SURMOUNT-OSA (trial 1)
Trial question
What is the role of tirzepatide in patients with moderate-to-severe obstructive sleep apnea and obesity?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 234
234 patients (77 female, 157 male).
Inclusion criteria: adult patients with moderate-to-severe obstructive sleep apnea and obesity who were not receiving positive airway pressure at baseline.
Key exclusion criteria: T1DM or T2DM; participant-reported change in body weight of > 5 kg in the 3 months before screening; planned surgery for sleep apnea or obesity; diagnosis of central or mixed sleep apnea; major craniofacial abnormalities.
Interventions
N=114 tirzepatide (initiated at 2.5 mg SC once weekly and increased by 2.5 mg every 4 weeks to a maintenance dose of 10-15 mg once weekly, and continued for a total of 52 weeks).
N=120 placebo (matching placebo once weekly for 52 weeks).
Primary outcome
Mean reduction in apnea-hypopnea index at week 52
25.3
5.3
25.3 events...
19.0 events...
12.7 events...
6.3 events...
0.0 events...
Tirzepatide
Placebo
Significant
increase ▲
Significantly greater reduction in mean apnea-hypopnea index at week 52 (25.3 events/hr vs. 5.3 events/hr; MD 20, 95% CI 14.2 to 25.8).
Secondary outcomes
Significantly greater reduction of ≥ 50% of apnea-hypopnea index at week 52 (61.2% vs. 19%; RR 3.3, 95% CI 2.1 to 5.1).
Significantly greater reduction in body weight at week 52 (17.7% vs. 1.6%; AD 16.1%, 95% CI 14.2 to 18).
Significantly greater reduction in sleep apnea-specific hypoxic burden at week 52 (95.2 min/hr vs. 25.1 min/hr; AD 70.1 min/hr, 95% CI 49.3 to 90.9).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with moderate-to-severe obstructive sleep apnea and obesity who were not receiving positive airway pressure at baseline, tirzepatide was superior to placebo with respect to mean reduction in apnea-hypopnea index at week 52.
Reference
Atul Malhotra, Ronald R Grunstein, Ingo Fietze et al. Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. N Engl J Med. 2024 Oct 3;391(13):1193-1205.
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