目的:嗜睡症患者比一般人群更容易肥胖。与体重相关的措施与延长释放的变化,在一项随机研究中评估每晚服用一次羟丁酸钠(ON-SXB)和体重减轻≥5%参与者的特征,该研究评估每晚服用一次羟丁酸钠(REST-ON)试验的疗效和安全性.
方法:REST-ON(NCT02720744)是III期,双盲,安慰剂对照,多中心,随机临床试验。年龄≥16岁的1型发作性睡病(NT1)或NT2患者接受ON-SXB或安慰剂治疗13周(第1周,4.5g;第2-3周,6g;第4-8周,7.5g;第9-13周,9g)。在基线和研究结束时测量体重和体重指数。
结果:基线时各组之间的体重相似(平均值[SD];ON-SXB,81.2[20.8]kg;N=107[NT1,n=80;NT2,n=27];安慰剂,82.1[22.5]kg;N=105[NT1,n=82;NT2,n=23])。在第13周(9克),ON-SXB组的平均(SD)体重减轻1.3(3.6)kg,安慰剂组的平均(SD)体重减轻0.2(2.6)kg;接受ON-SXB组的参与者中17.8%(19/107;NT1,n=14;NT2,n=5)的体重减轻≥5%,而接受安慰剂组(4/105;NT1,n=3;NT2,n=1;P=0.001).在第13周,ON-SXB的最小二乘平均(SE)体重指数相对于基线的变化为-0.51(0.13)kg/m2,安慰剂为0.08(0.13)kg/m2(最小二乘平均差[95%CI],-0.59[-0.95至-0.23]kg/m2;P=0.001)。ON-SXB两组白天过度嗜睡均得到改善,与其他亚组相比,≥5%体重减轻的亚组在维持清醒测试和Epworth嗜睡量表方面表现出更大的改善(体重减轻<5%,没有变化,或体重增加)(保持清醒测试,P=0.019;Epworth嗜睡量表评分,P<0.001)。
结论:发作性睡病通常与肥胖有关,这可能会增加心脏代谢风险。ON-SXB,一种有效的治疗白天过度嗜睡和猝倒,在超重或肥胖个体中可能是优选的,以提供更量身定制的治疗方法。
结果:
■NCT02720744。
OBJECTIVE: Individuals with
narcolepsy are more likely to be obese than the general population. Changes in weight-related measures with extended-release, once-nightly sodium oxybate (ON-SXB) and characteristics of participants with ≥5% weight loss were assessed in a Randomized
study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON)
trial post hoc analysis.
METHODS: REST-ON (NCT02720744) was a Phase III, double-blind, placebo-controlled, multicenter, randomized clinical
trial. Participants aged ≥16 years with narcolepsy type 1 (NT1) or NT2 received ON-SXB or placebo for 13 weeks (week 1, 4.5 g; weeks 2-3, 6 g; weeks 4-8, 7.5 g; and weeks 9-13, 9 g). Weight and body mass index were measured at baseline and
study end.
RESULTS: Weights were similar between groups at baseline (mean [SD]; ON-SXB, 81.2 [20.8] kg; N = 107 [NT1, n = 80; NT2, n = 27]; placebo, 82.1 [22.5] kg; N = 105 [NT1, n = 82; NT2, n = 23]). At week 13 (9 g), mean (SD) weight decreased 1.3 (3.6) kg with ON-SXB and increased 0.2 (2.6) kg with placebo; 17.8% (19/107; NT1, n = 14; NT2, n = 5) of participants receiving ON-SXB had ≥5% weight loss versus 3.8% receiving placebo (4/105; NT1, n = 3; NT2, n = 1; P = 0.001). At week 13, least squares mean (SE) body mass index change from baseline was ‒0.51 (0.13) kg/m2 with ON-SXB and 0.08 (0.13) kg/m2 with placebo (least squares mean difference [95% CI], -0.59 [-0.95 to -0.23] kg/m2; P = 0.001). Excessive daytime sleepiness improved for both groups with ON-SXB, the ≥5% weight-loss subgroup exhibited larger improvement in the Maintenance of Wakefulness Test and Epworth Sleepiness Scale versus the other subgroup (weight loss <5%, no change, or weight gain) (Maintenance of Wakefulness Test, P = 0.019; Epworth Sleepiness Scale score, P < 0.001).
CONCLUSIONS: Narcolepsy is often associated with obesity, which may increase cardiometabolic risks. ON-SXB, an effective treatment for excessive daytime sleepiness and cataplexy, may be preferred in overweight or obese individuals to provide a more tailored treatment approach.
RESULTS: UNASSIGNED: NCT02720744.