Pharmaceutical maker Eli Lilly announced Wednesday that its obesity drug tirzepatide, or Zepbound, provides significant relief to overweight or obese people suffering from obstructive sleep apnea or episodes of respiratory arrest during sleep .
The findings, from two one-year clinical trials, could provide a new treatment option for some 20 million Americans diagnosed with moderate to severe obstructive sleep apnea. Most people with this condition do not realize they have it, according to the drug’s manufacturer. People with sleep apnea have trouble getting enough sleep and are at increased risk of high blood pressure, heart disease, diabetes, stroke and dementia.
The study results have not been published in a peer-reviewed medical journal. Eli Lilly only provided a summary of its results: Companies are required to announce results that could affect their stock prices as soon as they are obtained. Dr. Daniel M. Skovronsky, Eli Lilly’s chief scientific officer, said the company is still analyzing the data and will provide detailed results at the American Diabetes Association’s 84th Scientific Session in June .
But experts not affiliated with Eli Lilly or involved in its studies were encouraged by the summary.
“It’s great,” said Dr. Henry Klar Yaggi, director of the Yale Centers for Sleep Medicine in New Haven, Connecticut.
He added that the most common treatment, a CPAP machine that forces air into the airways and keeps them open during sleep, is effective. About 60 percent of patients who use continuous positive airway pressure continue to use it, he said.
Dr. Eric Landsness, a sleep medicine researcher at Washington University in St. Louis, said Lilly’s results were “phenomenal.”
They suggest, he said, that tirzepatide “is a great alternative for obese people who can’t use CPAP or who are on CPAP and want to improve its effect.”
He added that unlike current treatments that only treat the symptoms of sleep apnea, stopping breathing, tirzepatide addresses the underlying cause, namely blockages in the airways that prevent a person from to breathe.
Tirzepatide, sold under the brand name Zepbound, was approved by the Food and Drug Administration for weight loss in November. The agency had previously approved the diabetes drug under the name Mounjaro. Tirzepatide is part of the GLP-1 class of drugs that includes Ozempic and Wegovy, sold by Novo Nordisk.
Patients who participated in these Eli Lilly trials were overweight or obese and had moderate to severe obstructive sleep apnea, with moderate defined as stopping breathing at least 15 times per hour during sleep. The trials did not involve people with central sleep apnea, a type that occurs because the brain stops signaling the muscles that control breathing.
One of the Lilly studies involved about 200 obese people who were unable or unwilling to use a CPAP machine. Half were randomly assigned to tirzepatide, a weekly injection. The others received a placebo.
Those who received tirzepatide experienced an average of 27.4 fewer apnea events per hour, compared to an average reduction of 4.8 events per hour for placebo.
The other Lilly trial involved about 200 obese people who used a CPAP machine and were encouraged to continue using it except for assessing their apnea episodes. Those who took tirzepatide experienced an average of 30.4 fewer events per hour after one year of treatment, compared to an average reduction of six events per hour for participants who received a placebo.
In both studies, participants who took tirzepatide lost about 20 percent of their weight. Dr. Skovronsky of Eli Lilly attributed the results to the loss of fatty deposits in the tongue and airways.
Many obese people, Dr. Landsness explains, have fatty deposits in the tongue and back of the throat. The neck enlarges with fat that narrows the airway, and the tongue enlarges in all directions, “like blowing up a balloon,” he said. During sleep, the tongue obstructs the flow of oxygen, thus waking the person repeatedly.
Researchers hypothesized that losing weight would reduce episodes of obstructive sleep apnea. But before the advent of new drugs like tirzepatide, significant and permanent weight loss was virtually impossible for most obese people unless they underwent bariatric surgery.
Marishka Brown, director of the federally funded National Sleep Disorders Research Center, said it had been difficult to know how much of an effect losing weight would have on people with sleep apnea. .
“Sometimes sleep apnea goes away, but not always,” Dr. Brown said.
For this reason, she added, when asked whether weight loss was an effective treatment, “the research community has been a little cautious about saying yes or no.”
Now, with the new results, that hesitancy could change, the researchers said.
Of course, everyone in the study was eligible for tirzepatide anyway – it is approved for obese people, that is, those with a body mass index of at least 30, or for those having a body mass index of at least 27 and suffering from obesity. medical conditions.
But insurance companies don’t always pay for tirzepatide for weight loss. The drug’s list price is about $1,000 a month, but insurers pay much less. Eli Lilly sells the drug to people without insurance for $550 a month.
Dr. Skovronsky said Eli Lilly plans to submit an application to the FDA and drug regulatory agencies around the world requesting that tirzepatide be approved for the reduction of sleep apnea in obese or overweight people.
“The goal is for insurance to cover this,” Dr. Skovronsky said.
News Source : www.nytimes.com
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