多导睡眠图评估苏沃雷生治疗可能患有阿尔茨海默病痴呆和失眠的患者：一项随机试验。
Polysomnographic assessment of suvorexant in patients with probable Alzheimer's disease dementia and insomnia: a randomized trial.
机构信息
Merck & Co., Inc., Kenilworth, New Jersey.
Sleep Center, Emory University School of Medicine, Atlanta, Georgia.
出版信息
Alzheimers Dement. 2020 Mar;16(3):541-551. doi: 10.1002/alz.12035. Epub 2020 Jan 15.
INTRODUCTION
We evaluated the clinical profile of the orexin receptor antagonist suvorexant for treating insomnia in patients with mild-to-moderate probable Alzheimer's disease (AD) dementia.
METHODS
Randomized, double-blind, 4-week trial of suvorexant 10 mg (could be increased to 20 mg based on clinical response) or placebo in patients who met clinical diagnostic criteria for both probable AD dementia and insomnia. Sleep was assessed by overnight polysomnography in a sleep laboratory. The primary endpoint was change-from-baseline in polysomnography-derived total sleep time (TST) at week 4.
RESULTS
Of 285 participants randomized (suvorexant, N = 142; placebo, N = 143), 277 (97%) completed the trial (suvorexant, N = 136; placebo, N = 141). At week 4, the model-based least squares mean improvement-from-baseline in TST was 73 minutes for suvorexant and 45 minutes for placebo; (difference = 28 minutes [95% confidence interval 11-45], p < 0.01). Somnolence was reported in 4.2% of suvorexant-treated patients and 1.4% of placebo-treated patients.
DISCUSSION
Suvorexant improved TST in patients with probable AD dementia and insomnia.
简介
我们评估了食欲素受体拮抗剂苏沃雷生治疗轻度至中度可能的阿尔茨海默病（AD）痴呆患者失眠的临床特征。
方法
对符合可能的 AD 痴呆和失眠临床诊断标准的患者进行为期 4 周的苏沃雷生 10mg（可根据临床反应增加至 20mg）或安慰剂随机、双盲、对照试验。睡眠通过睡眠实验室的夜间多导睡眠图进行评估。主要终点是第 4 周多导睡眠图衍生的总睡眠时间（TST）的基线变化。
结果
285 名随机分组的参与者（苏沃雷生，N=142；安慰剂，N=143）中，277 名（97%）完成了试验（苏沃雷生，N=136；安慰剂，N=141）。第 4 周时，基于模型的最小二乘均数 TST 自基线的改善，苏沃雷生组为 73 分钟，安慰剂组为 45 分钟；（差异为 28 分钟[95%置信区间 11-45]，p<0.01）。苏沃雷生组有 4.2%的患者出现思睡，安慰剂组有 1.4%的患者出现思睡。
讨论
苏沃雷生改善了伴有失眠的可能的 AD 痴呆患者的 TST。
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