Elger Christian, Bialer Meir, Cramer Joyce A, Maia Joana, Almeida Luis, Soares-da-Silva Patrício
Department of Epileptology, University of Bonn, Bonn, Germany.
Epilepsia. 2007 Mar;48(3):497-504. doi: 10.1111/j.1528-1167.2007.00984.x. Epub 2007 Feb 21.
To explore the efficacy and safety of eslicarbazepine acetate (BIA 2-093), a new antiepileptic drug, as adjunctive therapy in adult patients with partial epilepsy.
A multicenter, double-blind, randomized, placebo-controlled study was conducted in 143 refractory patients aged 18-65 years with >or=4 partial-onset seizures/month. The study consisted of a 12-week treatment period followed by a 1-week tapering off. Patients were randomly assigned to one of three groups: treatment with eslicarbazepine acetate once daily (QD, n=50), twice daily (BID, n=46), or placebo (PL, n=47). The daily dose was titrated from 400 mg to 800 mg and to 1,200 mg at 4-week intervals. The proportion of responders (patients with a >or=50% seizure reduction) was the primary end point.
The percentage of responders versus baseline showed a statistically significant difference between QD and PL groups (54% vs. 28%; 90% CI =-infinity, -14; p=0.008). The difference between the BID (41%) and PL did not reach statistical significance (90% CI =-infinity, -1; p=0.12). A significantly higher proportion of responders in weeks 5-8 was found in the QD group than in the BID group (58% vs. 33%, respectively, p=0.022). At the end of the 12-week treatment, the number of seizure-free patients in the QD and BID groups was 24%, which was significantly different from the PL group. The incidence of adverse events was similar between the treatment groups and no drug-related serious adverse events occurred.
Eslicarbazepine acetate was efficacious and well tolerated as an adjunctive therapy of refractory epileptic patients.
探讨新型抗癫痫药物醋酸艾司利卡西平（BIA 2-093）作为辅助治疗药物用于成人部分性癫痫患者的疗效和安全性。
对143例年龄在18至65岁、每月至少发作4次部分性发作的难治性患者进行了一项多中心、双盲、随机、安慰剂对照研究。该研究包括为期12周的治疗期，随后是为期1周的逐渐减量期。患者被随机分为三组之一：每日一次服用醋酸艾司利卡西平（QD，n = 50）、每日两次（BID，n = 46）或安慰剂（PL，n = 47）。每日剂量以4周为间隔从400毫克滴定至800毫克，再滴定至1200毫克。应答者（癫痫发作减少≥50%的患者）的比例为主要终点。
与基线相比，QD组和PL组应答者的百分比显示出统计学上的显著差异（54%对28%；90%CI = -∞，-14；p = 0.008）。BID组（41%）和PL组之间的差异未达到统计学显著性（90%CI = -∞，-1；p = 0.12）。在第5至8周，QD组应答者的比例显著高于BID组（分别为58%对33%，p = 0.022）。在12周治疗结束时，QD组和BID组无癫痫发作患者的数量为24%，这与PL组有显著差异。各治疗组不良事件的发生率相似，未发生与药物相关的严重不良事件。
醋酸艾司利卡西平作为难治性癫痫患者的辅助治疗药物有效且耐受性良好。
