Sleep Apnea Oxygen Mask Equipment
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Two separate Phase III clinical trials have shown that the diabetes and obesity drug tirzepatide led to significant decreases in the in the number of breathing interruptions during sleep of patients with obstructive sleep apnea (OSA), setting it up as potentially the first medication to treat the disorder.

The results of the two separate Phase III, double-blind, randomized, controlled trials involving adults with moderate-to-severe obstructive sleep apnea and obesity are published in the New England Journal of Medicine.

“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 lead author Atul Malhotra, MD, a professor of medicine at University of California (UC) San Diego School of Medicine and director of sleep medicine at UC San Diego Health.

Malhotra has also led studies to determine the prevalence of OSA and suggests the number of people worldwide suffering from the sleep disorder to be more than 900 million. OSA is characterized by recurrent partial or complete obstruction of a person’s upper airway leading to reduced or obstructed breathing during sleep. It has been linked with a range of other health conditions, notably heart conditions such as hypertension and heart disease.

The two Phase III trials enrolled a total of 469 participants diagnosed with clinical obesity and moderate to severe OSA. The studies were conducted across clinical sites in nine different countries. The two studies were delineated by either those patients who used continuous positive airway pressure (CPAP) therapy, the most common current treatment for the condition and those who did not use it. Enrolled patients received either 10 mg or 15 mg of tirzepatide by injection or placebo. The impact of the drug was evaluated after 52 weeks.

Results showed that the drug led to significant decreases in the number of breath interruptions during sleep, a key measure of the severity of OSA and some who took the drug reached a point where using CPAP as a therapy might no longer be necessary. The data also showed improvements in hypoxic burden, patient-reported sleep impairment and disturbance, high-sensitivity C-reactive protein (hsCRP) concentration, and systolic blood pressure.

“Historically, treating OSA meant using devices during sleep, like a CPAP machine, to alleviate breathing difficulties and symptoms,” Malhotra noted. “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.”

He added that the combination of CPAP and weight loss is optimal for improving cardiometabolic risk factors in patients and that tirzepatide can be used to target the specific underlying health issues caused by OSA to help create personalized treatment plans. Having a drug to effectively treat sleep apnea would mark a significant advancement 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,” said Malhotra. “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.”

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