Thorpy Michael J, Kushida Clete A, Bogan Richard, Winkelman John, Ohayon Maurice M, Shapiro Colin M, Gudeman Jennifer
Albert Einstein College of Medicine, New York, NY, USA.
Stanford University School of Medicine, Stanford, CA, USA.
Sleep Med X. 2024 May 3;7:100113. doi: 10.1016/j.sleepx.2024.100113. eCollection 2024 Dec.
In the REST-ON clinical trial (NCT02720744), mean sleep latency on the Maintenance of Wakefulness Test (MWT) was significantly improved with extended-release once-nightly sodium oxybate (ON-SXB) vs placebo ( < 0.001) in participants with narcolepsy. This post hoc analysis assessed response to treatment and improvement in excessive daytime sleepiness.
Participants with narcolepsy aged ≥16 years were randomized 1:1 to receive ON-SXB (4.5 g, week 1; 6 g, weeks 2-3; 7.5 g, weeks 3-8; and 9 g, weeks 9-13) or placebo. Mean sleep latency on the MWT was measured across 5 trials of ≤30 min each. Post hoc assessments included percentage of participants whose sleep latency improved ≥5, ≥10, ≥15, and ≥20 min and with a mean sleep latency of 30 min.
Significantly more participants receiving ON-SXB vs placebo experienced increased mean sleep latency ≥5 min (all doses < 0.001), ≥10 min (all doses < 0.001), ≥15 min (6 and 7.5 g, < 0.001; 9 g, < 0.01), and ≥20 min (6 g, < 0.01; 7.5 g, < 0.001; 9 g, < 0.05). More participants receiving ON-SXB had mean sleep latency of 30 min vs placebo (6 g, 5.7 % vs 0 %, respectively [ < 0.05]; 7.5 g, 10.5 % vs 1.3 % [ < 0.05]; 9 g, 13.2 % vs 5.1 % [ = 0.143]).
Significantly more participants who received ON-SXB experienced increased mean sleep latency ≥5 to ≥20 min; at the 2 highest doses, >10 % remained awake for the entirety of the MWT. ON-SXB offers a once-at-bedtime treatment option for adults with narcolepsy.
在REST-ON临床试验（NCT02720744）中，发作性睡病患者服用每晚一次的缓释羟丁酸钠（ON-SXB）后，在清醒维持测试（MWT）中的平均睡眠潜伏期较安慰剂组有显著改善（P<0.001）。这项事后分析评估了治疗反应和日间过度嗜睡的改善情况。
年龄≥16岁的发作性睡病患者按1:1随机分组，分别接受ON-SXB（第1周4.5g；第2 - 3周6g；第3 - 8周7.5g；第9 - 13周9g）或安慰剂治疗。在每次时长≤30分钟的5次测试中测量MWT的平均睡眠潜伏期。事后评估包括睡眠潜伏期改善≥5、≥10、≥15和≥20分钟以及平均睡眠潜伏期达到30分钟的参与者百分比。
与安慰剂组相比，接受ON-SXB治疗的参与者中，平均睡眠潜伏期增加≥5分钟（所有剂量组，P<0.001）、≥10分钟（所有剂量组，P<0.001）、≥15分钟（6g和7.5g剂量组，P<0.001；9g剂量组，P<0.01）以及≥20分钟（6g剂量组，P<0.01；7.5g剂量组，P<0.001；9g剂量组，P<0.05）的人数显著更多。与安慰剂组相比，接受ON-SXB治疗且平均睡眠潜伏期达到30分钟的参与者更多（6g剂量组分别为5.7%和0%[P<0.05]；7.5g剂量组分别为10.5%和1.3%[P<0.05]；9g剂量组分别为13.2%和5.1%[P = 0.143]）。
接受ON-SXB治疗的参与者中，平均睡眠潜伏期增加≥5至≥20分钟的人数显著更多；在最高的两个剂量组中，超过10%的参与者在整个MWT测试期间保持清醒。ON-SXB为成年发作性睡病患者提供了一种睡前单次治疗选择。
