吡仑帕奈用于治疗特发性全身性癫痫的原发性全身性强直阵挛发作。

Perampanel for the treatment of primary generalized tonic-clonic seizures in idiopathic generalized epilepsy.

作者信息

Rohracher Alexandra, Brigo Francesco, Höfler Julia, Kalss Gudrun, Neuray Caroline, Dobesberger Judith, Kuchukhidze Giorgi, Leitinger Markus, Trinka Eugen

机构信息

a Department of Neurology , Paracelsus Medical University Salzburg, and Christian Doppler Medical Centre , Salzburg , Austria.

c Centre for Cognitive Neurosciences Salzburg , Salzburg , Austria.

出版信息

Expert Opin Pharmacother. 2016 Jul;17(10):1403-11. doi: 10.1080/14656566.2016.1195810.

Abstract

INTRODUCTION

The non-competitive α-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) - receptor antagonist perampanel (PER) was approved in 2015 for treatment of primary generalized tonic-clonic seizures (pGTCS). The aim of this narrative review is to summarize available data on pharmacological properties, efficacy and tolerability of PER in pGTCs.

AREAS COVERED

Data sources included MEDLINE, EMBASE, Google Scholar and ClinicalTrials.gov, conference proceedings of the ILAE congresses and the most recent conference proceedings of the American Epilepsy Society (2013 to 2015).

EXPERT OPINION

A placebo-controlled clinical phase III study including 164 patients (≥ 12 years) with pGTCS in idiopathic generalized epilepsies (IGE) demonstrated efficacy of PER in reducing pGTCS with good tolerability profile, and without aggravating absence seizures or myoclonic seizures. Dizziness, the main adverse event (AE), can be avoided by bedtime administration. Psychiatric AEs ranging from mild depression to aggression and suicidal attempts should be especially monitored in patients with a history of psychiatric disorders. Co-administration of enzyme inducing antiepileptic drugs (AEDs) might decrease PER plasma levels and make dose adjustment necessary. A reduced efficacy of progesterone-containing oral contraceptives should be considered when administering PER to young women. There is lack of evidence on PER treatment in pregnancy. Although no teratogenic effects were observed in animal models, PER is not recommended for women of childbearing age without contraception.

摘要

引言

非竞争性α-氨基-3-羟基-5-甲基-4-异恶唑丙酸(AMPA)受体拮抗剂吡仑帕奈(PER)于2015年获批用于治疗原发性全面性强直阵挛发作(pGTCS)。本叙述性综述的目的是总结关于PER治疗pGTCS的药理特性、疗效和耐受性的现有数据。

涵盖领域

数据来源包括MEDLINE、EMBASE、谷歌学术和ClinicalTrials.gov、国际癫痫联盟大会会议记录以及美国癫痫协会最近的会议记录(2013年至2015年)。

专家意见

一项安慰剂对照的III期临床研究纳入了164例年龄≥12岁的特发性全身性癫痫(IGE)伴pGTCS患者,结果表明PER在减少pGTCS方面有效,耐受性良好,且不会加重失神发作或肌阵挛发作。通过睡前给药可避免主要不良事件(AE)头晕。有精神疾病史的患者应特别监测从轻度抑郁到攻击行为和自杀企图等精神方面的AE。酶诱导抗癫痫药物(AEDs)的联合使用可能会降低PER的血浆水平,因此需要调整剂量。在给年轻女性使用PER时,应考虑含孕酮口服避孕药的疗效降低。目前缺乏PER用于妊娠治疗的证据。尽管在动物模型中未观察到致畸作用,但不建议对未采取避孕措施的育龄妇女使用PER。

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