- The obesity and diabetes medication tirzepatide (Mounjaro, Zepbound) reduced obstructive sleep apnea events by as much as two-thirds in new clinical trials.
- The abstract (but not the complete study) for the SURMOUNT-OSA trial was just published in the New England Journal of Medicine.
- Obstructive sleep apnea, a condition in which an individual may stop breathing periodically while they sleep, does not currently have any approved pharmacological treatments.
Results from new clinical trials indicate that the groundbreaking obesity and diabetes medication tirzepatide also improved symptoms of obstructive sleep apnea (OSA)
Tirzepatide, sold under the brand names Mounjaro and Zepbound, is part of the class of GLP-1 drugs, similar to Ozempic, that work by mimicking a hormone in the body that slows down digestion and causes feelings of satiety, resulting significant weight loss. The drug is already FDA-approved for the treatment of obesity and diabetes.
Researchers have also been investigating how the drug, and other GLP-1 drugs, could be used to treat obesity-related comorbidities, like cardiovascular disease and heart failure. Now, in a pair of clinical trials, researchers investigated whether tirzepatide could improve symptoms of obstructive sleep apnea (OSA), a condition in which individuals may stop breathing while they sleep.
After two years of trials, involving more than 400 adults with OPS, researchers have published the abstract of their findings in the New England Journal of Medicine. The study was sponsored by Eli Lilly, the maker of Mounjaro and Zepbound.
Tirzepatide reduced symptoms of OPS by nearly two-thirds, or 66% in some adults, while a placebo only resulted in a reduction of 5%.
“These results are really incredible,” said Caroline Apovian, MD, a Professor of Medicine at Harvard Medical School and the co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital. Apovian wasn’t affiliated with the study.
Oliver Sum-Ping, MD, a Clinical Associate Professor of Psychiatry and Sleep Medicine at Stanford Medicine who wasn’t affiliated with the research told Healthline, “The results suggest substantial potential for the role of these medications for at least mitigating OSA.”
The SURMOUNT-OSA trial was a multi-center, randomized, double-blind, placebo-controlled trial conducted with 469 patients, all of whom had OSA. The first study included only patients who had OSA and obesity, but were not yet using positive airway pressure (PAP) therapy, which is considered the “gold standard” for OSA care. In the second trial, the patients had the same characteristics but were already using PAP therapy.
Patients taking tirzepatide were matched at a 1:1 ratio with patients taking a placebo.
Both trials were conducted for 52 weeks to compare the baseline number of apnea events (instances in which the patient stopped breathing while sleeping) against the number after 52 weeks.
In the first trial, the baseline number of events was 51.5 per hour. At the end of the trial, patients taking tirzepatide experienced 36 per hour, a reduction of nearly 30%. The placebo group only experienced about five fewer events per hour, less than a 10% reduction.
Results were even more compelling in the second trial, where patients were already utilizing PAP therapy.
The baseline number of events in the trial was 49.5, but dropped to 20.2 in the tirzepatide group after 52 weeks — a reduction of nearly two-thirds. Similar to the first trial, the placebo group only experienced about five less.
Sum-Ping told Healthline that although only the abstract has been published so far, the research shows a lot of promise.
“I think there is considerable potential for this drug (and class) as a treatment for obstructive sleep apnea. There is significant need for new treatment options in this space and the results in this study are very strong,” he said.
Despite the compelling results, he told Healthline, “The patients still seemed to have a non-trivial degree of sleep apnea remaining.” Suggesting that treatment with these medications does not entirely eliminate sleep apnea.
Secondary endpoints from the trials include weight loss, improved blood pressure, and self-reported sleep disturbances. The abstract does not include the specifics for these endpoints, only stating that there were “significant improvements.”
Eli Lilly previously disclosed in a press release, that they expected patients using tirzepatide to lose between 18-20% of their body weight. Those taking a placebo were only expected to lose 1-2% of their body weight.
The abstract does not note any participants who dropped out of the trial due to side effects. However, the most commonly reported events by patients were mild-to-moderate gastrointestinal issues.
Nausea, vomiting, and diarrhea are commonly associated with GLP1 drugs, but other more serious complications can occur.
In 2023 the FDA updated the requirements for some GLP1 drugs to include a warning for ileus, intestinal blockage, a rare, but potentially-fatal complication.
Learn more about how to get GLP-1 medications like Mounjaro and Zepbound from vetted and trusted online sources here:
OSA is the most common sleep-related breathing disorder. It occurs when an individual’s airway is obstructed while they sleep, resulting in restricted or occluded airflow. In some cases changes in the vocal cords or apnea events may happen throughout the night.
There are currently no pharmacological treatments approved for OSA by the FDA. That means there’s a lot of potential for tirzepatide if it reaches FDA approval for the condition.
The “gold standard” for OSA treatment is CPAP therapy, which requires a patient to wear a
While CPAP therapy is effective, it can be cumbersome and difficult for some users who don’t want to wear an air mask when they sleep, or are bothered by the noise of the machine.
“CPAP works great for a lot of patients, but it is not a good solution for everybody…There are a lot of people with significant sleep apnea for whom there is no adequate treatment option. This study is exciting because it provides a reason for optimism for many of these patients,” said Sum-Ping.
In clinical trials, tirzepatide reduced sleep apnea events by as much as two-thirds or about 66% over the course of 52 weeks in patients with obstructive sleep apnea. Patients taking a placebo experienced a reduction of less than 10%.
The results were reported in an abstract in the New England Journal of Medicine. The trial included more than 400 participants with obstructive sleep apnea.
The current “gold standard” of sleep apnea treatment is a CPAP machine, which some patients may find too cumbersome or uncomfortable to use. This study suggests there may be drugs that are soon available for OSA.
There is no FDA-approved pharmacological treatment for sleep apnea. Experts say the results are promising, but more research is needed.
