Obstructive sleep apnea syndrome (OSAS) is a disorder characterized by repeated episodes of irregular breathing due to complete or partial obstructions of the upper airways, preventing those affected from enjoying a restful sleep. Now, a study led by researchers at the University of California, San Diego School of Medicine, along with international collaborators, has demonstrated the potential of tirzepatide – a next-generation drug used in the management of type 2 diabetes and obesity control – to become the first effective pharmacological therapy to treat obstructive sleep apnea.
“This study marks a significant milestone in the treatment of obstructive sleep apnea, offering a promising new therapeutic option that addresses both respiratory and metabolic complications,” said Dr. Atul Malhotra, senior author of the study, professor of medicine at the University of California San Diego School of Medicine and director of sleep medicine at UC San Diego Health.
OSAS can cause reduced blood oxygen levels and is associated with an increased risk of cardiovascular complications, such as hypertension and heart disease. Recent studies, also led by Malhotra, suggest that the number of patients with obstructive sleep apnea in the world is approaching 936 million. The results, published online June 21, 2024, in the New England Journal of Medicine, highlight the potential of this treatment to improve the quality of life for the millions affected by OSAS.
Reduced risk of cardiovascular disease and improved body weight
The research was carried out in two Phase III, randomized, double-blind, controlled trials, which included 469 participants diagnosed with obesity and moderate to severe OSA. Participants were recruited in nine countries, including the USA, Australia and Germany. Some of them used continuous positive airway pressure (CPAP) therapy, the most common treatment for sleep apnea. Patients received injections of 10 or 15 mg of the drug, or a placebo. The impact of tirzepatide was evaluated over 52 weeks.
The researchers found that tirzepatide caused a significant decrease in the number of breathing interruptions during sleep, a key indicator of the severity of obstructive sleep apnea. This improvement was much greater compared to participants who received a placebo (20 to 24 events per hour, a relative reduction in events of 48 to 56%). Additionally, some of the participants taking the medication reached a point where CPAP therapy might not be necessary.
A large body of data suggests that a drug therapy that targets both sleep apnea and obesity is more beneficial than treating each condition separately. In addition, drug therapy improved other aspects related to sleep apnea syndrome, such as reducing risk factors for cardiovascular diseases and improving body weight (an approximate 17% reduction compared to the placebo used in the trials). . The most common side effect reported by participants was mild stomach problems.
“Treating OSA meant using devices during sleep, like a CPAP machine. “This new pharmacological treatment offers a more accessible alternative for those who cannot tolerate or adhere to existing therapies.”
“Historically, treating OSA meant using devices during sleep, such as a CPAP machine, to relieve breathing difficulties and symptoms,” explains Malhotra. “However, its effectiveness depends on constant use. This new pharmacological treatment offers a more accessible alternative for those who cannot tolerate or adhere to existing therapies. We believe that combining CPAP therapy with weight loss will be optimal to improve cardiometabolic risk and symptoms. “Tirzepatide may also target specific underlying mechanisms of sleep apnea, which could lead to more personalized and effective treatment.”
Malhotra adds that having a pharmacological therapy for OSAS constitutes a significant advance in this area. “It means we can offer an innovative solution, offering hope and a new standard of care to provide relief to countless individuals and their families who have struggled with the limitations of existing treatments,” Malhotra said. “This advance opens the door to a new era in the management of obstructive sleep apnea for people diagnosed with obesity, potentially transforming how we approach and treat this widespread condition globally,” she concludes.
