Reboxetine Plus Oxybutynin for OSA Treatment: A 1-Week, Randomized, Placebo-Controlled, Double-Blind Crossover Trial.
Adrenergic Uptake Inhibitors
/ therapeutic use
Cross-Over Studies
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Male
Mandelic Acids
/ therapeutic use
Middle Aged
Muscarinic Antagonists
/ therapeutic use
Polysomnography
Reboxetine
/ therapeutic use
Severity of Illness Index
Sleep Apnea, Obstructive
/ blood
Treatment Outcome
OSA
antimuscarinic and norepinephrine reuptake inhibitors
pharmacologic treatment
upper airway
vigilance
Journal
Chest
ISSN: 1931-3543
Titre abrégé: Chest
Pays: United States
ID NLM: 0231335
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
received:
19
03
2021
revised:
10
08
2021
accepted:
23
08
2021
pubmed:
21
9
2021
medline:
22
2
2022
entrez:
20
9
2021
Statut:
ppublish
Résumé
The recent discovery that a combination of noradrenergic and antimuscarinic drugs improved upper airway muscle function during sleep and reduced OSA severity has revitalized interest in pharmacologic therapies for OSA. Would 1 week of reboxetine plus oxybutynin (Reb-Oxy) be effective on OSA severity? A randomized, placebo-controlled, double-blind, crossover trial was performed comparing 4 mg reboxetine plus 5 mg oxybutynin (Reb-Oxy) vs placebo in patients with OSA. After a baseline in-laboratory polysomnogram (PSG), patients underwent PSGs after 7 nights of Reb-Oxy and 7 nights of placebo to compare apnea-hypopnea index (AHI), which was the primary outcome. Response rate was based on the percentage of subjects with a ≥ 50% reduction in AHI from baseline. Secondary outcomes included Epworth Sleepiness Scale (ESS) score and psychomotor vigilance test (PVT) values. Home oximetry evaluated overnight oxygen desaturation index (ODI) throughout treatment. Sixteen subjects aged 57 [51-61] years (median [interquartile range]) with a BMI of 30 [26-36] kg/m The administration of Reb-Oxy greatly decreased OSA severity and increased vigilance. These results highlight potential possibilities for pharmacologic treatment of OSA. ClinicalTrials.gov; No.: NCT04449133; URL: www.clinicaltrials.gov.
Sections du résumé
BACKGROUND
The recent discovery that a combination of noradrenergic and antimuscarinic drugs improved upper airway muscle function during sleep and reduced OSA severity has revitalized interest in pharmacologic therapies for OSA.
RESEARCH QUESTION
Would 1 week of reboxetine plus oxybutynin (Reb-Oxy) be effective on OSA severity?
STUDY DESIGN AND METHODS
A randomized, placebo-controlled, double-blind, crossover trial was performed comparing 4 mg reboxetine plus 5 mg oxybutynin (Reb-Oxy) vs placebo in patients with OSA. After a baseline in-laboratory polysomnogram (PSG), patients underwent PSGs after 7 nights of Reb-Oxy and 7 nights of placebo to compare apnea-hypopnea index (AHI), which was the primary outcome. Response rate was based on the percentage of subjects with a ≥ 50% reduction in AHI from baseline. Secondary outcomes included Epworth Sleepiness Scale (ESS) score and psychomotor vigilance test (PVT) values. Home oximetry evaluated overnight oxygen desaturation index (ODI) throughout treatment.
RESULTS
Sixteen subjects aged 57 [51-61] years (median [interquartile range]) with a BMI of 30 [26-36] kg/m
INTERPRETATION
The administration of Reb-Oxy greatly decreased OSA severity and increased vigilance. These results highlight potential possibilities for pharmacologic treatment of OSA.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov; No.: NCT04449133; URL: www.clinicaltrials.gov.
Identifiants
pubmed: 34543665
pii: S0012-3692(21)03861-7
doi: 10.1016/j.chest.2021.08.080
pii:
doi:
Substances chimiques
Adrenergic Uptake Inhibitors
0
Mandelic Acids
0
Muscarinic Antagonists
0
Reboxetine
947S0YZ36I
oxybutynin
K9P6MC7092
Banques de données
ClinicalTrials.gov
['NCT04449133']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
237-247Informations de copyright
Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.