Article ; Online: Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility.
Sleep & breathing = Schlaf & Atmung
2022 Volume 27, Issue 2, Page(s) 495–503
Abstract: Purpose: Preliminary studies have shown a significant decrease in severity of obstructive sleep apnea (OSA) with the use of a combination of atomoxetine and oxybutynin, with patients having moderate pharyngeal collapsibility during sleep more likely to ... ...
Abstract | Purpose: Preliminary studies have shown a significant decrease in severity of obstructive sleep apnea (OSA) with the use of a combination of atomoxetine and oxybutynin, with patients having moderate pharyngeal collapsibility during sleep more likely to respond. This study evaluated the efficacy and safety of AD036 (atomoxetine 80 mg and oxybutynin 5 mg) in the treatment of OSA. Methods: This trial was a phase 2, randomized, placebo-controlled crossover study comparing AD036, atomoxetine 80 mg alone, and placebo during three home sleep studies, each separated by about 1 week. The trial included patients with OSA and moderate pharyngeal collapsibility as defined by a higher proportion of hypopneas to apneas and mild oxygen desaturation. Results: Of 62 patients who were randomized, 60 were included in efficacy analyses. The apnea-hypopnea index (AHI) from a median (interquartile range) of 14.2 (5.4 to 22.3) events/h on placebo to 6.2 (2.8 to 13.6) with AD036 and 4.8 (1.4 to 11.6) with atomoxetine alone (p < .0001). Both drugs also decreased the oxygen desaturation index (ODI) and the hypoxic burden (p < .0001). AD036, but not atomoxetine alone, reduced the respiratory arousal index and improved ventilation at the respiratory arousal threshold (greater V Conclusion: AD036 significantly improved OSA severity in patients with moderate pharyngeal collapsibility. Atomoxetine may account for the majority of improvement in OSA severity, while the addition of oxybutynin may mitigate the disruptive effect of atomoxetine on sleep and further improve ventilation. Trial registration: Clinical trial registered with www. Clinicaltrials: gov (NCT04445688). |
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MeSH term(s) | Humans ; Atomoxetine Hydrochloride/pharmacology ; Atomoxetine Hydrochloride/therapeutic use ; Cross-Over Studies ; Sleep Apnea, Obstructive ; Sleep |
Chemical Substances | Atomoxetine Hydrochloride (57WVB6I2W0) ; oxybutynin (K9P6MC7092) |
Language | English |
Publishing date | 2022-05-13 |
Publishing country | Germany |
Document type | Randomized Controlled Trial ; Clinical Trial, Phase II ; Journal Article |
ZDB-ID | 1500381-4 |
ISSN | 1522-1709 ; 1520-9512 |
ISSN (online) | 1522-1709 |
ISSN | 1520-9512 |
DOI | 10.1007/s11325-022-02634-x |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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