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美金刚:对其用于中重度阿尔茨海默病的药物经济学综述。

Memantine: a pharmacoeconomic review of its use in moderate-to-severe Alzheimer's disease.

作者信息

Plosker Greg L, Lyseng-Williamson Katherine A

机构信息

Adis International Limited, Auckland, New Zealand.

出版信息

Pharmacoeconomics. 2005;23(2):193-206. doi: 10.2165/00019053-200523020-00010.

Abstract

Memantine (Ebixa, Namenda, Axura) is an uncompetitive NMDA receptor antagonist used in the management of patients with moderate-to-severe Alzheimer's disease. It is currently the only drug approved for use in these more advanced stages of the disease. Significant reductions in functional and cognitive decline have been demonstrated with memantine relative to placebo in randomised, double-blind trials in this patient population. Clinical trial and postmarketing surveillance data indicate that the drug is generally well tolerated. Two fully published modelled cost-effectiveness analyses of memantine in moderate-to-severe Alzheimer's disease have been conducted in the UK and Finland, in which patient progression was simulated through health states related to dependency, residential setting and cognitive function. Although the specific costs included in the analyses varied, as did the study perspective and geographical location, results of the base-case analyses consistently showed that memantine was dominant over no pharmacological treatment. In the UK and Finnish analyses, memantine increased the duration of independence by 1.3 and 4.1 months, respectively, and the time to institutionalisation by 0.8 and 1 month. Mean total per-patient costs were reduced by 1963 pounds over 2 years (2003 costs) in the UK analysis and by 1687 eurossover 5 years (2001 costs) in the Finnish analysis. Memantine was also associated with a small gain in quality-adjusted life expectancy in the UK model. In sensitivity analyses, memantine remained dominant for almost all plausible changes to key variables. Memantine reduced total societal costs by $1090 per patient per month (1999 costs) compared with no pharmacological treatment over 28 weeks in a resource utilisation and cost analysis conducted alongside a pivotal US trial in patients with moderate-to-severe Alzheimer's disease. Results were primarily driven by reductions in total caregiver costs, which included the opportunity cost of time spent in caregiving tasks, and in direct nonmedical costs, which included the cost of care in a nursing home or similar institution.In conclusion, in patients with moderate-to-severe Alzheimer's disease, memantine is associated with significant reductions in functional and cognitive decline compared with no pharmacological treatment. Available pharmacoeconomic data from Europe and the US, despite some inherent limitations, support the use of memantine as a cost-effective treatment in this patient population, although definitive conclusions are not feasible because of limited data.

摘要

美金刚(易倍申、盐酸美金刚片、Axura)是一种非竞争性N-甲基-D-天冬氨酸(NMDA)受体拮抗剂,用于治疗中重度阿尔茨海默病患者。它是目前唯一被批准用于该疾病更晚期阶段的药物。在针对该患者群体的随机双盲试验中,与安慰剂相比,美金刚已被证明能显著减少功能和认知能力下降。临床试验和上市后监测数据表明,该药物总体耐受性良好。英国和芬兰已对美金刚用于中重度阿尔茨海默病进行了两项全面发表的模拟成本效益分析,其中通过与依赖程度、居住环境和认知功能相关的健康状态来模拟患者病情进展。尽管分析中包含的具体成本不同,研究视角和地理位置也不同,但基础病例分析结果一致表明,美金刚比不进行药物治疗更具优势。在英国和芬兰的分析中,美金刚分别将独立时间延长了1.3个月和4.1个月,将入住机构护理的时间推迟了0.8个月和1个月。在英国的分析中,每位患者两年(2003年成本)的平均总成本降低了1963英镑;在芬兰的分析中,每位患者五年(2001年成本)的平均总成本降低了1687欧元。在英国的模型中,美金刚还使质量调整预期寿命略有增加。在敏感性分析中,对于关键变量的几乎所有合理变化,美金刚仍然占主导地位。在美国一项针对中重度阿尔茨海默病患者的关键试验同时进行的资源利用和成本分析中,与不进行药物治疗相比美金刚在28周内使每位患者每月的社会总成本降低了1090美元(1999年成本)。结果主要是由于护理总成本的降低,其中包括护理任务所花费时间的机会成本,以及直接非医疗成本的降低,其中包括养老院或类似机构的护理成本。总之,在中重度阿尔茨海默病患者中,与不进行药物治疗相比,美金刚能显著减少功能和认知能力下降。来自欧洲和美国的现有药物经济学数据,尽管存在一些固有局限性,但支持将美金刚作为该患者群体具有成本效益的治疗方法,不过由于数据有限,无法得出确定性结论。

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