Background: The aim of this study was to evaluate the impact of different therapy regimens, including sodium oxybate (SXB)-containing regimens, on patient-reported outcomes (PROs) in people with narcolepsy.
Methods: Online surveys were used to collect information from persons with narcolepsy in the Nexus Narcolepsy Registry. Surveys contained questionnaires assessing self-reported sleep quality (SQ; via single question), daytime sleepiness and function (Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire), health-related quality of life (HRQoL; 36-Item Short Form Health Survey [SF-36]), work productivity and impairment (Work Productivity and Activity Impairment: Specific Health Problem), and history of injuries or motor vehicle accidents. Treatment with SXB (including monotherapy or combination therapy; SXB group) was compared with non-SXB therapy (No SXB group). The P values presented are nominal, as there are no adjustments for multiplicity.
Results: From June 2015 through December 2017, 983 participants completed 1760 surveys. SQ and daytime functioning scores were better in the SXB group compared with the No SXB group (all P < 0.001). HRQoL scores were better for the SXB group compared with the No SXB group for the SF-36 Physical Component (P = 0.016), Mental Component (P < 0.001), and all 8 subscales. Additionally, PROs were better for the SXB group for presenteeism, overall work and activity impairment, and risk of motor vehicle accidents (all P ≤ 0.001).
Conclusion: Based on participants' self-assessments, treatment regimens with SXB were associated with better outcomes than regimens not containing SXB across many PROs, including SQ, HRQoL, work and activities, and risk of traffic accidents. CLINICALTRIALS.
Gov Identifier: NCT02769780.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.sleep.2021.06.010 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Efficacy and safety of sodium oxybate treatment in adults with narcolepsy and cataplexy: a systematic review and meta-analysis.
Sleep Breath
November 2024
Faculty of Medicine, Al-Azhar University, Damietta, Egypt.
Article Synopsis
- Narcolepsy is a chronic condition marked by excessive daytime sleepiness and cataplexy, and sodium oxybate (SXB) has been identified as the only effective treatment for its symptoms.
- The study reviewed five randomized controlled trials (RCTs) to evaluate the effectiveness of SXB in reducing cataplexy attacks and improving wakefulness while also considering its safety by monitoring adverse events.
- Results showed that SXB significantly reduced weekly cataplexy attacks and improved outcomes on various tests compared to placebo, particularly at higher doses, indicating it is an effective treatment for managing narcolepsy symptoms with a reasonably safe profile.
Symptoms Burden as a Clinical Outcomes Assessment in Heart Failure Patients With Atrial Fibrillation.
JACC Heart Fail
November 2024
Division of Cardiology, University of Colorado School Anschutz Medical Campus, Aurora, Colorado, USA; Cardiovascular Institute, University of Colorado School Anschutz Medical Campus, Aurora, Colorado, USA; ARCA Biopharma, Westminster, Colorado, USA. Electronic address:
Background: Safe and effective pharmacologic therapy for atrial fibrillation (AF) in heart failure (HF) is an unmet need. In AF clinical trials, the standard primary endpoint of time to first symptomatic AF event (TTFSE) has several disadvantages, which could theoretically be overcome by measurement of AF-specific symptoms burden during an entire follow-up period.
Objectives: The authors sought to develop and validate a method of measuring symptom burden of AF in a HF population.
Efficacy of once-nightly sodium oxybate (FT218) on daytime symptoms in individuals with narcolepsy with or without concomitant alerting agent use: A post hoc analysis from the phase 3 REST-ON trial.
Sleep Med
December 2024
Avadel Pharmaceuticals, Chesterfield, MO, USA. Electronic address:
Article Synopsis
- Extended-release sodium oxybate (ON-SXB) showed significant improvements in narcolepsy symptoms in the REST-ON trial, which was a phase 3 study comparing it to a placebo.
- This analysis looked at the effectiveness of ON-SXB in patients both with and without the use of other alerting medications.
- Results indicated that ON-SXB led to substantial improvements in sleep latency, cataplexy episodes, and overall sleepiness, regardless of whether participants were using alerting agents.
Weight Loss With Once-nightly Sodium Oxybate for the Treatment of Narcolepsy: Analysis From the Phase III Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) Trial.
Clin Ther
October 2024
National Reference Centre for Orphan Diseases, Narcolepsy, Idiopathic Hypersomnia, Sleep Unit, Gui-de-Chauliac Hospital, CHU Montpellier, University of Montpellier, INM INSERM, Montpellier, France.
Purpose: Individuals with narcolepsy are more likely to be obese than the general population. Changes in weight-related measures with extended-release, once-nightly sodium oxybate (ON-SXB) and characteristics of participants with ≥5% weight loss were assessed in a Randomized study Evaluating the efficacy and SafeTy of a ONce nightly formulation of sodium oxybate (REST-ON) trial post hoc analysis.
Methods: REST-ON (NCT02720744) was a Phase III, double-blind, placebo-controlled, multicenter, randomized clinical trial.
Optimisation of medication reconciliation using queueing theory: a computer experiment.
Int J Clin Pharm
August 2024
Center for Healthcare Operations Improvement and Research (CHOIR), University of Twente, Enschede, The Netherlands.
Background: Medication reconciliation (MedRec) in hospitals is an important tool to enhance the continuity of care, but completing MedRec is challenging.
Aim: The aim of this study was to investigate whether queueing theory could be used to compare various interventions to optimise the MedRec process to ultimately reduce the number of patients discharged prior to MedRec being completed. Queueing theory, the mathematical study of waiting lines or queues, has not been previously applied in hospital pharmacies but enables comparisons without interfering with the baseline workflow.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!