Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Via Conca 71, Ancona, 60020, Italy.
Department of Neuroscience, Biomedicine and Movement Science, University of Verona, Verona, Italy.
CNS Drugs. 2018 Mar;32(3):189-196. doi: 10.1007/s40263-018-0504-x.
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.
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.
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.
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).
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.
在儿科癫痫的治疗中，存在对有效和安全治疗选择的迫切需求，以满足患者未满足的临床需求。乙酰埃索卡巴西是一种新型的每日一次的抗癫痫药物，也是苯并二氮䓬家族的第三代单对映异构体成员。
本研究旨在使用荟萃分析技术评估乙酰埃索卡巴西作为添加治疗用于儿科局灶性发作癫痫患者的疗效和安全性。
通过系统文献检索，确定了在接受一种或多种同时使用的抗癫痫药物方案控制不佳的局灶性发作癫痫的<18 岁患者中进行的随机、安慰剂对照、单盲或双盲添加试验。评估的结局包括基线发作频率的平均相对变化和≥50%减少、治疗退出发生率、严重不良事件和治疗出现的不良事件。对于二分类/连续结局，使用风险比和加权均数差及其 95%置信区间进行估计。
纳入了两项涉及 386 名参与者（年龄 2-18 岁）的试验，其中 217 名接受乙酰埃索卡巴西治疗，169 名接受安慰剂治疗。在 30mg/kg/天的剂量下，乙酰埃索卡巴西治疗组患者的基线发作频率显著降低（加权均数差-21.67，95%置信区间-40.87 至-2.46；p=0.027），58 名患者（44.6%）为癫痫缓解者，而对照组为 27 名（29.7%）[风险比 1.48，95%置信区间 0.99-2.20；p=0.055]。治疗退出率无差异（风险比 1.24，95%置信区间 0.65-2.37；p=0.513）、严重不良事件（风险比 1.40，95%置信区间 0.69-2.86；p=0.350）和治疗出现的不良事件（风险比 1.07，95%置信区间 0.94-1.22；p=0.313）。
在一种或多种同时使用的抗癫痫药物控制不佳的局灶性发作癫痫的儿童和青少年中，辅助使用乙酰埃索卡巴西可能是一种有效且耐受良好的选择。
