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布立西坦:癫痫患者部分性发作(局灶性)的综述

Brivaracetam: A Review in Partial-Onset (Focal) Seizures in Patients with Epilepsy.

作者信息

Hoy Sheridan M

机构信息

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

出版信息

CNS Drugs. 2016 Aug;30(8):761-72. doi: 10.1007/s40263-016-0376-x.

DOI:10.1007/s40263-016-0376-x
PMID:27503181
Abstract

Brivaracetam (Briviact(®); BRIVLERA™) is a high affinity synaptic vesicle protein 2A (SV2A) ligand available orally (as a tablet or solution) or intravenously (as a bolus or infusion) in various countries worldwide, including the USA, Canada and those of the EU. It is approved as adjunctive therapy for the treatment of partial-onset seizures (POS) in adults (aged ≥18 years) [USA, EU and Canada] and adolescents (aged 16 to <18 years) [USA and EU] with epilepsy. In multinational, phase III studies in adults and adolescents (aged ≥16 years), oral brivaracetam as adjunctive therapy to other antiepileptic drugs (AEDs) was generally associated with significant median percent reductions over placebo in seizure frequency and significant improvements in the proportion of patients achieving a ≥50 % reduction in seizure frequency compared with placebo. These benefits appeared to be sustained during up to 96 months' therapy in follow-up studies. Whether administered orally or intravenously, adjunctive brivaracetam was generally well tolerated in clinical studies, with the majority of treatment-emergent adverse events (TEAEs) being mild or moderate in intensity. In the absence of head-to-head studies, definitive conclusions on the comparative efficacy and tolerability of brivaracetam versus newer AEDs are not yet possible. In the meantime, brivaracetam extends the options currently available for the treatment of POS in patients aged ≥16 years with epilepsy.

摘要

布瓦西坦(Briviact(®); BRIVLERA™)是一种高亲和力的突触小泡蛋白2A(SV2A)配体,在全球多个国家(包括美国、加拿大以及欧盟各国)可通过口服(片剂或溶液)或静脉注射(推注或输注)给药。它被批准作为辅助疗法,用于治疗成人(≥18岁)[美国、欧盟和加拿大]及青少年(16至<18岁)[美国和欧盟]癫痫患者的部分性发作(POS)。在针对成人和青少年(≥16岁)的多国III期研究中,口服布瓦西坦作为其他抗癫痫药物(AEDs)的辅助疗法,与安慰剂相比,通常在癫痫发作频率方面有显著的中位数百分比降低,并且在癫痫发作频率降低≥50%的患者比例方面有显著改善。在后续研究中,这些益处似乎在长达96个月的治疗期间得以维持。无论口服还是静脉注射,辅助使用布瓦西坦在临床研究中总体耐受性良好,大多数治疗中出现的不良事件(TEAEs)强度为轻度或中度。由于缺乏头对头研究,目前还无法就布瓦西坦与新型AEDs的比较疗效和耐受性得出明确结论。与此同时,布瓦西坦为≥16岁癫痫患者的POS治疗扩展了现有选择。

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