Weight Loss With Once-nightly Sodium Oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial

作者：Thomas Roth, Anne Marie Morse, Richard Bogan, Asim Roy, Jennifer Gudeman, Yves Dauvilliers · 发表于：Clinical Therapeutics · 年份：2024 · DOI：10.1016/j.clinthera.2024.07.010 · 被引用次数：3 · 研究领域：Sleep and Wakefulness Research、Sleep and Work-Related Fatigue、Restless Legs Syndrome Research

Purpose 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. Findings 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/m 2 with ON-SXB and 0.08 (0.13) kg/m 2 with placebo (least squares mean difference [95% CI], −0.59 [−0.95 to −0.23] kg/m 2 ; P = 0.001). Excessive daytime sleepiness improved for both groups wit...