Efficacy and tolerability of levetiracetam 3000 mg/d in patients with refractory partial seizures: A multicenter, double-blind, responder-selected study evaluating monotherapy
Efficacy and tolerability of levetiracetam 3000 mg/d in patients with refractory partial seizures: A multicenter, double-blind, responder-selected study evaluating monotherapy
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DOI：
10.1111/j.1528-1157.2000.tb04605.x
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发表时间：
2000-10-01
期刊：
影响因子：
5.6
通讯作者：
Falter, T
中科院分区：
文献类型：
--
作者：
Ben-Menachem, E;Falter, T
目的：评估左乙拉西坦 (LEV) 单药治疗对选定的难治性部分性癫痫患者的疗效和耐受性。方法：在这项多中心、双盲、安慰剂对照、平行组、应答者选择研究中，患者被随机（2:1 比例）接受口服 LEV 1500 mg，每天两次，或在为期 12 周的附加阶段接受安慰剂。治疗有反应者（与基线相比，部分性发作频率减少 50% 或更多的患者）进入单一治疗阶段，包括最长 12 周的滴定期和 12 周 1500 mg 每日两次的单一治疗。在两个阶段中，均对应答率、癫痫发作频率和不良事件进行了分析。结果：共有 286 名患者（安慰剂，n = 105；LEV，n = 181）进入附加治疗阶段，86 名患者（安慰剂，n = 17；LEV，n = 69）有资格进入单一治疗阶段。接受 LEV 的 181 名患者中有 36 名 (19.9%) 完成了整个研究，而安慰剂组的 105 名患者中只有 10 名 (9.5%) (p = 0.029)。 LEV 完成研究的几率比安慰剂高 2.36 倍（95% 置信区间，1.08，5.57）。与安慰剂组相比，LEV 组在附加阶段的反应率显着较高（分别为 42.1% 和 16.7%；p < 0.001）。在 LEV 单药治疗组中，与基线相比，部分性发作频率的中位降低百分比为 73.8% (p = 0.037)，应答率为 59.2%。 9 名患者 (18.4%) 在 LEV 单药治疗后仍保持无癫痫发作。结论：对于对 3000 mg/d LEV 作为附加治疗有反应的难治性部分性癫痫发作患者，转换为 LEV 单药治疗（1500 mg 每日两次）是有效的且耐受性良好。
Purpose: To evaluate the efficacy and tolerability of levetiracetam (LEV) monotherapy in selected patients with refractory partial seizures.Methods: In this multicenter, double-blind, placebo controlled, parallel-group, responder-selected study, patients were randomized (2:1 ratio) to receive oral LEV 1500 mg twice daily or placebo during a 12-week add-on phase. Treatment responders (patients with a reduction in partial seizure frequency of 50% or more compared with baseline) entered a monotherapy phase that included a maximum 12-week down-titration period and 12 weeks of monotherapy at 1500 mg twice daily. In both phases, responder rate, seizure frequency, and adverse events were analyzed.Results: A total of 286 patients (placebo, n = 105; LEV, n = 181) entered the add-on phase, and 86 patients (placebo, n = 17; LEV, n = 69) were eligible for the monotherapy phase. Thirty-six of 181 patients (19.9%) who received LEV completed the entire study compared with only 10 of 105 patients (9.5%) in the placebo group (p = 0.029). The odds of completing the study on LEV were 2.36 times (95% confidence interval, 1.08, 5.57) higher than on placebo. The responder rate during the add-on phase was significantly higher in the LEV group compared with the placebo group (42.1% vs. 16.7%, respectively; p < 0.001). In the LEV monotherapy group, the median percent reduction in partial seizure frequency compared with baseline was 73.8% (p = 0.037), with a responder rate of 59.2%. Nine patients (18.4%) remained seizure-free on LEV monotherapy.Conclusions: Conversion to LEV monotherapy (1500 mg twice daily) is effective and well tolerated in patients with refractory partial seizures who responded to 3000 mg/d LEV as add-on therapy.