Section of Epilepsy, Department of Neurology, Chang Gung Memorial Hospital at Linkou Medical Center, Chang Gung University College of Medicine, Taoyuan, Taiwan; Department of Neurology, Xiamen Chang Gung Hospital, Xiamen, China.
Section of Epilepsy, Department of Neurology, Chang Gung Memorial Hospital at Linkou Medical Center, Chang Gung University College of Medicine, Taoyuan, Taiwan.
Seizure. 2018 Nov;62:84-90. doi: 10.1016/j.seizure.2018.09.008. Epub 2018 Sep 14.
The aim of this trial was to compare the efficacy and safety of two formulations of levetiracetam in people with partial epilepsy over a 12-week treatment period.
We performed a randomized, paralleled, and multicenter trial that consisted of a 4-week single-blind placebo run-in, followed by a 12-week double-blind, double-dummy treatment phase to compare the efficacy and safety of levetiracetam extended-release (LEV-ER) and immediate-release (LEV-IR) tablets as an adjunctive treatment in adult patients with uncontrolled epilepsy.
The median partial-onset seizure (POS) frequency per week (min-max) was 0.3 (0.0, 17.4; 95% confidence interval [95% CI] 1.3, 4.8) in the LEV-ER group and 0.3 (0.0, 31.4; 95% CI - 0.1, 4.3) in the LEV-IR group. No serious adverse events occurred during the trial period. Both groups had the same responder rate (58.6%), while a higher rate of seizure freedom over the treatment period was noted in the LEV-ER group compared with the LEV-IR group (27.6% vs. 13.8%, respectively). The European Quality of Life-5 Dimensions scores significantly increased in the LEV-ER-treated group, in contrast to the scores in the LEV-IR group, which decreased (7.2 vs. - 1.5, p = 0.03).
These results suggest that LEV-ER is equivalent to LEV-IR in reducing the frequency of POS and has a similar tolerability as LEV-IR as an add-on therapy. In addition, LEV-ER treatment improved the health-related quality of life of people with uncontrolled partial epilepsy.
本试验旨在比较两种左乙拉西坦制剂在部分性癫痫患者中的疗效和安全性，治疗时间为 12 周。
我们进行了一项随机、平行、多中心试验，包括 4 周的单盲安慰剂导入期，随后进行 12 周的双盲、双模拟治疗期，以比较左乙拉西坦缓释片（LEV-ER）和速释片（LEV-IR）作为附加治疗在未控制的癫痫成人患者中的疗效和安全性。
LEV-ER 组每周部分发作性癫痫发作（POS）的中位数频率（最小-最大）为 0.3（0.0，17.4；95%置信区间[95%CI]为 1.3，4.8），LEV-IR 组为 0.3（0.0，31.4；95%CI 为-0.1，4.3）。试验期间未发生严重不良事件。两组的应答率相同（58.6%），而 LEV-ER 组在治疗期间的无发作率高于 LEV-IR 组（分别为 27.6%和 13.8%）。LEV-ER 治疗组的欧洲生活质量 5 维度评分显著升高，而 LEV-IR 组的评分则降低（7.2 对-1.5，p=0.03）。
这些结果表明，LEV-ER 可降低 POS 的频率，与 LEV-IR 相当，且作为附加治疗的耐受性与 LEV-IR 相似。此外，LEV-ER 治疗可改善未控制部分性癫痫患者的健康相关生活质量。
