Weight Loss Drug Tirzepatide Now Approved for Sleep Apnea in Adults With Obesity

Tirzepatide (Zepbound) has gained another approval, now as the first and only prescription drug for moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. The drug is recommended to be used alongside a reduced-calorie diet and increased physical activity.

Tirzepatide's approval for moderate-to-severe obstructive sleep apnea in adults with obesity was based on the results of the SURMOUNT-OSA trial.

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Tirzepatide was first approved for chronic weight management slightly more than a year ago. Since then, demand for the glucagon-like peptide 1 has skyrocketed, causing a temporary drug shortage, which was resolved.

The approval was based on the data from the SURMOUNT-OSA trial, a multicenter, randomized, double-blind parallel, placebo-master protocol comparing tirzepatide to placebo.

"Too often, OSA is brushed off as 'just snoring'—but it's far more than that," Julie Flygare, JD, president and CEO of Project Sleep, said in a statement.1 "It's important to understand OSA symptoms and know that treatments are available, including new options like Zepbound. We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes."

The results of the SURMOUNT-OSA trials were published in the New England Journal of Medicine. The phase 3 trials evaluated tirzepatide 10 mg or 15 mg compared with placebo in patients with or without positive airway pressure (PAP) therapy. In adults on PAP, tirzepatide resulted in 29 fewer breathing disruptions per hour vs 6 for placebo. For adults not on PAP, they had 25 fewer breathing disruptions per hour on tirzepatide vs 5 with placebo.

Adults on tirzepatide without PAP therapy lost an average of 45 pounds or 18% of their body weight. Those on tirzepatide with PAP therapy lost an average of 50 pounds or 20% of their body weight. In comparison, patients on placebo without PAP lost 4 pounds or 2% of body weight, and those on placebo with PAP lost 6 pounds or 2% of body weight.

"Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences," said Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA. "Zepbound is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity. Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges."

Tirzepatide is also being studied for heart failure with preserved ejection fraction. Data from the SUMMIT trial were recently presented at the American Heart Association Scientific Sessions, showing the drug reduced the risk of cardiovascular death or heart failure worsening by 38%.5

References

1. FDA approves Zepbound (tirzepatide) as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity. Eli Lilly. News release. December 20, 2024. Accessed December 20, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-zepboundr-tirzepatide-first-and-only-prescription

2. Joszt L. FDA approves diabetes drug tirzepatide for chronic weight management. AJMC. November 8, 2023. Accessed December 20, 2024. https://www.ajmc.com/view/fda-approves-diabetes-drug-tirzepatide-for-chronic-weight-management

3. McCormick B. 5 essential drugs currently facing shortages. AJMC. November 1, 2024. Accessed December 20, 2024. https://www.ajmc.com/view/5-essential-drugs-currently-facing-shortages

4. Melillo G. FDA approves Eli Lilly’s Tirzepatide for T2D. AJMC. May 13, 2022. Accessed December 20, 2024. https://www.ajmc.com/view/fda-approves-eli-lilly-s-tirzepatide-for-t2d

5. Caffrey M. For obesity and HFpEF, tirzepatide cuts risk of CV death or worsening HF by 38%. AJMC. November 16, 2024. Accessed December 20, 2024. https://www.ajmc.com/view/for-obesity-and-hfpef-tirzepatide-cuts-risk-of-cv-death-or-worsening-hf-by-38-