Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea

Autor: Kathleen Sarmiento, Lawrence Lee, Morgan Bron, Geert Mayer, Patrick J. Strollo, Jan Hedner, Patricia Chandler, Terri E. Weaver, Richard Schwab, Jean-Louis Pépin, Mansoor Ahmed, Atul Malhotra, Colin M. Shapiro, Nancy Foldvary-Schaefer, M. Baladi
Rok vydání: 2021
Předmět:
Excessive daytime sleepiness
narcolepsy
functional status
Psychology
Medicine
Lung
media_common
Sleep Apnea
Obstructive
Work productivity
work productivity
Scientific Investigations
Neurology
JZP-110
6.1 Pharmaceuticals
sleep disorders
medicine.symptom
Sleep Research
Sunosi
medicine.drug
Adult
Pulmonary and Respiratory Medicine
medicine.medical_specialty
Sleep Apnea
Phenylalanine
Clinical Trials and Supportive Activities
Clinical Sciences
Disorders of Excessive Somnolence
HRQoL
OSA
Quality of life (healthcare)
Norepinephrine reuptake inhibitor
Clinical Research
Decent Work and Economic Growth
Dopamine
Behavioral and Social Science
Humans
media_common.cataloged_instance
European union
Psychiatry
Narcolepsy
Other Medical and Health Sciences
Neurology & Neurosurgery
Obstructive
business.industry
Neurosciences
Evaluation of treatments and therapeutic interventions
medicine.disease
Brain Disorders
Obstructive sleep apnea
quality of life
Quality of Life
Carbamates
Neurology (clinical)
business
Zdroj: J Clin Sleep Med
Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, vol 17, iss 10
ISSN: 1550-9397
1550-9389
0234-8632
DOI: 10.5664/jcsm.9384
Popis: STUDY OBJECTIVES: Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, is approved in the United States and European Union for excessive daytime sleepiness in adults with narcolepsy (75–150 mg/day) or obstructive sleep apnea (OSA; 37.5–150 mg/day). In 12-week studies, solriamfetol was associated with improvements in quality of life in participants with narcolepsy or OSA. These analyses evaluated the long-term effects of solriamfetol on quality of life. METHODS: Participants with narcolepsy or OSA who completed previous solriamfetol studies were eligible. A 2-week titration was followed by a maintenance phase ≤ 50 weeks (stable doses: 75, 150, or 300 mg/day). Quality of life assessments included 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. Mean (standard deviation) changes from baseline to end of study were evaluated. Data were summarized descriptively. Adverse events were assessed. RESULTS: Safety population comprised 643 participants (417 OSA, 226 narcolepsy). Solriamfetol improved Functional Outcomes of Sleep Questionnaire short version Total scores (mean change [standard deviation], 3.7 [3.0]) and 36-Item Short Form Health Survey version 2 Physical and Mental Component Summary scores (3.1 [6.9] and 4.3 [8.4], respectively); improvements were sustained throughout treatment. On Work Productivity and Activity Impairment Questionnaire: Specific Health Problem, solriamfetol reduced (improved) % presenteeism, % overall work impairment, and % activity impairment by a minimum of 25%. Common adverse events (≥ 5%): headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection. CONCLUSIONS: Long-term solriamfetol treatment was associated with clinically meaningful, sustained improvements in functional status, work productivity, and quality of life for up to 52 weeks. Adverse events were similar between narcolepsy and OSA. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or OSA; Identifier: NCT02348632; URL: https://clinicaltrials.gov/ct2/show/NCT02348632 CITATION: Weaver TE, Pepin J-L, Schwab R, et al. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021;17(10):1995–2007.
Databáze: OpenAIRE
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