SURMOUNT-OSA (trial 2)
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
28.0% female
72.0% male
N = 235
235 patients (65 female, 170 male).
Inclusion criteria: adult patients with moderate-to-severe obstructive sleep apnea and obesity who were 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=120 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=115 placebo (matching placebo once weekly for 52 weeks).
Primary outcome
Mean reduction in apnea-hypopnea index at week 52
29.3
5.5
29.3 events...
22.0 events...
14.7 events...
7.3 events...
0.0 events...
Tirzepatide
Placebo
Significant
increase ▲
Significantly greater reduction in mean apnea-hypopnea index at week 52 (29.3 events/hr vs. 5.5 events/hr; MD 23.8, 95% CI 17.9 to 29.6).
Secondary outcomes
Significantly greater reduction of ≥ 50% of apnea-hypopnea index at week 52 (72.4% vs. 23.3%; RR 3.1, 95% CI 2.1 to 4.5).
Significantly greater reduction in body weight at week 52 (19.6% vs. 2.3%; AD 17.3%, 95% CI 15.3 to 19.3).
Significantly greater reduction in sleep apnea-specific hypoxic burden at week 52 (103 min/hr vs. 41.7 min/hr; AD 61.3 min/hr, 95% CI 37.9 to 84.7).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with moderate-to-severe obstructive sleep apnea and obesity who were 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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