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Reboxetine Plus Oxybutynin for OSA Treatment: A 1-Week, Randomized, Placebo-Controlled, Double-Blind Crossover Trial

Authors :
Elisa, Perger
Luigi, Taranto Montemurro
Debora, Rosa
Stefano, Vicini
Mariapaola, Marconi
Lucia, Zanotti
Paolo, Meriggi
Ali, Azarbarzin
Scott A, Sands
Andrew, Wellman
Carolina, Lombardi
Gianfranco, Parati
Source :
Chest. 161(1)
Publication Year :
2021

Abstract

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/mThe 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.

Details

ISSN :
19313543
Volume :
161
Issue :
1
Database :
OpenAIRE
Journal :
Chest
Accession number :
edsair.pmid..........81c52cb0ed741489a8d621cdc6987243