Neurological
Lower sodium oxybate improves daytime sleepiness in patients with idiopathic hypersomnia
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Low-sodium oxybate (LXB) treatment improved daytime sleepiness in patients with idiopathic hypersomnia (IH), according to results from a placebo-controlled, double-blind, randomized phase 3 clinical trial presented during the American Academy of Neurology 2021 Annual Virtual Meeting, Nov. until April 22, 2021.
Patients (N = 154) with IH were recruited for this study. They received LXB Xywav, which contains 92% less sodium than Xyrem, for a 10-14 week open titration and optimization phase. After titration, patients were randomly assigned to continue LXB or to receive placebo for 2 weeks. The study researchers rated patients using the Epworth Sleepiness Scale (ESS), the patient’s global impression of change, and the IH severity scale.
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The patient has an average age of 40 years (standard deviation) [SD], ± 14) years, 68% were women, and the mean baseline ESS was 16 (SD, ± 3.6 points). After the titration period, the average LXB dose was optimized to 6.0 ± 1.6 g / night.
After the titration period, patients who were randomly switched to placebo had a significant deterioration in ESS scores (mean least squares difference: -6.51; 95% CI: -7.99 to -5.03 ; P <0.0001). Similarly, the IH severity scale scores were worse among placebo recipients (estimated mean difference: -12.00; 95% CI: -15.0 to -8.0; P <0.0001). The global impression of change in the patient was 88.1% in the placebo cohort and 21.4% in the treatment group (P <0.0001).
The most common adverse events of nausea (21.4%), headache (16.2%), dizziness (11.7%), vomiting (10.4%) and anxiety (10.4%) were less than a quarter the study participant reports. The study researchers observed a total of 4 serious adverse events (syncope, rhabdomyolysis, nephrolithiasis / pyelonephritis, and non-cardiac chest pain) but found that these were not associated with LXB treatment.
This study may have been limited by the short duration of the double-blind treatment.
The study’s authors concluded that LXB significantly improved excessive daytime sleepiness, general IH symptoms, and self-reported global changes in patients with IH. Xywav therapy was associated with a low risk of side effects.
Disclosure: Several authors have declared their affiliations with the industry. For a full list of details, see the original article.
reference
Dauvilliers Y., Arnulf I., Foldvary-Schaefer N. et al. Efficacy and Safety of Low Sodium Oxybate in a Phase 3 Placebo-Controlled, Double-Blind, Randomized Withdrawal Study in Adult Participants with Idiopathic Hypersomnia. Presented at: American Academy of Neurology 2021 Annual Virtual Meeting; 17.-22. April 2021.