MAGNITUDE OF IMPROVEMENT IN EXCESSIVE DAYTIME SLEEPINESS WITH THE ONCE-AT-BEDTIME OXYBATE FOR NARCOLEPSY
Recommended Citation
Kushida CA, Thorpy MJ, Morse AM, Harsh J, Ortiz LE, Roth T, Dauvilliers Y, Dubow J, Gudeman J. MAGNITUDE OF IMPROVEMENT IN EXCESSIVE DAYTIME SLEEPINESS WITH THE ONCE-AT-BEDTIME OXYBATE FOR NARCOLEPSY. Sleep 2024; 47:A274.
Document Type
Conference Proceeding
Publication Date
5-1-2024
Publication Title
Sleep
Keywords
oxybate sodium, placebo, adult, aged, bedtime, bedtime dosage, Caucasian, conference abstract, controlled study, double blind procedure, drug therapy, Epworth sleepiness scale, excessive daytime sleepiness, female, human, intention to treat analysis, major clinical study, narcolepsy, narcolepsy with cataplexy, patient-reported outcome, post hoc analysis, randomized controlled trial
Abstract
Introduction: Safety and efficacy of once-nightly sodium oxybate (ON-SXB; LUMRYZ™) were investigated in the phase 3 REST-ON trial (NCT02720744). Results demonstrated statistically significant improvements in the secondary endpoint of excessive daytime sleepiness (EDS) measured using the Epworth Sleepiness Scale (ESS; P< 0.001 vs placebo) at all doses tested beginning at week 2 (post hoc analysis, ON-SXB 6 g vs placebo at week 2). The objective of this post hoc analysis was to assess the magnitude of improvement in the patient-reported outcome of EDS following treatment with ON-SXB. Methods: Participants aged ≥16 years with narcolepsy type 1 (NT1) or 2 (NT2) were randomized 1:1 to ON-SXB or placebo. Doses were 4.5 g week 1; 6 g weeks 2-3; 7.5 g weeks 4-8; and 9 g weeks 9-13. Median (interquartile range [IQR]) ESS scores were assessed for each dosing period. Results: Mean age of participants was 31.2 years, 68% were female, 75.5% were white, and 76.4% had NT1. The modified intent-to-treat population included 190 participants (ON-SXB, n=97; placebo, n=93). Baseline median (IQR) ESS scores were 17 (14-19) for ON-SXB and 18 (15-21) for placebo. At week 1, median (IQR) ESS scores were 16 (12-18) for ON-SXB 4.5 g vs 17 (13-20) for placebo. At week 3 (ON-SXB 6 g), median (IQR) ESS scores were 14 (10-18) vs 17 (14-20) for placebo. At week 8 (ON-SXB 7.5 g), median (IQR) ESS scores were 12 (8-16) vs 15.5 (12-20) for placebo. At week 13, median (IQR) ESS scores for ON-SXB 9.0 g were 9.5 (6.0-15.0) vs 15 (11-19) for placebo. Conclusion: Treatment with ON-SXB resulted in clinically meaningful improvements in EDS with doses ≥6 g, as median ESS scores were within the range considered normal (≤10) at the end of the trial. ON-SXB is considered an effective intervention in treatment of EDS for patients with narcolepsy with a once-at-bedtime dose.
Volume
47
First Page
A274
