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Published on: December 6, 2016
Effect of oxybutynin and reboxetine on obstructive sleep apnea: a randomized, placebo-controlled, double-blind,
Mathieu Berger1,2, Geoffroy Solelhac1, Nicola A Marchi1
1Center for Investigation and Research in Sleep, Department of Medicine, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Study Objectives:
Although recent investigations combining noradrenergic and antimuscarinic drugs have shown promising short-term results to treat obstructive sleep apnea (OSA), the mid-term effect and optimal dosage remain uncertain. The present study aimed to evaluate the effect of 1 week of 5 mg oxybutynin and 6 mg reboxetine (oxy-reb) on OSA versus placebo.
Methods:
We performed a randomized, placebo-controlled, double-blind, crossover trial comparing the effect of 1 week of oxy-reb versus 1 week of placebo on OSA severity. At-home polysomnography was performed at baseline and after each week of intervention.
Results:
Fifteen participants (male 66.7%) aged 59 [44-62] years (median [interquartile range]) with a mean body mass index of 33.1 ± 6.6 kg/m2 were included. No significant difference in apnea-hypopnea index (AHI) was observed between conditions (estimated marginal means [95% confidence interval] at baseline: 39.7 [28.5-55.3]; oxy-reb: 34.5 [22.7-52.3]; placebo: 37.9 [27.1-52.9]; p = 0.652), but oxy-reb improved average oxygen desaturation (p = 0.016) and hypoxic burden (p = 0.011) and lowered sleep efficiency (p = 0.019) and rapid eye movement sleep (p = 0.002). Moreover, participants reported reduced sleep quality during the week of oxy-reb compared to the week of placebo (4.7 [3.5; 5.9] vs. 6.5 [5.5; 7.5] on a 0-10 visual analogic scale, respectively; p = 0.001). No significant differences in sleepiness, vigilance, and fatigue were observed. No serious adverse events occurred.
Conclusions:
Administration of oxybutynin 5 mg and reboxetine 6 mg did not improve OSA severity assessed by AHI, but did alter sleep architecture and sleep quality. Reduced average oxygen desaturation and hypoxic burden were also observed.
Clinical Trial:
ClinicalTrials.gov, https://clinicaltrials.gov, NCT04394143.
Insights
This study found that a combination of oxybutynin and reboxetine did not improve obstructive sleep apnea (OSA) severity but did reduce oxygen desaturation and worsen sleep quality. Further research is needed for OSA treatment options.
Area of Science:
- Sleep Medicine
- Pharmacology
- Respiratory Medicine
Background:
- Obstructive sleep apnea (OSA) is a common sleep disorder.
- Current treatments for OSA have limitations, and novel pharmacological approaches are being investigated.
- Combining noradrenergic and antimuscarinic drugs has shown short-term promise for OSA, but mid-term effects and optimal dosages are unclear.
Purpose of the Study:
- To evaluate the mid-term effect of a 1-week combination of oxybutynin (5 mg) and reboxetine (6 mg) on obstructive sleep apnea (OSA) severity compared to placebo.
- To assess the impact of this drug combination on sleep architecture, oxygen saturation, and patient-reported outcomes.
Main Methods:
- A randomized, placebo-controlled, double-blind, crossover trial was conducted.
- Fifteen participants with OSA underwent at-home polysomnography at baseline and after each 1-week intervention period (oxybutynin-reboxetine or placebo).
- Apnea-hypopnea index (AHI), oxygen desaturation, sleep efficiency, sleep stages, and subjective sleep quality were assessed.
Main Results:
- The oxybutynin-reboxetine combination did not significantly reduce the apnea-hypopnea index (AHI) compared to placebo (p = 0.652).
- However, the drug combination significantly improved average oxygen desaturation (p = 0.016) and reduced hypoxic burden (p = 0.011).
- Sleep efficiency was lowered (p = 0.019), REM sleep was reduced (p = 0.002), and participants reported poorer sleep quality (p = 0.001) with oxybutynin-reboxetine.
Conclusions:
- The combination of oxybutynin 5 mg and reboxetine 6 mg for 1 week did not improve OSA severity as measured by AHI.
- The drug combination altered sleep architecture, reduced sleep quality, and improved oxygenation parameters.
- Further investigation is warranted to understand the clinical implications and potential of this drug combination in OSA management.
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