Tirzepatide for Obstructive Sleep Apnea and Obesity | NEJM

Summary

Two phase 3 trials evaluated tirzepatide, a long-acting medication, as a treatment for obstructive sleep apnea (OSA) in adults with obesity. In these studies, 469 participants were randomly assigned tirzepatide or placebo for 52 weeks. Results showed that tirzepatide significantly reduced the apnea-hypopnea index, a key measure of OSA severity, more effectively than placebo. Weight loss and other secondary outcomes also favored tirzepatide. Common side effects were mild to moderate gastrointestinal issues. The trials suggest tirzepatide may be a promising treatment for OSA in obese adults.

Takeaways

• 🌍 Obstructive sleep apnea affects more than 900 million people worldwide.
• ⚖️ Excess adiposity (body fat) is a major reversible risk factor for obstructive sleep apnea.
• 💉 Tirzepatide, a long-acting agonist of GIP and GLP-1 receptors, has been shown to reduce body weight.
• 🔬 Two phase 3, multicenter, randomized, double-blind, controlled trials evaluated tirzepatide as a treatment for obstructive sleep apnea in adults with obesity.
• 👨‍⚕️ Trial 1 involved 469 adults with moderate-to-severe obstructive sleep apnea and obesity, who were not using positive airway pressure (PAP) therapy.
• 🩺 Trial 2 included adults who were already receiving PAP therapy.
• 📉 The primary outcome measured was the change in the apnea-hypopnea index (AHI) from baseline, indicating the frequency of apneas and hypopneas per hour of sleep.
• ✅ In Trial 1, after 52 weeks, the AHI decreased by 25 events per hour in the tirzepatide group, compared to only 5 events per hour in the placebo group.
• ⚖️ The key secondary outcomes, including percentage change in body weight, also favored tirzepatide over placebo.
• 🤒 The most common side effects with tirzepatide were gastrointestinal in nature, generally mild to moderate in severity.

Q & A

What is obstructive sleep apnea (OSA), and how prevalent is it globally?

Obstructive sleep apnea (OSA) is a condition characterized by repeated episodes of partial or complete blockage of the airway during sleep. It affects more than 900 million people worldwide.

What is a major reversible risk factor for obstructive sleep apnea?

Excess adiposity, or excess body fat, is a major reversible risk factor for obstructive sleep apnea.

What is tirzepatide, and how does it relate to weight reduction?

Tirzepatide is a long-acting agonist of the glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, which has been shown to reduce body weight.

What was the objective of the two trials involving tirzepatide?

The trials aimed to evaluate tirzepatide as a potential treatment for obstructive sleep apnea in adults with obesity.

How many adults participated in these trials, and what was the trial design?

A total of 469 adults with moderate-to-severe obstructive sleep apnea and obesity participated in these phase 3, multicenter, randomized, double-blind, controlled trials.

What were the primary differences between Trial 1 and Trial 2?

In Trial 1, participants were not receiving positive airway pressure (PAP) therapy, while Trial 2 enrolled participants who were receiving PAP therapy.

What was the primary endpoint in these trials?

The primary endpoint was the change in the apnea-hypopnea index (AHI), which measures the number of apneas and hypopneas during 1 hour of sleep, from baseline.

What were the results of Trial 1 regarding the apnea-hypopnea index (AHI) after 52 weeks?

In Trial 1, the apnea-hypopnea index decreased by a mean of 25 events per hour in the tirzepatide group compared to 5 events per hour in the placebo group after 52 weeks.

Did Trial 2 show similar results to Trial 1?

Yes, Trial 2 showed similar findings to Trial 1, with significant reductions in the apnea-hypopnea index in the tirzepatide group compared to the placebo group.

What were the most common adverse events associated with tirzepatide, and how severe were they?

The most common adverse events with tirzepatide were gastrointestinal in nature, and they were usually mild to moderate in severity.

What conclusions did the authors draw from these trials?

The authors concluded that in adults with moderate-to-severe obstructive sleep apnea and obesity, once-weekly treatment with tirzepatide led to significantly greater reductions in the apnea-hypopnea index at 52 weeks compared to placebo.