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美金刚缓释片/多奈哌齐:阿尔茨海默病综述

Memantine ER/Donepezil: A Review in Alzheimer's Disease.

作者信息

Greig Sarah L

机构信息

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

出版信息

CNS Drugs. 2015 Nov;29(11):963-70. doi: 10.1007/s40263-015-0287-2.

Abstract

A once-daily, fixed-dose combination of memantine extended-release (ER)/donepezil 28/10 mg (Namzaric™) is available in the USA for patients with moderate to severe Alzheimer's disease (AD) on stable memantine and donepezil therapy. The fixed-dose formulation is bioequivalent to coadministration of the individual drugs. In a 24-week, phase III trial in patients with moderate to severe AD, addition of memantine ER 28 mg once daily to stable cholinesterase inhibitor (ChEI) therapy was more effective than add-on placebo on measures of cognition, global clinical status, dementia behaviour and semantic processing ability, although between-group differences on a measure of daily function did not significantly differ. In subgroup analyses in donepezil-treated patients, add-on memantine ER was more effective than add-on placebo on measures of cognition, dementia behaviour and semantic processing, although there were no significant between-group differences on measures of global clinical status and daily function. Memantine ER plus ChEI combination therapy was generally well tolerated in the phase III trial, with diarrhoea, dizziness and influenza occurring at least twice as often with add-on memantine ER as add-on placebo in donepezil-treated patients. Thus, memantine ER plus donepezil combination therapy is an effective and well tolerated treatment option for patients with moderate to severe AD. The fixed-dose combination is potentially more convenient than coadministration of the individual agents.

摘要

一种每日一次的美金刚缓释剂(ER)/多奈哌齐28/10毫克的固定剂量复方制剂(Namzaric™)在美国可用于正在接受稳定的美金刚和多奈哌齐治疗的中度至重度阿尔茨海默病(AD)患者。该固定剂量制剂与单独使用这两种药物联合给药具有生物等效性。在一项针对中度至重度AD患者的为期24周的III期试验中,在稳定的胆碱酯酶抑制剂(ChEI)治疗基础上,每日一次加用28毫克美金刚缓释剂在认知、整体临床状况、痴呆行为和语义处理能力指标方面比加用安慰剂更有效,尽管在日常功能指标上两组间差异无统计学意义。在多奈哌齐治疗患者的亚组分析中,加用美金刚缓释剂在认知、痴呆行为和语义处理指标方面比加用安慰剂更有效,尽管在整体临床状况和日常功能指标上两组间无显著差异。在III期试验中美金刚缓释剂加ChEI联合治疗总体耐受性良好,在多奈哌齐治疗的患者中,腹泻、头晕和流感的发生率加用美金刚缓释剂至少是加用安慰剂的两倍。因此,美金刚缓释剂加多奈哌齐联合治疗是中度至重度AD患者一种有效且耐受性良好的治疗选择。该固定剂量复方制剂可能比单独使用这两种药物联合给药更方便。

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