Today, Eli Lilly and Company announced that the U.S. FDA has approved its blockbuster therapy Zepbound (tirzepatide) to improve snoring in obese patients with moderate to severe obstructive sleep apnea (OSA). Zepbound can help these patients improve sleep disorders, but they need to be combined with a low-calorie diet and increased physical activity. Trial results show that after one year of Zepbound treatment, up to 50% of patients no longer have symptoms related to OSA. According to the press release, Zepbound is the first prescription drug approved for the treatment of obese patients with moderate to severe OSA.

Frequent snoring may be a sign of OSA. This condition is caused by the complete or partial collapse of the patient's upper airway during sleep, resulting in airway obstruction, which may cause apnea or weakened breathing, and may be accompanied by decreased blood oxygen saturation or waking up during sleep. OSA can lead to serious cardiometabolic complications, such as hypertension, coronary artery disease, stroke, heart failure, atrial fibrillation, and type 2 diabetes. There has been little progress in the treatment of this disease over the past 40 years, and many patients need to use positive airway pressure (PAP) devices to maintain ventilation during sleep, but such treatments are limited in effectiveness and many patients find it difficult to adapt to the discomfort of wearing them.

The approval is based primarily on the results of the Phase 3 SURMOUNT-OSA clinical trial, which evaluated the effectiveness of Zepbound (10 mg or 15 mg) in treating obese patients with moderate to severe OSA, regardless of whether the patients were treated with a positive airway pressure device.

The analysis showed that for adults not using PAP therapy, Zepbound was five times more effective than placebo in reducing respiratory interruptions, with Zepbound reducing the number of respiratory interruptions per hour by 25, while placebo only reduced it by 5. In adults using PAP therapy, Zepbound reduced the number of respiratory interruptions per hour by 29, while placebo only reduced it by 6. After one year, 42% of adults treated with Zepbound achieved remission or mild, symptom-free OSA, compared with 50% of those also treated with PAP, and 16% and 14%, respectively, in the placebo group.

In addition to improving OSA symptoms, adults treated with Zepbound lost an average of 45 pounds (18%), compared with 50 pounds (20%) in those also treated with PAP, compared with 4 pounds (2%) and 6 pounds (2%) in the placebo group, respectively.

The overall safety profile of the drugs in the SURMOUNT-OSA study was similar to previous clinical trials. The most commonly reported adverse events were gastrointestinal related and were generally mild to moderate.

Zepbound is a dual GIP/GLP-1 receptor agonist that activates both GLP-1 and GIP receptor-mediated signaling pathways. GIP and GLP-1 are natural incretin hormones that regulate blood sugar. In November 2023, Zepbound was approved by the FDA for use in obese or overweight adult patients to lose weight and maintain a stable weight. This approval for the treatment of OSA patients is the second indication approved by Zepbound in the United States in more than a year.

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