Eli Lilly, the manufacturer of Zepbound, announced on Friday that the Food and Drug Administration had extended the medication’s approval to treat obstructive sleep apnea in obese adults. About 39 million adults in the US suffer from the illness, and this decision makes it the first medication treatment for it.
The FDA has already approved Zepbound, which has the same active component as Lilly’s diabetic medication Mounjaro, to treat individuals who are obese or overweight.
More insurance companies who have been hesitant to pay for the pricey weight loss medications may be convinced to do so by the wider approval.
According to a statement from Julie Flygare, president and CEO of Project Sleep, a nonprofit organization that promotes sleep health, OSA [obstructive sleep apnea] is significantly more than just snoring.
Blockage of the upper airway during sleep results in obstructive sleep apnea, which stops airflow all night long. A person is frequently startled awake while gasping for air, which leads to fragmented, restless sleep.One of the main causes of sleep apnea is obesity, which can constrict the airway.It can cause diabetes, heart arrhythmias, heart failure, stroke, and brain damage if left untreated.
According to a research of over 4,000 participants that was presented at the annual conference of the American Academy of Neurology in April, those who suffer from sleep apnea may also be more susceptible to cognitive or memory issues.
Evidence that GLP-1 medications enhance general health in addition to weight loss is supported by the approval. Novo Nordisk’s Wegovy was authorized by the FDA in March to lower the risk of heart disease. To find out if GLP-1s can help delay renal disease, stop addiction, or prevent Alzheimer’s, more research is being done.
Whether Zepbound helps persons with sleep apnea via helping them lose weight or because its active ingredient, tirzepatide, is doing anything else in the body is unknown. Two trials including obese men and women with moderate to severe sleep apnea served as the basis for the approval.
People who used Zepbound in Lilly’s sleep apnea study lost an average of 20% of their body weight.
People with sleep apnea typically experience a reduction in symptoms when they lose weight, according to Dr. Susan Spratt, an endocrinologist and senior medical director for the Population Health Management Office at Duke Health in North Carolina.
However, we’ve found that it’s difficult to lose weight without taking medicine, Spratt added.
Other sleep apnea treatments
Many sleep apnea sufferers remain undetected and untreated.
Positive airway pressure (PAP) machines, which gently blow air into the airway to prevent it from collapsing, are currently used to treat obstructive sleep apnea. The most often prescribed type of PAP is continuous positive airway pressure, or CPAP.
According to Dr. Timothy Morgenthaler, a pulmonologist and sleep medicine specialist at the Mayo Clinic, CPAP machines are often affordable, operate rapidly, and have few side effects.
However, users have been irritated in recent years after Phillips Respironics, a major maker of CPAPs, recalled millions of its devices in 2021 after discovering that its noise-canceling foam might degrade and be ingested.
According to Morgenthaler, some people have trouble with CPAP machines and turn to less effective alternatives like surgery, which can be expensive, or oral devices.
According to him, this has made space for increased interest in medication alternatives like GLP-1s.
People may be able to get rid of an inconvenient machine or use a weekly injection like Zepbound in conjunction with other treatments for better results.
For many individuals, losing weight alone can dramatically lessen the severity of OSA; however, tirzepatide may have other helpful mechanisms, according to Morgenthaler. Its high cost, adverse effects, and requirement for long-term management plans—all of which are currently being researched—are obstacles, too.
How well does Zepbound work for sleep apnea?
Researchers at Lilly investigated if Zepbound was more effective than a placebo at lowering the average number of times an individual stopped breathing completely or partially during sleep, on an hourly basis. In the second investigation, PAP machines were utilized, but not in the first.
Those who were not using PAP devices experienced an average decrease of 25 events per hour after 52 weeks, while those who were receiving a placebo experienced an average decrease of five events per hour.
Zepbound resulted in an average reduction of 29 occurrences per hour in those who did use PAP equipment, while the placebo group experienced an average reduction of six events per hour.
According to Lilly, 42% of people taking Zepbound and 50% of adults taking Zepbound in conjunction with PAP therapy had remission or decreased symptoms after a year.
Although a head-to-head trial would be necessary to ascertain whether Zepbound is better than PAP, Spratt said the approval is an amazing step forward.
According to her, gaining weight raises the chance of sleep apnea.
Other therapies are still required, according to Morgenthaler, who also noted that opening the airway by itself does not alleviate insomnia, which affects 30 to 40 percent of individuals with sleep apnea.
“We must understand that managing OSA involves more than just maintaining an open airway while we sleep,” he stated.
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