Patients with narcolepsy easily transitioned from sodium oxybate to low-sodium oxybate treatment without complications while maintaining treatment effectiveness, according to study results presented at the 2024 American Academy of Neurology (AAN) annual meeting, held from April 13 to 18, 2024, in Denver, Colorado.
Low-sodium oxybate (ie, Xywav®) contains 92% less sodium than high-sodium oxybate (ie, Xyrem®, LumryzTM) and is approved for treating patients aged 7 and older with cataplexy and/or excessive daytime sleepiness, as well as adults with idiopathic hypersomnia.
Researchers at Jazz Pharmaceuticals conducted an open-label, multicenter study (SEGUE) to assess the safety, tolerability, effectiveness, and treatment optimization in patients with narcolepsy transitioning from sodium oxybate to low-sodium oxybate. Patients with narcolepsy types 1 or 2 on a stable sodium oxybate dose/regimen schedule were included in the study. Patients switched gram-per-gram to low-sodium oxybate for 6 weeks following 2 weeks of a stable sodium oxybate dose/regimen schedule. The Patient Global Impression of Change, forced preference questionnaire, ease of switching medication scale, and Epworth Sleepiness Scale were all used to collect efficacy and tolerability data at end of treatment or early discontinuation.
A total of 60 patients (women, 62%; White, 88%; mean age, 43.9) entered the intervention period. The median total nightly doses of low-sodium oxybate at the start and end of the study period were 8.5 g and 9.0 g, respectively, with most patients (93%) taking low-sodium oxybate twice nightly at both timepoints. A total of 56 patients completed the transition and the mean time to stable dose was 2.5 days, while the median number of changes in dose/regimen was 0.
According to the Patient Global Impression of Change, 45% of patients reported very much/much/minimal improvement in their narcolepsy symptoms and 48% of patients reported no change in narcolepsy symptoms. The forced preference questionnaire results demonstrated that 79% of patients preferred low-sodium oxybate over sodium oxybate, while the ease of switching medication scale demonstrated that 93% of patients reported an easy, extremely easy, or not difficult at all transition from sodium to low-sodium oxybate.
The average change measured by the Epworth Sleepiness Scale from baseline (n=55) was -0.7.
“Effectiveness of oxybate treatment (ESS) [Epworth Sleepiness Scale] was maintained after transition, and most preferred LXB [low-sodium oxybate] over SXB [sodium oxybate],” the researchers concluded.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
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References:
MacFadden W, Leary E, Pfister C, Fuller D. Effectiveness and optimization of low-sodium oxybate in participants with narcolepsy switching from sodium oxybate: final data from the substitution of equal grams of uninterrupted xyrem to xywav (SEGUE) study. Abstract presented at: 2024 AAN Annual Meeting; April 13-18, 2024; Denver, CO. Abstract P10.001.
