An experimental drug called AD109 can reduce sleep breathing disturbances in people with obstructive sleep apnea who cannot or will not use standard positive airway pressure therapy, according to a study published in the American Journal of Respiratory and Critical Care Medicine.
The phase 3, randomized, double-blind trial involved 646 people with mild, moderate or severe apnea who were unable or unwilling to use PAP therapy. Over 26 weeks, participants received either AD109, a combination of the drugs aroxybutynin and atomoxetine, or a placebo.
Results of the Trial
By the end of the study, the frequency of apnea and hypopnea episodes in the group taking AD109 had fallen by about 44 percent from baseline, compared with an 18 percent drop in the placebo group. The drug also improved participants' blood oxygen saturation and reduced hypoxic burden, a measure of how much and how often oxygen levels drop during sleep. The researchers did not find a meaningful benefit for reducing daytime fatigue.
Side Effects Reported
Treatment came with side effects. About 21.2 percent of participants taking AD109 stopped the drug because of them, compared with 3.1 percent in the placebo group. The most common side effects were dry mouth, nausea, insomnia and difficulty urinating. The researchers reported no serious treatment-related adverse events.
What Is Obstructive Sleep Apnea
Obstructive sleep apnea is a common sleep disorder in which the muscles at the back of the throat relax too much during sleep, repeatedly blocking the airway and causing breathing to stop and start. Positive airway pressure therapy, delivered through a mask worn during sleep, is the standard treatment, but many patients find it uncomfortable or difficult to tolerate long-term, leaving a gap for alternative treatments such as AD109. The findings were published in the American Journal of Respiratory and Critical Care Medicine, a peer-reviewed journal covering research on lung and critical care disease.
Related Findings on Sleep Disorders
Scientists have previously found that a combination of insomnia and sleep apnea raises the risk of developing type 2 diabetes.
