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DOI: 10.1055/s-0045-1807558
Tirzepatide Improved Sleep Disordered Breathing in Adults with Obstructive Sleep Apnea with Obesity: Results from SURMOUNT-OSA Trials.
How efficacious and safe was tirzepatide in treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity?
Methodology: SURMOUNT-OSA (NCT05412004) is a master protocol guiding 2 randomized, placebo-controlled trials investigating the efficacy and safety of tirzepatide to placebo in adults living with moderate-to-severe OSA with obesity. Under a master protocol, the two trials were composed of trial 1: included participants who were unable or unwilling to use positive airway pressure (PAP) therapy, and trial 2: included participants who were and planned to stay on PAP therapy during the 52 week duration of the trials. Overall, in the two trials 469 participants were randomized in a 1:1 ratio to receive tirzepatide maximum tolerated dose (MTD) 10 or 15 mg once weekly, or placebo.
Results: At baseline, mean apnea-hypopnea index (AHI) was 50.1 events/hour and mean body mass index was 38.8 kg/m^2. Tirzepatide-treatment was associated with mean AHI reductions from baseline to week 52 of 27.4 (55.0%) and 30.4 (62.8%) events per hour compared to 4.8 (5.0%) and 6.0 (6.4%) events per hour for placebo in trial 1 and trial 2, respectively. Moreover, tirzepatide-treatment was associated with to a mean body weight reduction from baseline of 18.1% and 20.1%, compared to 1.3% and 2.3% for placebo, in trial 1 and trial 2, respectively. The overall safety profile of tirzepatide in SURMOUNT-OSA studies was similar to previously reported SURMOUNT trials. The most commonly reported adverse events in SURMOUNT-OSA trials were gastrointestinal-related and generally mild to moderate in severity and occurred during dose escalation.
Conclusion: Tirzepatide-treatment occurred with clinically meaningfully improved sleep disordered breathing compared to placebo in adults with moderate-to-severe OSA with obesity, with consistent findings across the two trials.
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Publication History
Article published online:
28 May 2025
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