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Tirzepatide reduced symptoms of obstructive sleep apnea (OSA) and improved multiple cardiometabolic markers for adults with obesity and OSA, according to new data from the SURMOUNT-OSA clinical trial.¹

Specifically, researchers reported that adults who received tirzepatide had greater reductions in apnea-hypopnea index (AHI) events per hour compared to those who received placebo. This reduction was observed for adults using positive airway pressure (PAP) therapy and those who did not use PAP therapy.¹

The findings were presented at the American Diabetes Association’s (ADA) 84th Scientific Sessions, June 21-24, in Orlando, Florida, and simultaneously published in The New England Journal of Medicine.

Obesity is the most significant risk factor for OSA, however, traditional OSA medications (eg, continuous PAP [CPAP] devices) do not address obesity. A treatment that targets both OSA and obesity is needed, according to investigators. Therefore, they conducted the SURMOUNT-OSA trial to investigate the safety and efficacy of tirzepatide for OSA and obesity.¹

The trial consisted of 2 phase 3, double-blind, randomized controlled trials that enrolled adults with moderate-to-severe OSA and obesity. The first trial included participants who were not receiving treatment with PAP at baseline, and the second trial consisted of those who did receive PAP therapy at baseline. Participants were randomly assigned 1:1 to receive either the maximum tolerated doses of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks, according to the study abstract.¹

The primary endpoint was the change in AHI (the number of apneas and hypopneas during 1 hour of sleep) from baseline. Key secondary endpoints included the percent change in AHI and body weight, changes in hypoxic burden, patient-reported sleep impairment and disturbance, high-sensitivity C-reactive protein (hsCRP) concentration, and systolic blood pressure.¹

Findings

At baseline, the mean AHI was 51.5 events per hour in trial 1 and 49.5 events per hour in trial 2, and the mean body mass index was 39.1 kg/m² and 38.7 kg/m², respectively, according to the abstract.¹

In trial 1, the mean change in AHI at week 52 was −25.3 events per hour (95% CI −29.3 to −21.2) with tirzepatide and −5.3 events per hour (95% CI −9.4 to −1.1) with placebo, for an estimated treatment difference of −20.0 events per hour (95% CI −25.8 to −14.2) (P < .001).¹

In trial 2, the mean change in AHI at week 52 was −29.3 events per hour (95% CI −33.2 to −25.4) with tirzepatide and −5.5 events per hour (95% CI −9.9 to −1.2) with placebo, for an estimated treatment difference of −23.8 events per hour (95% CI −29.6 to −17.9) (P < .001).¹

Investigators observed significant improvements with tirzepatide as compared with placebo in the measurements for all prespecified key secondary endpoints. The most frequently reported adverse events among participants in the tirzepatide group were moderate-to-severe gastrointestinal-related conditions.¹

“The results of the study have demonstrated the ability of tirzepatide to address both obesity and sleep apnea, offering an effective and comprehensive treatment solution,” presenting author Atul Malhotra, MD, professor of medicine, University of California San Diego School of Medicine, director of sleep medicine, UC San Diego Health, said in an ADA press release. “Its potential to be used alongside or independently of CPAP could revolutionize how we manage these interconnected conditions. These findings show the potential for the first highly effective drug treatment for sleep apnea.”²

References:

1. Malhotra A, Grunstein RR, Fietze I, et al. Tirzepatide for the treatment of obstructive sleep apnea and obesity. N Engl J Med. Published online June 21, 2024. doi:10.1056/NEJMoa2404881
2. Use of tirzepatide shown to improve sleep apnea and cardiovascular outcomes. News release. American Diabetes Association. June 21, 2024. Accessed June 24, 2024. https://diabetes.org/newsroom/press-releases/use-tirzepatide-shown-improve-sleep-apnea-and-cardiovascular-outcomes