Tirzepatide has been found to effectively treat both moderate-to-severe obstructive sleep apnea and obesity, in the SURMOUNT-OSA clinical trials.
"Patients with obstructive sleep apnea are sometimes unable or unwilling to adhere to PAP treatment, and PAP has not been shown to affect cardiovascular complications and death in obstructive sleep apnea; therefore, there is a need for additional treatment options," noted study investigators.
The 2 Phase 3, double-blind, randomized controlled trials were conducted over 52 weeks at 60 sites across 9 countries, according to data presented at the Scientific Sessions of the American Diabetes Association in Orlando, Florida, and published in the New England Journal of Medicine. The findings showed substantial reductions in apnea-hypopnea index (AHI) and body weight with tirzepatide.
The mean age of participants was 47.9 years in trial 1 and 51.7 years in trial 2. Most participants were male (67.1% in trial 1 and 72.3% in trial 2) and White (65.8% in trial 1 and 73.1% in trial 2). Mean body mass index was 39.1 in trial 1 and 38.7 in trial 2, with a mean AHI of 51.5 events per hour in trial 1 and 49.5 events per hour in trial 2.
Participants not receiving positive airway pressure (PAP) therapy (trial 1) and those receiving PAP therapy (trial 2) were randomly assigned to tirzepatide (10 mg or 15 mg) or a placebo. Primary outcomes focused on changes in apnea-hypopnea index, with key secondary endpoints including body weight, hypoxic burden, sleep impairment, high-sensitivity C-reactive protein, and systolic blood pressure.
In trial 1, tirzepatide reduced AHI by −25.3 events per 1 hour compared to −5.3 events per 1 hour with placebo, while trial 2 saw reductions of −29.3 events per 1 hour versus −5.5 events per 1 hour.
The percentage of participants who had a reduction in AHI of 50% or more at week 52 were significantly higher with tirzepatide compared to placebo (40.8% vs. 5.0% in trial 1; 50.2% vs. 5.3% in trial 2). Similarly, the percentages of participants who had an AHI of less than 5 events per hour or an AHI of 5 to 14 events per 1 hour of 10 or less at week 52 were higher with tirzepatide (24.0% vs. 3.3% in trial 1; 35.1% vs. 1.8% in trial 2).
Secondary outcomes included significant improvements in hypoxic burden, high-sensitivity C-reactive protein concentration, and systolic blood pressure. In a pooled analysis of trials 1 and 2, participants who received tirzepatide had significant reductions in PROMIS-SRI and PROMIS-SD T scores compared to placebo, indicating improvements in sleep-related impairment and sleep disturbance.
Adverse events included mild to moderate gastrointestinal issues, with 7.5% of participants reporting serious events, consistent across tirzepatide and placebo groups. Two cases of acute pancreatitis occurred in trial 2's tirzepatide group, with no reports of medullary thyroid cancer or deaths in either trial.
Trial limitations included the exclusion of participants without obesity, the lack of long-term cardiovascular outcome assessment, and the absence of an analysis of the intervention's effect on PAP treatment adherence. Additionally, the trials were not designed to investigate the potential effect of treatment interventions on adherence to PAP treatment.
A full list of disclosures can be found in the published research article.