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拉科酰胺:癫痫患者局灶性发作的治疗评价。

Lacosamide: A Review in Focal Seizures in Patients with Epilepsy.

机构信息

Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.

出版信息

Drugs. 2015 Dec;75(18):2143-54. doi: 10.1007/s40265-015-0514-7.

DOI:10.1007/s40265-015-0514-7
PMID:26607484
Abstract

Lacosamide (Vimpat(®)) is a functionalized amino acid available orally (as a solution or tablets) and as an intravenous infusion for use as monotherapy (only in the USA) or adjunctive therapy for the treatment of focal seizures in adult and adolescent (aged ≥17 years in the USA) patients with epilepsy. As adjunctive therapy to other antiepileptic drugs (AEDs), lacosamide provided effective seizure control and was generally well tolerated in adults and adolescents (aged ≥16 years) in randomized clinical trials and in the real-world setting. In clinical trials, adjunctive lacosamide provided significantly greater reductions in 28-day seizure rates than adjunctive placebo, with these benefits maintained after up to 8 years of therapy in open-label extension studies. Moreover, patients were effectively switched from oral to short-term intravenous adjunctive therapy at the same dosage, which may be particularly beneficial in situations where oral therapy is not suitable. Conversion to lacosamide monotherapy was superior to a historical-control cohort in patients with focal seizures converting from previous AED therapy. In the absence of head-to-head comparisons with other AEDs, the exact position of lacosamide relative to other AEDs remains to be fully determined. In the meantime, oral and intravenous lacosamide provides a useful option as monotherapy (only in the USA) or adjunctive therapy for the treatment of focal seizures in adult and adolescent (aged ≥17 years in the USA) patients with epilepsy.

摘要

拉考沙胺(Vimpat(®))是一种可口服(溶液或片剂)和静脉输注的功能性氨基酸,可作为单药治疗(仅在美国)或辅助治疗用于治疗成人和青少年(美国为≥17 岁)癫痫患者的局灶性发作。作为其他抗癫痫药物(AEDs)的辅助治疗药物,拉考沙胺在随机临床试验和真实世界环境中为成人和青少年(≥16 岁)提供了有效的癫痫发作控制,并且通常具有良好的耐受性。在临床试验中,与辅助安慰剂相比,辅助拉考沙胺使 28 天发作率显著降低,在开放标签扩展研究中,这些益处可维持长达 8 年的治疗。此外,患者可以有效地从口服转为短期静脉辅助治疗,而无需调整剂量,这在口服治疗不合适的情况下可能特别有益。与之前的 AED 治疗转换为局灶性发作的患者相比,转换为拉考沙胺单药治疗的疗效优于历史对照队列。由于没有与其他 AED 进行头对头比较,因此拉考沙胺相对于其他 AED 的确切地位仍有待充分确定。在此期间,口服和静脉内拉考沙胺为美国≥17 岁的成人和青少年(美国为≥17 岁)癫痫患者的局灶性发作提供了一种有用的单药治疗(仅在美国)或辅助治疗选择。

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1
Lacosamide: A Review in Focal Seizures in Patients with Epilepsy.拉科酰胺:癫痫患者局灶性发作的治疗评价。
Drugs. 2015 Dec;75(18):2143-54. doi: 10.1007/s40265-015-0514-7.
2
A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study.一项在日常临床实践中评估拉考酰胺添加到单药治疗对部分性发作癫痫患者有效性和安全性的非干预性研究:VITOBA研究。
Epilepsia. 2015 Dec;56(12):1921-30. doi: 10.1111/epi.13224. Epub 2015 Nov 3.
3
Lacosamide: A Review in Focal-Onset Seizures in Patients with Epilepsy.拉考酰胺:一项用于癫痫局灶性发作患者的综述。
CNS Drugs. 2018 May;32(5):473-484. doi: 10.1007/s40263-018-0523-7.
4
Safety and tolerability of lacosamide as adjunctive therapy for adults with partial-onset seizures: Analysis of data pooled from three randomized, double-blind, placebo-controlled clinical trials.拉科酰胺作为成人部分性发作辅助治疗的安全性和耐受性:来自三项随机、双盲、安慰剂对照临床试验的汇总数据分析
Epilepsy Behav. 2015 Nov;52(Pt A):119-27. doi: 10.1016/j.yebeh.2015.09.006. Epub 2015 Sep 27.
5
Lacosamide: a review of its use as adjunctive therapy in the management of partial-onset seizures.拉科酰胺:关于其作为辅助治疗用于部分性发作管理的综述
CNS Drugs. 2013 Dec;27(12):1125-42. doi: 10.1007/s40263-013-0123-5.
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Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial.拉科酰胺辅助治疗未控制部分发作性癫痫患者的长期安全性和疗效:III 期开放标签扩展试验结果。
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A pooled analysis of lacosamide clinical trial data grouped by mechanism of action of concomitant antiepileptic drugs.拉科酰胺临床试验数据的汇总分析按伴随抗癫痫药物作用机制分组。
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Examining the clinical utility of lacosamide: pooled analyses of three phase II/III clinical trials.研究拉考沙胺的临床实用性:三项 II/III 期临床试验的汇总分析。
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Safety and tolerability of adjunctive lacosamide intravenous loading dose in lacosamide-naive patients with partial-onset seizures.在部分发作性癫痫患者中,添加左乙拉西坦静脉负荷剂量的安全性和耐受性。
Epilepsia. 2013 Jan;54(1):58-65. doi: 10.1111/j.1528-1167.2012.03543.x. Epub 2012 Jun 18.
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[The experience treatment of adjunctive lacosamide for patients with drug-resistance partial epilepsy].[拉考酰胺辅助治疗耐药性部分性癫痫患者的经验性治疗]
Zh Nevrol Psikhiatr Im S S Korsakova. 2013;113(9):23-8.

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本文引用的文献

1
A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study.一项在日常临床实践中评估拉考酰胺添加到单药治疗对部分性发作癫痫患者有效性和安全性的非干预性研究:VITOBA研究。
Epilepsia. 2015 Dec;56(12):1921-30. doi: 10.1111/epi.13224. Epub 2015 Nov 3.
2
Safety and tolerability of lacosamide as adjunctive therapy for adults with partial-onset seizures: Analysis of data pooled from three randomized, double-blind, placebo-controlled clinical trials.拉科酰胺作为成人部分性发作辅助治疗的安全性和耐受性:来自三项随机、双盲、安慰剂对照临床试验的汇总数据分析
Epilepsy Behav. 2015 Nov;52(Pt A):119-27. doi: 10.1016/j.yebeh.2015.09.006. Epub 2015 Sep 27.
3
成人癫痫患者根据发作类型选择抗癫痫药物
J Clin Neurol. 2020 Oct;16(4):547-555. doi: 10.3988/jcn.2020.16.4.547.
4
Lacosamide: A Review in Focal-Onset Seizures in Patients with Epilepsy.拉考酰胺:一项用于癫痫局灶性发作患者的综述。
CNS Drugs. 2018 May;32(5):473-484. doi: 10.1007/s40263-018-0523-7.
5
Lacosamide in patients with gliomas and uncontrolled seizures: results from an observational study.拉考沙胺治疗胶质瘤伴发癫痫发作控制不佳的患者:一项观察性研究的结果。
J Neurooncol. 2018 Jan;136(1):105-114. doi: 10.1007/s11060-017-2628-0. Epub 2017 Oct 13.
Efficacy and safety of lacosamide as first add-on or later adjunctive treatment for uncontrolled partial-onset seizures: A multicentre open-label trial.拉科酰胺作为难治性部分性发作的初始添加治疗或后续辅助治疗的疗效和安全性:一项多中心开放标签试验。
Seizure. 2015 Sep;31:72-9. doi: 10.1016/j.seizure.2015.07.001. Epub 2015 Jul 10.
4
Long-term adjunctive lacosamide treatment in patients with partial-onset seizures.拉科酰胺对部分性发作患者的长期辅助治疗
Acta Neurol Scand. 2016 Feb;133(2):136-144. doi: 10.1111/ane.12451. Epub 2015 Jul 2.
5
Clinical pharmacokinetic and pharmacodynamic profile of lacosamide.拉科酰胺的临床药代动力学和药效学特征。
Clin Pharmacokinet. 2015 Sep;54(9):901-14. doi: 10.1007/s40262-015-0276-0.
6
Lacosamide cardiac safety: clinical trials in patients with partial-onset seizures.拉科酰胺的心脏安全性:部分性发作患者的临床试验
Acta Neurol Scand. 2015 Nov;132(5):355-63. doi: 10.1111/ane.12414. Epub 2015 Apr 30.
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Lacosamide cardiac safety: a thorough QT/QTc trial in healthy volunteers.拉科酰胺的心脏安全性:一项在健康志愿者中进行的全面QT/QTc试验。
Acta Neurol Scand. 2015 Nov;132(5):346-54. doi: 10.1111/ane.12416. Epub 2015 Apr 30.
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Cognitive effects of lacosamide as adjunctive therapy in refractory epilepsy.拉考酰胺作为难治性癫痫辅助治疗的认知效应。
Acta Neurol Scand. 2015 Jun;131(6):347-54. doi: 10.1111/ane.12372. Epub 2015 Jan 28.
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Early add-on lacosamide in a real-life setting: results of the REALLY study.现实环境中早期加用拉科酰胺:REALLY研究结果
Clin Drug Investig. 2015 Feb;35(2):121-31. doi: 10.1007/s40261-014-0255-5.
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Assessment of the effects of lacosamide on sleep parameters in healthy subjects.拉科酰胺对健康受试者睡眠参数影响的评估。
Seizure. 2015 Feb;25:155-9. doi: 10.1016/j.seizure.2014.10.012. Epub 2014 Oct 25.