National Clinical Guideline Centre, Royal College of Physicians, London, UK.
Neuropsychiatr Dis Treat. 2013;9:467-76. doi: 10.2147/NDT.S32081. Epub 2013 Apr 8.
The goal of antiepileptic treatment is to achieve seizure freedom or seizure control. The aim of this paper is to review the evidence for the use of lacosamide for adjunctive treatment of refractory focal seizures with or without secondary generalization, within the scope of the 2012 update of the Clinical Guideline published by the National Institute for Health and Clinical Excellence (NICE).
Clinical evidence for the use of lacosamide and other antiepileptic drugs (AEDs) was systematically reviewed, evaluated, and presented to the Guideline Development Group. Only randomized clinical trials were included. Outcomes of clinical efficacy (seizure freedom, 50% reduction in seizure frequency, time to first seizure, time to 12-month remission, treatment withdrawal, and time to treatment withdrawal), experience of adverse events, and cognitive and quality of life outcomes were reviewed. A decision model was built to weigh the clinical benefits of each adjunctive AED, measured by seizure control and seizure reduction, compared with the harm from adverse events, as measured by withdrawals from treatment due to adverse events.
Lacosamide was included as part of the recommended AEDS to be used in tertiary epilepsy centers. The evidence review showed that more participants who received lacosamide as an adjunctive treatment had at least a 50% reduction in seizure frequency compared with those taking placebo. However, more participants on lacosamide were found to experience adverse events and withdrawal from treatment compared with those on placebo. The cost-effectiveness analysis showed that compared with placebo, the benefits gained from adjunctive lacosamide were modest and uncertain, whereas the costs were significantly high. Compared with other AEDs licensed for adjunctive therapy in focal seizures, lacosamide was associated with fewer quality-adjusted life years and higher costs. Therefore, the Guideline Development Group noted that the balance of benefit and harm needs to be carefully monitored in all patients.
抗癫痫治疗的目标是实现无发作或发作控制。本文旨在回顾拉科酰胺作为辅助治疗伴有或不伴有继发全面性发作的耐药局灶性癫痫发作的证据，范围是国家卫生与临床优化研究所（NICE）发布的临床指南 2012 年更新版。
对拉科酰胺和其他抗癫痫药物（AED）的临床证据进行了系统评价、评估，并提交给指南制定小组。仅纳入了随机临床试验。评价了临床疗效（无发作、发作频率减少 50%、首次发作时间、12 个月缓解时间、停药和停药时间）、不良事件体验以及认知和生活质量结局的相关结果。构建了一个决策模型，用于权衡每种辅助 AED 的临床获益，通过控制和减少发作来衡量，同时考虑因不良事件而退出治疗的危害。
拉科酰胺被纳入三级癫痫中心推荐使用的 AED 之一。证据回顾表明，与接受安慰剂治疗的患者相比，接受拉科酰胺辅助治疗的患者有更多的患者至少减少了 50%的发作频率。然而，与接受安慰剂治疗的患者相比，接受拉科酰胺治疗的患者出现更多的不良事件和停药。成本效益分析表明，与安慰剂相比，辅助拉科酰胺带来的获益适度且不确定，而成本却显著较高。与其他获准用于局灶性癫痫发作辅助治疗的 AED 相比，拉科酰胺与较低的质量调整生命年和更高的成本相关。因此，指南制定小组指出，需要在所有患者中仔细监测获益和危害之间的平衡。
