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Lilly’s weight-loss drug reduces sleep apnea severity in late-stage studies

On Wednesday, Eli Lilly, the company that makes the obesity medication tirzepatide (also known as Zepbound), said that it significantly helped overweight or obese individuals who experience obstructive Sleep Apnea, where breathing stops during sleep.

Findings from two year-long clinical trials could present a fresh treatment possibility for around 20 million Americans diagnosed with moderate to severe Obstructive Sleep Apnea. Many with the condition are unaware of it, notes the drug manufacturer. Sleep apnea sufferers often battle sleep deficiency and are at higher risk for conditions like high blood pressure, heart disease, diabetes, strokes, and dementia.

An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, U.S., December 11, 2023. 
Brendan McDermid | Reuters

The study’s results haven’t been published in a peer-reviewed medical journal yet. Eli Lilly shared only a summary of its findings, as companies must promptly disclose such information that could impact their stock value. Dr. Daniel M. Skovronsky, Eli Lilly’s chief scientific officer, mentioned that the company is still scrutinizing the data and intends to present comprehensive results at the American Diabetes Association’s 84th Scientific Sessions in June.

However, independent experts, not associated with Eli Lilly or its research, found the summary promising.

“That’s fantastic,” remarked Dr. Henry Klar Yaggi, who serves as the director of the Yale Centers for Sleep Medicine in New Haven, Connecticut.

He further explained that the most prevalent treatment involves using a CPAP machine, which maintains an open airway by delivering air pressure during sleep and is effective. He noted that approximately 60 percent of patients who use continuous positive airway pressure continue to adhere to it.

Dr. Eric Landsness, a sleep medicine researcher at Washington University in St. Louis, described the Lilly findings as “remarkable.”

He indicated that the findings imply tirzepatide “offers a valuable option for individuals struggling with obesity who either cannot use CPAP or are seeking to enhance its effectiveness.”

He further explained that while existing treatments primarily tackle the symptoms of sleep apnea, such as breathing pauses, tirzepatide targets the root cause—the airway blockages that lead to breathing cessation.

Zepbound, also known as tirzepatide, received approval from the Food and Drug Administration for weight loss in November. Previously, the agency approved the drug for diabetes under the name Mounjaro. Tirzepatide belongs to the GLP-1 drug class, which includes medications like Ozempic and Wegovy, marketed by Novo Nordisk.

The participants in these Eli Lilly trials were individuals who were overweight or obese and were diagnosed with moderate to severe obstructive sleep apnea. In this context, moderate means experiencing breathing interruptions of at least 15 times per hour during sleep. It’s important to note that the trials did not include individuals with central sleep apnea, which is a type where breathing stops because the brain fails to signal the muscles responsible for breathing.

In one of the Lilly studies, approximately 200 individuals with obesity, who either could not or chose not to use a CPAP machine, participated. They were randomly divided into two groups: one receiving tirzepatide, administered as a weekly injection, and the other receiving a placebo.

Participants who received tirzepatide experienced an average decrease of 27.4 apnea events per hour, whereas those who received the placebo had an average reduction of 4.8 events per hour.

In the second Lilly trial, approximately 200 obese individuals using a CPAP machine were advised to maintain its use except during assessments of their apnea episodes. Among those who received tirzepatide, there was an average decrease of 30.4 events per hour after a year of treatment, while participants receiving the placebo experienced an average reduction of six events per hour.

In both trials, individuals who received tirzepatide experienced a weight loss of approximately 20 percent. Dr. Skovronsky from Eli Lilly attributed these results to the reduction of fat deposits in the tongue and airway.

Dr. Landsness clarified that numerous individuals with obesity tend to accumulate fat in the tongue and the rear of the throat. As fat accumulates in the neck, it enlarges, narrowing the airway. Additionally, he described how the tongue enlarges in various directions, likening it to inflating a balloon. This enlargement of the tongue and obstruction of the airway disrupt the flow of oxygen during sleep, causing frequent awakenings.

Researchers previously speculated that weight loss could decrease episodes of obstructive sleep apnea. However, prior to the emergence of new drugs like tirzepatide, achieving substantial and enduring weight loss was nearly unattainable for the majority of individuals with obesity unless they underwent bariatric surgery.

Marishka Brown, the director of the federally-funded National Center on Sleep Disorders Research, remarked that it had been challenging to determine the extent to which weight loss would impact individuals with sleep apnea.

“Sleep apnea sometimes resolves, but it’s not guaranteed,” Dr. Brown said.

For this reason, she explained, when questioned about the effectiveness of weight loss as a treatment, “the research community has been somewhat hesitant to give a definitive yes or no.”

Now, researchers suggest that with the emergence of these new results, such hesitance may change.

Certainly, all participants in the study were already eligible for tirzepatide regardless. The medication is approved for individuals with obesity, defined as having a body mass index (BMI) of at least 30, or for those with a BMI of at least 27 along with obesity-related medical conditions.

However, insurance coverage for tirzepatide for weight loss isn’t always guaranteed. While the drug’s retail price is approximately $1,000 per month, insurers typically cover a significantly lower amount. For individuals without insurance, Eli Lilly offers the drug for $550 per month.

Dr. Skovronsky mentioned that Eli Lilly intended to file an application with the FDA and other drug regulatory bodies worldwide, seeking approval for tirzepatide to be used in reducing sleep apnea among individuals with obesity or overweight status.

The post Lilly’s weight-loss drug reduces sleep apnea severity in late-stage studies first appeared on Business d'Or.



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