The objective of this study was to evaluate the efficacy and safety of eslicarbazepine acetate as add-on treatment for focal-onset seizures in pediatric patients using meta-analytical techniques. Methods: Randomized, placebo-controlled, single- or double-blinded add-on trials of eslicarbazepine acetate in patients < 18 years of age with focal-onset seizures uncontrolled by concomitant stable antiepileptic drug regimens were identified through a systematic literature search. The assessed outcomes included the mean relative change and ≥ 50% reduction in the baseline seizure frequency, the incidence of treatment withdrawal, serious adverse events, and treatment-emergent adverse events. Risk ratio and weighted mean difference with 95% confidence intervals were estimated for dichotomous/continuous outcomes. Results: Two trials were included involving 386 participants (age range 2–18 years), 217 for eslicarbazepine acetate and 169 for placebo groups, respectively. At the dosage of 30 mg/kg/day, eslicarbazepine acetate-treated patients had a significantly greater reduction in baseline seizure frequency (weighted mean difference − 21.67, 95% confidence interval − 40.87 to − 2.46; p = 0.027) and 58 patients (44.6%) were seizure responders compared with 27 controls (29.7%) [risk ratio 1.48, 95% confidence interval 0.99–2.20; p = 0.055]. There were no differences in treatment withdrawal (risk ratio 1.24, 95% confidence interval 0.65–2.37; p = 0.513), serious adverse events (risk ratio 1.40, 95% confidence interval 0.69–2.86; p = 0.350), and treatment-emergent adverse events (risk ratio 1.07, 95% confidence interval 0.94–1.22; p = 0.313). Conclusions: Adjunctive eslicarbazepine acetate could be an effective well-tolerated option in children and adolescents with focal-onset seizures uncontrolled by one or more concomitant anti-epileptic drugs.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
