Title
Effects of Solriamfetol on Quality of Life Measures From a 12-Week Phase 3 Randomized Trial
Recommended Citation
Weaver TE, Drake CL, Benes H, Stern T, Maynard J, Thein SG, Andry JM, Sr., Hudson JD, Chen D, Carter LP, Bron M, Lee L, Black J, and Bogan RK. Effects of Solriamfetol on Quality of Life Measures From a 12-Week Phase 3 Randomized Trial. Ann Am Thorac Soc 2020.
Document Type
Article
Publication Date
4-30-2020
Publication Title
Ann Am Thorac Soc
Abstract
RATIONALE: Excessive daytime sleepiness in patients with obstructive sleep apnea is associated with substantial burden of illness.
OBJECTIVE: To assess solriamfetol, a dopamine/norepinephrine reuptake inhibitor, treatment effects 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.
METHODS: Participants (N=476) were randomized to solriamfetol 37.5, 75, 150, or 300 milligrams, or placebo. Outcome measures included Functional Outcomes of Sleep Questionnaire short version, Work Productivity and Activity Impairment questionnaire for Specific Health Problem, and 36-Item Short Form Health Survey version 2. A mixed-effects model with repeated measures was used for comparisons to 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 milligrams (mean difference from placebo [95% confidence interval]): Functional Outcomes of Sleep Questionnaire total score (1.22 [0.57, 1.88]) and (1.47 [0.80, 2.13], respectively), overall work impairment (-11.67 [-19.66, -3.69] and -11.75 [-19.93, -3.57], respectively) activity impairment (-10.42 [-16.37, -4.47] and -10.51 [-16.59, -4.43], respectively), physical component summary (2.07 [0.42, 3.72] and 1.91 [0.22, 3.59], respectively), and mental component summary (150 mg only: 2.05 [0.14, 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.
PubMed ID
32353246
ePublication
ePub ahead of print
Comments
Clinical trial registered with ClinicalTrials.gov (NCT02348606).