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Groundbreaking Study Unveils First Drug Therapy for Sleep Apnea

A novel drug initially developed to manage diabetes shows promising potential as a treatment for obstructive sleep apnea (OSA), significantly improving sleep quality and overall health for patients with obesity. Researchers at the University of California San Diego School of Medicine, in collaboration with international partners, spearheaded a comprehensive study that explores the effectiveness of tirzepatide, a drug known for its role in managing type 2 diabetes, in treating OSA. This sleep disorder is marked by repeated episodes of irregular breathing due to the partial or complete blockage of the upper airway.

The study's findings, published in the June 21, 2024, online edition of the New England Journal of Medicine, suggest that tirzepatide could become the first effective drug therapy for OSA, potentially improving the quality of life for millions of individuals worldwide who suffer from this condition.

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

OSA can lead to reduced oxygen levels in the blood and is associated with a higher risk of cardiovascular issues, including hypertension and heart disease. Recent research led by Malhotra estimates that nearly 936 million people globally are affected by OSA.

The study involved 469 participants diagnosed with clinical obesity and moderate-to-severe OSA, recruited from nine countries, including the U.S., Australia, and Germany. Participants were either using or not using continuous positive airway pressure (CPAP) therapy, the most common OSA treatment. CPAP therapy involves a machine that keeps the airway open during sleep, preventing breathing interruptions. Participants received either 10 or 15 mg of tirzepatide via injection or a placebo, and the effects of the drug were monitored over 52 weeks.

Researchers found that tirzepatide led to a significant reduction in the number of breathing interruptions during sleep, a crucial indicator of OSA severity. This improvement was substantially greater than in participants who received the placebo. Notably, some participants taking tirzepatide reached a point where CPAP therapy might no longer be necessary. This underscores the benefit of a treatment that addresses both sleep apnea and obesity rather than treating each condition separately.

Moreover, the drug therapy improved other aspects related to OSA, such as reducing cardiovascular disease risk factors and aiding in weight loss. The most common side effect reported was mild stomach issues.

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

Malhotra emphasized that introducing a drug therapy for OSA represents a significant leap forward in the field.

“It means we can offer an innovative solution, signifying 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,” he said. “This breakthrough opens the door to a new era of OSA management for people diagnosed with obesity, potentially transforming how we approach and treat this pervasive condition on a global scale.”

Future research steps include conducting clinical trials to examine the long-term effects of tirzepatide, ensuring its efficacy and safety as a treatment for OSA. This study heralds a promising shift in how we understand and treat sleep apnea, offering a beacon of hope for millions worldwide.