Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration | NSS
Idiopathic hypersomnia is a sleep disorder that causes daytime sleepiness. Many patients also have difficulty awakening, long sleep time at night, long and unrefreshing naps, and problems thinking clearly. Lower-sodium oxybate is a medicine used to treat symptoms of idiopathic hypersomnia.
Conclusions: During open-label treatment with LXB, participants showed clinically meaningful improvements in idiopathic hypersomnia symptoms and in quality of life and functional measures. TEAE incidence declined over LXB titration and optimization.
• Source: Nature and Science of Sleep
• Relevance: “These results show that lower-sodium oxybate improved symptoms of idiopathic hypersomnia and improved participants’ quality of life, day-to-day functioning, and ability to work. The results also show that side effects decreased with continued treatment.”
• U.S. researchers expounded on the efficacy and safety of lower-sodium oxybate (LXB; Xywav) during the open-label titration and optimization period (OLT) and stable-dose period (SDP) in a clinical study of idiopathic hypersomnia. The safety population included 154 patients, and the modified intent-to-treat population included 115 patients.
• The investigators found that in adults with idiopathic hypersomnia, the open-label administration of LXP improved symptoms and quality of life. These improvements started as early as week 1. The maintenance of improvement or further improvement occurred during titration and optimization, as well as at 2 weeks of stable dosing. No new safety signals were identified.
• “In the present study,” the authors wrote, “ similar efficacy was seen between participants entering and maintaining concomitant treatment with alerting agents (traditional stimulants or wake-promoting agents) and participants who were treatment naive, indicating that LXB may be useful as first-line therapy as a single agent, or in combination with alerting agents.”
• According to the authors, selection bias could have occurred during participant enrollment. Another limitation of the current study is the open-label design.