Research Centre for Pharmaceutical Care and Pharmacoeconomics, Katholieke Universiteit Leuven, Leuven, Belgium.
Curr Med Res Opin. 2011 Jul;27(7):1329-38. doi: 10.1185/03007995.2011.582863. Epub 2011 May 12.
This article provides a short but comprehensive pharmacotherapeutic update of adjunctive therapy with lacosamide for partial-onset seizures in adult patients.
PubMed, Centre for Reviews and Dissemination databases, Cochrane Database of Systematic Reviews, EconLit were searched from January 1999 to September 2010. Studies evaluating intravenous lacosamide were excluded because this article focuses on chronic adjunctive therapy.
Three randomised, multicentre, double-blind, placebo-controlled trials have investigated the efficacy of lacosamide in 1300 adults with epilepsy. The median percent reduction in seizure frequency per 28 days from baseline to maintenance was 18.4% for placebo, 33.3% for lacosamide 200 mg/day (p < 0.01), 36.8% for 400 mg/day (p < 0.001), 39.4% for 600 mg/day. The percentage of patients attaining a seizure frequency reduction of ≥50% was 22.6% with placebo, 34.1% with lacosamide 200 mg/day (p < 0.05), 39.7% with lacosamide 400 mg/day (p < 0.001), 39.6% with lacosamide 600 mg/day. Three open-label extension studies showed that long-term treatment with lacosamide produced sustained efficacy in and was well-tolerated by patients. Three economic evaluations used a similar design to determine the cost effectiveness of lacosamide from the healthcare payer perspective in Sweden, Finland and Belgium. These studies showed that standard anti-epileptic drug therapy plus lacosamide is likely to constitute a cost-effective alternative. The budget impact of introducing lacosamide is likely to be limited.
The evidence on lacosamide was limited and studies suffered from a number of methodological limitations. Lacosamide appears to be a safe, efficacious and cost-effective adjunctive therapy for partial-onset epileptic seizures in adult patients. However, these results need to be validated by studies that explore the impact of lacosamide in real-life clinical practice.
本文提供了左乙拉西坦辅助治疗成人部分发作性癫痫的简短但全面的药物治疗更新。
从 1999 年 1 月至 2010 年 9 月,检索了 PubMed、考科兰数据库、系统评价 Cochrane 数据库、 EconLit。排除了评估静脉内左乙拉西坦的研究,因为本文重点关注慢性辅助治疗。
三项随机、多中心、双盲、安慰剂对照试验共纳入了 1300 例癫痫患者,评估了左乙拉西坦的疗效。从基线到维持期,每 28 天癫痫发作频率的中位数降低百分比分别为安慰剂组 18.4%,左乙拉西坦 200mg/天组 33.3%(p<0.01),左乙拉西坦 400mg/天组 36.8%(p<0.001),左乙拉西坦 600mg/天组 39.4%。达到癫痫发作频率降低≥50%的患者百分比分别为安慰剂组 22.6%,左乙拉西坦 200mg/天组 34.1%(p<0.05),左乙拉西坦 400mg/天组 39.7%(p<0.001),左乙拉西坦 600mg/天组 39.6%。三项开放标签扩展研究表明,长期左乙拉西坦治疗对患者具有持续疗效,且耐受性良好。三项经济学评价采用类似的设计,从瑞典、芬兰和比利时的医疗保健支付者的角度评估了左乙拉西坦的成本效益。这些研究表明,标准抗癫痫药物治疗加左乙拉西坦可能是一种具有成本效益的替代疗法。引入左乙拉西坦的预算影响可能有限。
左乙拉西坦的证据有限,研究存在一些方法学上的局限性。左乙拉西坦似乎是一种安全、有效且具有成本效益的成人部分发作性癫痫的辅助治疗药物。然而,这些结果需要通过研究来验证,以探讨左乙拉西坦在现实临床实践中的影响。