The U.S. Food and Drug Administration (FDA) approved lately Tirzepatide, produced by Eli Lilly, as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Tirzepatide may help adults with moderate-to-severe obstructive sleep apnea and obesity improve their sleep disorder. It should be used with a reduced-calorie diet and increased physical activity.
“Too often, OSA is brushed off as ‘just snoring’ — but it’s far more than that”, said Julie Flygare, J.D., president and CEO of Project Sleep. “It’s important to understand OSA symptoms and know that treatments are available, including new options like Tirzepatide. We hope this will spark more meaningful conversations between patients and healthcare providers and ultimately lead to better health outcomes”.
OSA is asleep-related breathing disorder characterized by complete or partial collapses of the upper airway during sleep, which can lead to pauses in breathing (apnea) or shallow breathing (hypopnea) and a potential decrease in oxygen saturation and/or waking from sleep. One of the hallmarks of OSA is snoring, but fatigue, excessive daytime sleepiness and disrupted sleep are also key symptoms, making this serious condition easily overlooked.
“Today, many cases of OSA go undiagnosed and untreated, leaving millions at risk for serious health consequences,” said Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA. “Tirzepatide 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.”
This approval was based on results from the SURMOUNT-OSA phase 3 clinical trials, which evaluated Tirzepatide (10 mg or 15 mg) for the treatment of moderate-to-severe OSA in adults with obesity, with and without positive airway pressure (PAP) therapy over the course of a year. Tirzepatide was about five times more effective than placebo in reducing breathing disruptions in adults not on PAP therapy, leading to 25 fewer breathing disruptions per hour with Tirzepatide and five with placebo. In adults on PAP therapy, Tirzepatide led to 29 fewer breathing disruptions per hour compared to six with placebo. After one year, 42% of adults on Tirzepatide and 50% of adults on Tirzepatide with PAP therapy experienced remission or mild,
non-symptomatic OSA, compared to 16% and 14% on placebo, respectively.
In addition to improved OSA symptoms, adults on Tirzepatide lost an average of 45 lbs (18%) of their body weight, while adults on Tirzepatide with PAP therapy lost an average of 50 lbs (20%) of their body weight, compared to 4 lbs (2%) and 6 lbs (2%) on placebo, respectively.
