Abstract Introduction Low-sodium oxybate (LXB; Xywav®) is approved in the US for the treatment of idiopathic hypersomnia (IH) in adults. LYRICAL, a longitudinal, mixed methods study, examined the real-world treatment experience of US adults to provide details on the impact of LXB on a range of symptoms and treatment satisfaction in adults with IH. Methods Participants currently taking LXB for ≥12 weeks completed online surveys comprising standardized patient-reported outcome measures (including Patient Global Impressions of Change PGIC, Patient Global Impressions of Severity PGIS, and Treatment Satisfaction Questionnaire for Medication version 9 TSQM-9) and de novo questions at three timepoints (enrollment, week 12, and week 24). Qualitative interviews were conducted with a subset at enrollment and week 24. Data were analyzed descriptively. Results Forty participants with IH were enrolled (mean age: 32.7 years standard deviation (SD)=8.0; mean time taking LXB: 83.2 weeks (SD=65.9); most were female (72.5%), White (62.5%), and working full time (65.0%). The proportion of participants taking alerting agents decreased from 72.5% to 55.0% after LXB initiation. Most participants (89.5%) reported improvements in overall IH symptoms via PGIC after initiating LXB. Symptom-specific PGICs reflected improvements in excessive daytime sleepiness (EDS; 87.2%), feeling rested after nighttime sleep (89.7%), nighttime sleep quality (79.5%), and sleep inertia (89.7%). Participants reported high global treatment satisfaction (mean TSQM-9 score: 70.0), with 76.9% reporting being satisfied/extremely satisfied with LXB. Most (89.7%) reported improved quality of life (QoL) via PGIC after initiating LXB; improvements were maintained during the study. Among interviewees (n=13), most described feeling more awake/refreshed (76.9%) and improved sleep quality (61.5%) after starting LXB. Interviewees (12/12) reported improvement or complete resolution of EDS after initiating LXB. The majority of interviewees (61.5%) reported that prior treatments (e.g., alerting agents) were ineffective. All interviewees (100%) were satisfied/very satisfied with their LXB experience and reported being very likely to continue LXB. Conclusion Final results from the real-world LYRICAL study highlighted that many adults with IH experienced sustained improvements in multiple daytime and nighttime symptoms with LXB treatment, including EDS and nighttime sleep quality, as well as QoL benefits and high treatment satisfaction. Support (if any) Jazz Pharmaceuticals
Drachenberg et al. (Fri,) studied this question.
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