Résumé
Introduction Narcolepsy is a chronic disease with symptom onset frequently occurring between the ages of 10–25 years. Efficacy and safety of once-nightly sodium oxybate (ON-SXB; LUMRYZ™) were demonstrated in the phase 3 REST-ON trial. The objective of this post hoc analysis was to compare baseline narcolepsy characteristics among 3 age groups from REST-ON. Methods Participants aged ≥16 years with narcolepsy type 1/2 were enrolled in the randomized, double-blind, placebo-controlled REST-ON trial (NCT02720744). Baseline data were trichotomized post hoc by age subgroups (years, youngest: 16–25; middle: 26–34; oldest: 35–72). Results The safety analysis included 212 participants who received ≥1 dose of study drug (youngest, n=73; middle, n=70; oldest, n=69). For youngest, middle, and oldest participants, respectively, mean age was 20.6, 29.6, and 44.0 years; 63.0%, 68.6%, and 72.5%, were female. Respective mean baseline values for excessive daytime sleepiness (EDS) measures were similar across the youngest, middle, and oldest age groups (range of group means, mean sleep latency on the Maintenance of Wakefulness Test: 4.5–5.1, 4.6–5.0, 4.9–5.1 minutes; Clinical Global Impression of Severity for sleepiness rating: 4.8–5.3, 5.1–5.3, 5.1 [both treatment arms]; Epworth Sleepiness Scale score: 16.7–16.9, 15.2–17.9, 17.6–18.1). For objective disrupted nighttime sleep (DNS) measures determined by polysomnography, the middle group (range of group means, 58.1–68.2) and oldest group (63.4–66.3) had more sleep stage shifts to lighter stage of sleep/wake compared to the youngest group (50.5–56.3). The oldest group experienced a higher number of nocturnal arousals (range of group means, 83.5–87.2) compared to the middle (77.6–83.2) and youngest groups (65.4–80.7). Subjective DNS measures were similar across age groups (range of group means, visual analog scale [VAS] sleep quality, 1=did not sleep/100=slept very well: 48.3–60.7; VAS refreshing nature of sleep, 1=not refreshed/100=refreshed: 44.2–53.2). Conclusion Baseline measures of EDS were similar among age groups of participants with narcolepsy in the REST-ON trial. Objective but not subjective DNS measures were worse in older participants, suggesting DNS may increase with age. Support (if any) Avadel Pharmaceuticals