| Autor: |
Weaver TE; University of Illinois at Chicago College of Nursing, Chicago, Illinois., Drake CL; Henry Ford Hospital Sleep Disorders and Research Center, Detroit, Michigan., Benes H; Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin, Germany.; Medical Center, University of Rostock, Rostock, Germany., Stern T; Advanced Respiratory and Sleep Medicine, PLLC, Huntersville, North Carolina., Maynard J; CTI Clinical Research Center, Cincinnati, Ohio., Thein SG; Pacific Research Network, Evolution Research Group, LLC, San Diego, California., Andry JM Sr; Sleep Therapy & Research Center, San Antonio, Texas., Hudson JD; FutureSearch Trials of Neurology LP, Austin, Texas., Chen D; Jazz Pharmaceuticals, Palo Alto, California., Carter LP; Jazz Pharmaceuticals, Palo Alto, California.; University of Arkansas for Medical Sciences, Little Rock, Arkansas., Bron M; Jazz Pharmaceuticals, Palo Alto, California., Lee L; Jazz Pharmaceuticals, Palo Alto, California., Black J; Jazz Pharmaceuticals, Palo Alto, California.; Stanford Center for Sleep Sciences and Medicine, Palo Alto, California., Bogan RK; SleepMed, Inc., Columbia, South Carolina; and.; University of South Carolina School of Medicine, Columbia, South Carolina. |
| Abstrakt: |
Rationale: Excessive daytime sleepiness in patients with obstructive sleep apnea is associated with substantial burden of illness. Objectives: To assess treatment effects of solriamfetol, a dopamine/norepinephrine reuptake inhibitor, on daily functioning, health-related quality of life, and work productivity in participants with obstructive sleep apnea and excessive daytime sleepiness as additional outcomes in a 12-week phase 3 trial (www.clinicaltrials.gov identifier NCT02348606). Methods: Participants ( N = 476) were randomized to solriamfetol 37.5, 75, 150, or 300 mg or to placebo. Outcome measures included the Functional Outcomes of Sleep Questionnaire short version, Work Productivity and Activity Impairment Questionnaire: Specific Health Problem, and 36-item Short Form Health Survey version 2. A mixed-effects model with repeated measures was used for comparisons with placebo. Results: Demographics, baseline disease characteristics, daily functioning, health-related quality of life, and work productivity were similar across groups. At Week 12, increased functioning and decreased impairment were observed with solriamfetol 150 and 300 mg (mean difference from placebo [95% confidence interval]) on the basis of Functional Outcomes of Sleep Questionnaire total score (1.22 [0.57 to 1.88] and 1.47 [0.80 to 2.13], respectively), overall work impairment (-11.67 [-19.66 to -3.69] and -11.75 [-19.93 to -3.57], respectively), activity impairment (-10.42 [-16.37 to -4.47] and -10.51 [-16.59 to -4.43], respectively), physical component summary (2.07 [0.42 to 3.72] and 1.91 [0.22 to 3.59], respectively), and mental component summary (150 mg only, 2.05 [0.14 to 3.96]). Common adverse events were headache, nausea, decreased appetite, and anxiety. Conclusions: Solriamfetol improved measures of functioning, quality of life, and work productivity in participants with obstructive sleep apnea and excessive daytime sleepiness. Safety was consistent with previous studies.Clinical trial registered with www.clinicaltrials.gov (NCT02348606). |
