Tirzepatide improves sleep apnea symptoms for adults with OSA plus obesity
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Key takeaways:
- Adults with obstructive sleep apnea had a greater reduction in events per hour at 1 year with tirzepatide vs. placebo.
- Tirzepatide reduced OSA symptoms for adults using and not using positive airway pressure.
Adults with moderate to severe obstructive sleep apnea and obesity had reductions in sleep apnea severity at 1 year with 10 mg or 15 mg of tirzepatide, according to topline results from two phase 3 trials.
As Healio previously reported, tirzepatide (Zepbound, Eli Lilly) was approved by the FDA for chronic weight management among adults with obesity in November 2023. Topline results from the SURMOUNT-OSA trials showed tirzepatide may have benefit beyond body weight reductions, as participants receiving the agent had greater reductions in apnea-hypopnea index (AHI) than placebo. AHI is a measure of the number of times a person with OSA has a restricted or complete block of airflow per hour of sleep.
The first SURMOUNT-OSA study enrolled adults with moderate to severe OSA and obesity who were not using positive airway pressure therapy. Participants were randomly assigned to once-weekly 10 mg or 15 mg tirzepatide or placebo for 1 year.
At 1 year, adults receiving tirzepatide had a mean AHI reduction of 27.4 events per hour from baseline compared with a mean AHI reduction of 4.8 events per hour for the placebo group according to the efficacy estimand. The tirzepatide group reduced their AHI from baseline by 55% compared with 5% for the placebo group. Adults receiving tirzepatide lost a mean 18.1% of their body weight from baseline to 1 year vs. a 1.3% reduction with placebo.
The second SURMOUNT-OSA study included adults with moderate to severe OSA plus obesity who continued positive airway pressure therapy during the study. In the efficacy estimand, adults receiving tirzepatide had a mean AHI reduction of 30.4 events per hour from baseline to 1 year compared with a mean reduction of 6 events per hour for the placebo group. The mean AHI reduction was 62.8% for the tirzepatide group vs. 6.4% for the placebo group. Those receiving tirzepatide lost a mean 20.1% of body weight from baseline to 1 year compared with a mean 2.3% weight loss with placebo.
The safety profile of tirzepatide in SURMOUNT-OSA was similar to what was previously reported in the SURMOUNT and SURPASS trials. The most common adverse events were gastrointestinal-related and were generally mild to moderate in severity. The most common adverse events in the first SURMOUNT-OSA study were diarrhea, nausea and vomiting, and the most common adverse events in the second study were diarrhea, nausea and constipation.
"Obstructive sleep apnea impacts 80 million adults in the U.S., with more than 20 million living with moderate to severe obstructive sleep apnea,” Jeff Emmick, MD, PhD, senior vice president of product development for Lilly, said in a press release. “However, 85% of obstructive sleep apnea cases go undiagnosed and therefore untreated. Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease."
Results from the SURMOUNT-OSA trial will be presented at the American Diabetes Association Scientific Sessions on June 21 at 3:45 p.m. EDT. Based on the results, Lilly said it plans to submit an application for approval with the FDA and other global regulatory agencies beginning mid-2024.
Perspective
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Over the past 30 years, an epidemic of obstructive sleep apnea has developed in parallel with the epidemic of obesity, most strikingly in the U.S. A causal relationship between weight gain and the prevalence and severity of OSA is well established. Independent of the degree of obesity, OSA is a risk factor for hypertension, cardiovascular disease and diabetes, and may cause further weight gain. OSA is positively associated with all-cause as well as CV mortality.
In population studies, more than 80% of adults with severe obesity are found to have OSA, but in the real world, OSA remains widely underdiagnosed. The standard treatment of OSA is overnight exposure to continuous positive airway pressure (CPAP) delivered by a device worn on the face, in principle for the entire night.
Adherence to nightly CPAP may be as challenging as adherence to dietary and behavioral recommendations for weight loss. The topline results of the SURMOUNT-OSA trials show that the combination of severe obesity with OSA may be effectively treated with weekly injections of tirzepatide. Relative to baseline, 1 year of tirzepatide promoted a nearly 20% reduction in body weight associated with a more than 50% reduction in the apnea-hypopnea index (–27.4 events/hour).
While studies of OSA severity after bariatric surgery have generally concluded that OSA was resolved or improved, the SURMOUNT-OSA trials are the first to report a similarly robust beneficial effect of pharmacologic weight loss.
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