Drugmaker Eli Lilly said Wednesday that its obesity drug tirzepatide (Zepbound) provides significant relief for overweight or obese people with obstructive sleep apnea or symptoms of stopping breathing during sleep. Announced.
Results from two year-long clinical trials could provide a new treatment option for the approximately 20 million Americans diagnosed with moderate to severe obstructive sleep apnea. According to the drug company, most people with the disease do not know they have it. People with sleep apnea have difficulty getting enough sleep and face an increased risk of high blood pressure, heart disease, diabetes, stroke, and dementia.
The results of this study have not been published in a peer-reviewed medical journal. Eli Lilly provided only a summary of the results. Companies are required to announce such results as soon as they become available that could affect stock prices. Dr. Daniel M. Skovronski, Eli Lilly's chief scientific officer, said the company is still analyzing the data and will present detailed results at the American Diabetes Association's 84th Scientific Sessions in June. Then he said.
But experts not affiliated with Eli Lilly or involved in its research were encouraged by the overview.
“That's great,” said Dr. Henry Klar-Yaggi, director of the Yale University Sleep Medicine Center in New Haven, Conn.
He added that CPAP machines, the most common treatment, are effective at forcing air into the airways to keep them open while you sleep. He said about 60% of patients using continuous positive airway pressure continue to do so.
Dr. Eric Landsnes, a sleep medicine researcher at Washington University in St. Louis, said Lilly's results were “astounding.”
They suggest that tirzepatide is “a good alternative for people who are obese and cannot use CPAP, or for people who use CPAP and want to improve its effectiveness,” he said.
He added that unlike current treatments that only address the symptoms of sleep apnea or respiratory arrest, tirzepatide tracks the underlying cause of respiratory arrest, which is airway obstruction.
Tirzepatide, sold under the brand name Zepbound, was approved as a weight loss drug by the Food and Drug Administration in November. The agency had previously approved the diabetes drug under the name Mounjaro. Tilzepatide is part of his class of GLP-1 drugs, which includes Ozempic and Wegovy, sold by Novo Nordisk.
Patients in these Eli Lilly trials were overweight or obese and had moderate to severe obstructive sleep apnea. Moderate is defined as stopping breathing at least 15 times per hour during sleep. The study did not involve people with central sleep apnea, which occurs when the brain stops sending signals to the muscles that control breathing.
One of Lilly's studies looked at about 200 obese patients who were unable or unwilling to use a CPAP machine. Half were randomly assigned to tirzepatide (weekly injections). Others received a placebo.
Patients receiving tirzepatide experienced an average reduction of 27.4 apnea events per hour, compared to an average reduction of 4.8 events per hour for patients receiving tirzepatide.
In another Lilly trial, about 200 obese patients used a CPAP machine and were encouraged to continue using it except to evaluate for apnea episodes. Participants who took tirzepatide experienced an average reduction of 30.4 events per hour after one year of treatment, while participants who received a placebo experienced an average reduction of 6 events per hour.
In both studies, participants who took tirzepatide lost about 20 percent of their body weight. Eli Lilly's Dr. Skovronski attributed this result to a reduction in fatty deposits in the tongue and airways.
Dr. Landsnes explains that many obese people have fat deposits on their tongues and the back of their throats. The neck becomes enlarged with fat, narrowing the airways, and the tongue expands in all directions, “like blowing up a balloon.” During sleep, your tongue blocks the flow of oxygen, causing you to wake up many times.
Researchers thought that losing weight could reduce symptoms of obstructive sleep apnea. However, before new drugs like tirzepatide were introduced, significant and permanent weight loss was nearly impossible for most obese patients without undergoing bariatric surgery.
Marischka Brown, director of the federally funded National Center for Sleep Disorders Research, said it was difficult to know how much weight loss would affect people with sleep apnea.
“Sleep apnea can sometimes be cured, but it doesn't always go away,” Dr. Brown says.
So when asked if weight loss is an effective treatment, he added, “The research community is a little bit cautious about giving a yes or no answer.”
The new results could change that tentative view, the researchers said.
Of course, all study participants were eligible to receive tirzepatide anyway. It is approved for people with obesity, that is, those with a BMI of at least 30, or those with a BMI of at least 27, which is associated with obesity. medical condition.
However, insurance companies do not always pay for tirzepatide for weight loss. The drug's list price is about $1,000 a month, but insurance companies pay much less. Eli Lilly sells the drug to people without insurance for $550 a month.
Dr. Skovronski said Eli Lilly plans to submit an application to the FDA and drug regulatory agencies around the world seeking approval of tirzepatide for the relief of sleep apnea in people who are obese or overweight.
“The goal is to have insurance cover it,” Dr. Skovronsky said.