Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity
An erratum to this article was published (N Engl J Med, 17 Oct 2024 ↗)
Primary result · Change in AHI, trial 1 (no PAP)Result — go to the resultEstimated treatment difference −20.0 events per hour 95% CI −25.8 to −14.2Authors' conclusion
Among persons with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide reduced the AHI, body weight, hypoxic burden, hsCRP concentration, and systolic blood pressure and improved sleep-related patient-reported outcomes.
Study context
- Population
- Adults with moderate-to-severe obstructive sleep apnea and obesity; trial 1 not receiving positive airway pressure (PAP) at baseline, trial 2 receiving PAP at baselinerandomized 1:1
- Comparison
- Tirzepatide vs placebo
- Primary endpoint
- Change in AHI from baseline
- Follow-up
- Week 52
Methodological detailstwo trials, phase 3, double-blind, placebo-controlled
- Two trials
- Phase 3
- Double-blind
- Placebo-controlled
Primary result
Change in AHI, trial 1 (no PAP)
Estimated treatment difference
−20.0 events per hour
95% CI −25.8 to −14.2
P < 0.001
Change by group
Tirzepatide
−25.3
mean · 95% CI −29.3–-21.2 · events per hour
Placebo
−5.3
mean · 95% CI −9.4–-1.1 · events per hour
As reported in the abstract
Secondary outcomes
Mean, events per hour
| Outcome | Tirzepatide | Placebo | Estimated treatment difference (events per hour) (95% CI) | P value | |
|---|---|---|---|---|---|
| Change in AHI, trial 2 (on PAP) · week 52 | −29.3 (95% CI −33.2–-25.4) | −5.5 (95% CI −9.9–-1.2) | −23.8 (−29.6 to −17.9) | P < 0.001 | |
| −40−20020Difference, events per hour (linear scale) |
- Change in apnea-hypopnea index (AHI), trial 2 (on PAP): primary end point of trial 2
Key secondary end points (% change in AHI and body weight, hypoxic burden, sleep impairment and disturbance, high-sensitivity C-reactive protein (hsCRP), systolic BP)
- Significant improvements in all prespecified key secondary end points with tirzepatide vs placebo
- Multiplicity-controlled
Safety
- Most frequent adverse events with tirzepatide were gastrointestinal, mostly mild to moderate
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →