Atul Malhotra, MD: Tirzepatide for Obstructive Sleep Apnea and Obesity

With the results of the SURMOUNT-OSA trial demonstrating the benefit of tirzepatide (Zepbound) in obstructive sleep apnea (OSA) and obesity, the dual GIP/GLP-1 receptor agonist stands poised to usher in a new era of management for OSA.

“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 Atul Malhotra, MD, lead author of the study, professor of medicine at University of California San Diego School of Medicine and director of sleep medicine at UC San Diego Health.^1,2

Presented at the American Diabetes Association 84th Scientific Sessions, SURMOUNT-OSA included 2 substudies: Study 1 involved patients who could not or did not want to use positive airway pressure (PAP) therapy, while Study 2 included patients who were on and planned to continue PAP therapy. Both studies had the same primary outcome of interest, which was the change in the apnea-hypopnea index (AHI) from baseline to week 52.¹

A total of 234 individuals were included in study 1, with 114 receiving tirzepatide and 120 receiving placebo. At baseline, this cohort had a mean age of 47.9 years, 67.1% were male, 65.8% were White, the mean BMI was 39.1 kg/m2, and a mean AHI of 51.5 events per hour.¹

A total of 235 individuals were included in study 2, with 120 receiving tirzepatide and 115 receiving placebo. At baseline, this cohort had a mean age of 51.7 years, 72.3% were male, 73.1% were White, the mean BMI was 38.7 kg/m2, and a mean AHI of 49.5 events per hour.¹

Efficacy estimand of study 1 suggested use of tirzepatide was associated with a change in AHI of 27.4 events per hour (95% CI, −31.6 to −23.2) from baseline to week 52 compared to −4.8 events per hour (95% CI, −9.3 to −0.3) with placebo (estimated treatment difference, −22.5 events per hour; 95% CI, −28.7 to −16.4). Efficacy estimand of study 2 suggested use of tirzepatide was associated with a change in AHI of −30.4 events per hour (95% CI, −34.3 to −26.5) from baseline to week 52 compared to −6.0 events per hour (95% CI, −10.3 to −1.6) with placebo (estimated treatment difference, −24.4 events; 95% CI, −30.3 to −18.6).¹

Safety results indicated the observed safety profile from the trial was similar to that seen within the SURPASS and SURMOUNT programs. According to Eli Lilly and Company, the most common adverse events were gastrointestinal-related and generally mild to moderate in severity.^1,2,3

With interest in learning more about the study, secondary outcomes, and next steps in research to better to clarify the role of tirzepatide in management of OSA, check out our interview with Malhotra.

Disclosures of interest for Malhotra incldue the National Institutes of Health, Zoll, Jazz, Livanova, Eli Lilly, and ResMed.

References:

1. Malhotra A, Grunstein RR, Fietze I, et al. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. Presented at: American Diabetes Association (ADA) 84th Scientific Sessions. June 21 - 24, 2024. Orlando, FL.
2. Aquinde L. Study Identifies First Drug Therapy for Sleep Apnea. Newswise. June 21, 2024. Accessed June 21, 2024. https://www.newswise.com/articles/study-identifies-first-drug-therapy-for-sleep-apnea.
3. Eli Lilly and Company. Lilly’s tirzepatide reduced obstructive sleep apnea (OSA) severity, with up to 51.5% of participants meeting the criteria for disease resolution. Eli Lilly and Company.