Efficacy of rivastigmine in subjects with moderately severe Alzheimer's disease
Efficacy of rivastigmine in subjects with moderately severe Alzheimer's disease
复制标题
DOI：
10.1002/gps.1058
复制
发表时间：
2004-03-01
影响因子：
4
通讯作者：
Quarg, P
中科院分区：
文献类型：
--
作者：
Burns, A;Spiegel, R;Quarg, P
背景胆碱酯酶（ChE）抑制剂主要用于治疗轻度至中度阿尔茨海默病（AD），但也可能是有效的，在更严重的diseases.Objective评估双重ChE抑制剂，rivastigmine，在更严重的dementia.Methods我们回顾性分析汇总数据从三个随机，安慰剂对照，双盲，6个月的试验，涉及2126 AD科目。根据基线简易精神状态检查（MMSE）评分选择受试者，以确定具有更严重认知障碍（10-12分MMSE）的受试者。纳入了117例接受rivastigmine 6-12 mg/天或安慰剂治疗的受试者。AD评估量表-认知子量表（ADAS-Cog）、MMSE、进行性恶化量表（PDS）的6项子评分和SDE VE-AD评估疗效。通过记录不良事件（AE）和停药的相对风险（RR）来评估耐受性。6个月后，安慰剂组的平均ADAS-Cog评分下降6.3分，卡巴拉汀组增加0.2分（观察病例; p < 0.001）。MMSE、PDS六项评分和SDE VE-AD项目也观察到临床获益。卡巴拉汀显示出与其他研究相同的AE模式，但因AE而脱落的RR低于轻度AD受试者。结论目前的治疗指南不建议使用胆碱酯酶抑制剂治疗重度AD患者。然而，这项回顾性分析表明，rivastigmine 6-12 mg/天可能使更重度疾病受试者以及轻度至中度损害受试者获益。版权所有（C）2004约翰威利父子有限公司。
Background Cholinesterase (ChE) inhibitors are primarily used in the treatment of mild to moderate Alzheimer's disease (AD), but may also be effective in more severe disease.Objective To evaluate the dual ChE inhibitor, rivastigmine, in more severe dementia.Methods We retrospectively analysed pooled data from three randomised, placebo-controlled, double-blind, 6-month trials, involving 2126 AD subjects. Subjects were selected according to baseline Mini-Mental State Examination (MMSE) score to identify subjects with more severe cognitive impairment (10-12 MMSE points). One-hundred-and-seventeen subjects were included who had been treated with rivastigmine 6-12 mg/day or placebo. The AD Assessment Scale-Cognitive Subscale (ADAS-Cog), the MMSE, a six-item subscore of the Progressive Deterioration Scale (PDS) and the BEHAVE-AD assessed efficacy. Tolerability was assessed by recording adverse events (AEs) and the relative risk (RR) of discontinuation.Results This group of subjects responded well to rivastigmine. After 6 months, the mean ADAS-Cog score declined by 6.3 points in the placebo group and increased by 0.2 points in the rivastigmine group (observed cases; p < 0.001). Clinical benefits were also observed with the MMSE, the six-item PDS score and items of the BEHAVE-AD. Rivastigmine showed the same pattern of AEs as in other studies, but the RR of dropping out due to AEs was lower than in subjects with milder AD.Conclusion Current treatment guidelines do not recommend treating individuals with severe AD with ChE inhibitors. However, this retrospective analysis suggests that rivastigmine 6-12 mg/day may benefit subjects with more severe disease, as well as subjects with mild to moderate impairment. Copyright (C) 2004 John Wiley Sons, Ltd.