The FDA has approved Zepbound (tirzepatide) for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity. This approval stems from the phase 3 SURMOUNT-OSA study, which demonstrated significant reductions in the apnea-hypopnea index (AHI) and body weight compared to placebo, both in patients using and not using positive airway pressure therapy.
Key Points:
- The SURMOUNT-OSA trial included two distinct patient groups (n=469 total): those not on PAP therapy (n=234) and those using PAP therapy (n=235). Eligible participants had an AHI ≥15 events/hour and BMI ≥30kg/m2.
- Zepbound demonstrated superior AHI reduction versus placebo: -20 events/hour difference in non-PAP users and -23.8 events/hour difference in PAP users (P <.001 for both groups).
- Clinical remission or mild nonsymptomatic OSA was achieved in 42.2% of non-PAP users and 50.2% of PAP users treated with Zepbound, compared to 15.9% and 14.3% with placebo, respectively.
- Treatment resulted in significant weight reduction: -16.1% difference from placebo in non-PAP users and -17.3% in PAP users (P <.001).
- Common adverse events included diarrhea, nausea, vomiting, and constipation.
“Zepbound is the first medication that significantly improves moderate to severe OSA and aids in long-term weight loss in adults with obesity. Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges.”
– Patrik Jonsson, Executive Vice President, and President of Lilly Cardiometabolic Health and Lilly USA
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