First drug therapy for sleep apnea identified in study

Researchers from the University of California San Diego School of Medicine and international collaborators have conducted an advanced global study demonstrating the potential of tirzepatide, known to manage type 2 diabetes, as the first effective drug treatment for Obstructive sleep apnea (OSA), a sleeping disease. related disorder characterized by repeated episodes of irregular breathing due to complete or partial blockage of the upper airway.

The findings, published in the June 21, 2024 online edition of the New England Journal of Medicine, highlight the treatment's potential to improve the quality of life for millions of people worldwide affected by OSA.

“This study marks an important milestone in the treatment of OSA, providing a promising new therapeutic option that addresses both respiratory and metabolic complications,” said senior study author Atul Malhotra, MD, professor of medicine. at the San Diego School of the University of California. of Medicine and director of sleep medicine at UC San Diego Health.

OSA can lead to reduced blood oxygen levels and may also be 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 OSA patients worldwide is approaching 936 million.

Conducted in two phase III randomized, double-blind controlled trials, the new study cohort involved 469 participants diagnosed with clinical obesity and living with moderate to severe OSA. They were recruited from sites in nine different countries, including the United States, Australia and Germany. Participants did or did not use continuous positive airway pressure (CPAP) therapy, the most common sleep apnea treatment that uses a machine to keep the airway open during sleep, preventing interruptions in breathing. Patients received either 10 or 15 mg of the drug by injection or a placebo. The impact of tirzepatide was evaluated over 52 weeks.

Researchers found that tirzepatide led to a significant decrease in the number of pauses in breathing during sleep, a key indicator used to measure the severity of OSA. This improvement was much greater than that observed in participants who received a placebo. It is important to note that some participants who took the medication reached a point where CPAP treatment may no longer be necessary. There is ample evidence to suggest that drug treatment targeting both sleep apnea and obesity is beneficial rather than treating either condition alone.

Additionally, drug treatment improved other aspects related to OSA, such as reduction of cardiovascular disease risk factors and improvement in body weight. The most commonly reported side effect was mild stomach problems.

“Historically, treating OSA meant using devices during sleep, such as a CPAP machine, to relieve breathing difficulties and symptoms,” Malhotra said. “However, its effectiveness relies on consistent use. This new drug treatment offers a more accessible alternative for people who cannot tolerate or adhere to existing therapies. We believe that combining CPAP therapy with weight loss will be optimal for improve cardiometabolic risk and symptoms Tirzepatide may also target specific underlying mechanisms of sleep apnea, potentially leading to more personalized and effective treatment.

Malhotra adds that having a drug treatment for OSA represents a significant advancement in the field.

“This means we can offer an innovative, hopeful solution 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 advancement opens the door to a new era of OSA management for people diagnosed with obesity, potentially transforming how we approach and treat this globally ubiquitous disease.” »

Next steps include conducting clinical trials to examine the longer-term effects of tirzepatide.

Co-authors of the study include: Ronald Grunstein, University of Sydney; Ingo Fietze, Berlin University Hospital; Terri Weaver, University of Illinois at Chicago; Susan Redline, Ali Azarbarzin and Scott Sands, Harvard Medical School; Richard Schwab, University of Pennsylvania; and Julia Dunn, Sujatro Chakladar, Mathijs Bunck and Josef Bednarik, Eli Lilly and Company.

Financial support for the study came, in part, from Eli Lilly and Company.