In patients with obstructive sleep apnea (OSA), a combination treatment comprising reboxetine and oxybutynin significantly reduced severity of the condition and increased alertness, according to study findings published in Chest.
The study included 16 patients (median age, 57 years; body mass index, 30) with OSA who were randomly assigned 1:1 to receive either a combination regimen consisting of 4 mg reboxetine plus 5 mg oxybutynin or placebo. Following an in-lab polysomnogram at baseline, patients performed additional polysomnograms after 7 nights on their assigned treatment.
Researchers used polysomnogram data to compare the treatment arms in terms of the apnea-hypopnea index (AHI). The response rate was calculated based on the proportion of patients who experienced a reduction of 50% or more in AHI from baseline to follow-up. The researchers also assessed patients using the Epworth Sleepiness Scale (ESS) and psychomotor vigilance test (PVT).
Treatment with the reboxetine and oxybutynin combination significantly lowered AHI from 49 events per hour at baseline to 18 events per hour at follow-up, while treatment with placebo was associated with a reduction in AHI to 39 events per hour at follow-up (P <.001). The response rate to treatment was also significantly higher in the combination arm (81% vs 13%; P <.001).
The ESS score did not significantly reduce throughout treatment; however, PVT median reaction time decreased from 250 ms at baseline to 223 ms in the combination group vs 264 ms in the placebo group (P <.001). Data from home oximetry showed acute and sustained improvement in oxygen desaturation index in the reboxetine and oxybutynin group vs the placebo arm.
Limitations of this study include its short follow-up period and small sample size, which may limit the applicability of the findings to a broader patient population.
The researchers wrote that their “results provide strong pilot data for the design of larger and longer studies testing these drugs as a pharmacological therapy for OSA patients.”
Disclosure: This clinical trial was supported by Apnimed. Multiple authors declared affiliations with the pharmaceutical industry. Please refer to the original article for a full list of disclosures.
Perger E, Montemurro LT, Rosa D, et al. Reboxetine plus oxybutynin for obstructed sleep apnea treatment A 1-week randomized, placebo-controlled, double-blind crossover trial. Chest. Published online September 17, 2021. doi:10.1016/j.chest.2021.08.080