ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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Reboxetine Plus Oxybutynin for Obstructed Sleep Apnea Treatment
Session Title
B14 - B014 PATHOPHYSIOLOGY, CARDIOVASCULAR DISEASE, AND COVID- WHAT'S HAPPENING IN SLEEP RESEARCH RIGHT NOW
Abstract
A1101 - Reboxetine Plus Oxybutynin for Obstructed Sleep Apnea Treatment
Author Block: E. Perger1, L. Taranto Montemurro2, D. Rosa1, S. Vicini1, M. Marconi1, L. Zanotti1, P. Meriggi3, A. Azarbarzin2, S. A. Sands2, A. Wellman2, C. Lombardi1, G. Parati1; 1Istituto Auxologico Italiano IRCCS, Milan, Italy, 2Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, United States, 3IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.
Introduction: In the last 40 years, attempts to treat obstructive sleep apnea (OSA) with medications have been disappointing. The recent discovery that a combination of noradrenergic and antimuscarinic drugs improved upper airway function during sleep and reduced OSA severity have revived interest in the pharmacological approach to treat OSA. While the previous trial evaluated the effect of the combination of atomoxetine and oxybutynin on OSA severity for a single night, in this study we evaluated the effect on OSA severity of reboxetine (a norepinephrine reuptake inhibitor similar to atomoxetine) plus oxybutynin after 1 week of therapy. The primary outcome was the reduction in the apnea-hypopnea index (AHI). Methods: We performed a randomized, placebo-controlled, double-blind, crossover trial comparing 4 mg reboxetine plus 5 mg oxybutynin (reb-oxy) to placebo administered orally before sleep in OSA subjects. Patients with a previous diagnosis of moderate-to-severe OSA performed a baseline in-lab polysomnography (PSG) to compare AHI and sleep characteristics after 7 nights of placebo and 7 nights of reb-oxy. A 3-minutes psychomotor vigilance test (PVT) and questionnaires on sleepiness were also administered after 7 days of treatment. A home-oximeter was provided for the entire at-home period to evaluate the frequency of oxygen desaturations (ODI) ≥ 4%. We also analyzed reb-oxy effects on specific OSA pathophysiological traits.Results: 16 subjects with (median [interquartile range]) age 57 [51-61] years and body mass index 30 [26-36] kg/m2 completed the study. AHI decreased from 49 [35-57] events/h at baseline to 18 [13-21]events/h (59% median reduction) on reb-oxy and to 39 [29-48]events/h (6% median reduction) on placebo (p<0.001). On reb-oxy, 81% of subjects reduced the AHI > 50% (13% on placebo) and 37% exhibited an AHI <15/h (6% on placebo). Average PVT decreased from 250 [239-312] msec on baseline to 223 [172-244] msec on reb-oxy versus 264 [217-284] msec on placebo (p<0.001). Subjective sleepiness was not different between treatment groups. Both at-home ODI and in-lab ODI improved on reb-oxy versus placebo (p<0.001 and p=0.021, respectively). Analysis of pathophysiological traits showed that reb-oxy increased muscle compensation and reduced arousal threshold compared to placebo (p= 0.012 and p=0.01, respectively). Conclusions: The administration of reboxetine plus oxybutynin before bedtime greatly decreased OSA severity and increased objective vigilance after 1-week of therapy. These results confirm and expand previous findings on the effect of noradrenergic and antimuscarinic agents on OSA and highlight potential possibilities for pharmaco-therapy to treat OSA.
Author Block: E. Perger1, L. Taranto Montemurro2, D. Rosa1, S. Vicini1, M. Marconi1, L. Zanotti1, P. Meriggi3, A. Azarbarzin2, S. A. Sands2, A. Wellman2, C. Lombardi1, G. Parati1; 1Istituto Auxologico Italiano IRCCS, Milan, Italy, 2Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, United States, 3IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy.
Introduction: In the last 40 years, attempts to treat obstructive sleep apnea (OSA) with medications have been disappointing. The recent discovery that a combination of noradrenergic and antimuscarinic drugs improved upper airway function during sleep and reduced OSA severity have revived interest in the pharmacological approach to treat OSA. While the previous trial evaluated the effect of the combination of atomoxetine and oxybutynin on OSA severity for a single night, in this study we evaluated the effect on OSA severity of reboxetine (a norepinephrine reuptake inhibitor similar to atomoxetine) plus oxybutynin after 1 week of therapy. The primary outcome was the reduction in the apnea-hypopnea index (AHI). Methods: We performed a randomized, placebo-controlled, double-blind, crossover trial comparing 4 mg reboxetine plus 5 mg oxybutynin (reb-oxy) to placebo administered orally before sleep in OSA subjects. Patients with a previous diagnosis of moderate-to-severe OSA performed a baseline in-lab polysomnography (PSG) to compare AHI and sleep characteristics after 7 nights of placebo and 7 nights of reb-oxy. A 3-minutes psychomotor vigilance test (PVT) and questionnaires on sleepiness were also administered after 7 days of treatment. A home-oximeter was provided for the entire at-home period to evaluate the frequency of oxygen desaturations (ODI) ≥ 4%. We also analyzed reb-oxy effects on specific OSA pathophysiological traits.Results: 16 subjects with (median [interquartile range]) age 57 [51-61] years and body mass index 30 [26-36] kg/m2 completed the study. AHI decreased from 49 [35-57] events/h at baseline to 18 [13-21]events/h (59% median reduction) on reb-oxy and to 39 [29-48]events/h (6% median reduction) on placebo (p<0.001). On reb-oxy, 81% of subjects reduced the AHI > 50% (13% on placebo) and 37% exhibited an AHI <15/h (6% on placebo). Average PVT decreased from 250 [239-312] msec on baseline to 223 [172-244] msec on reb-oxy versus 264 [217-284] msec on placebo (p<0.001). Subjective sleepiness was not different between treatment groups. Both at-home ODI and in-lab ODI improved on reb-oxy versus placebo (p<0.001 and p=0.021, respectively). Analysis of pathophysiological traits showed that reb-oxy increased muscle compensation and reduced arousal threshold compared to placebo (p= 0.012 and p=0.01, respectively). Conclusions: The administration of reboxetine plus oxybutynin before bedtime greatly decreased OSA severity and increased objective vigilance after 1-week of therapy. These results confirm and expand previous findings on the effect of noradrenergic and antimuscarinic agents on OSA and highlight potential possibilities for pharmaco-therapy to treat OSA.
