Researchers at the University of California, San Diego School of Medicine and international collaborators have led a world-leading study demonstrating the potential of tirzepatide, known to control type 2 diabetes, as the first effective drug therapy for apnea. obstructive sleep disorder (OSA), a sleeping disease. Related disorder characterized by repeated episodes of irregular breathing due to complete or partial blockage of the upper airways.
The results, published in the June 21, 2024, online edition of New England Journal of Medicinehighlight the treatment’s potential to improve the quality of life of millions of people around the world affected by OSA.
“This study marks an important milestone in the treatment of OSA and offers a promising new therapeutic option that addresses both respiratory and metabolic complications,” said Dr. Atul Malhotra, senior author of the study and professor of medicine at the School of San Diego. Diego from 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 randomized, double-blind, phase III controlled trials, the new study cohort involved 469 participants diagnosed with clinical obesity and living with moderate to severe OSA. They were recruited at 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 treatment for sleep apnea that uses a machine to keep the airway open during sleep, preventing interruptions in breathing. Patients were given 10 or 15 mg of the drug by injection or a placebo. The impact of tirzepatide was evaluated over 52 weeks.
The researchers found that tirzepatide led to a significant decrease in the number of breathing interruptions during sleep, a key indicator used to measure the severity of OSA. This improvement was much greater than that seen in participants who received a placebo. Importantly, some participants taking the medication reached a point where CPAP therapy might not be necessary. There is considerable data to suggest that drug therapy targeting both sleep apnea and obesity is beneficial rather than treating either condition separately.
In addition, drug therapy improved other aspects related to OSA, such as reducing cardiovascular disease risk factors and improving body weight. The most common side effect reported was mild stomach problems.
“Historically, OSA treatment involved using devices during sleep, such as a CPAP machine, to relieve breathing difficulties and symptoms,” Malhotra said. “However, its effectiveness depends on consistent use. This new pharmacological treatment offers a more accessible alternative for people who cannot tolerate or comply with existing therapies. We believe that the combination of 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 drug therapy for OSA represents a significant advance in the field.
“It means we can offer an innovative solution, which represents hope and a new standard of care to provide relief to countless people and their families who have struggled with the limitations of existing treatments,” Malhotra said. “This breakthrough opens the door to a new era in OSA treatment for people diagnosed with obesity, potentially transforming the way we approach and treat this widespread condition on a global scale.”
Next steps include conducting clinical trials to examine the long-term effects of tirzepatide.
Co-authors of the study include: Ronald Grunstein, University of Sydney; Ingo Fietze, University Hospital Berlin; Terri Weaver, University of Illinois 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.