Zepbound – Tirzepatide Approved for Sleep Apnea

The weight loss drug Zepbound has become the first prescription medication approved to treat obstructive sleep apnea. https://www.npr.org/2024/12/21/nx-s1-5236098/zepbound-sleep-apnea-approved-fda

The Food and Drug Administration just authorized the use of Zepbound, for adults with obesity and moderate to severe obstructive sleep apnea (OSA), a common condition in which overweight persons have difficulty breathing properly during sleep.  Sally Seymour, M.D.of the FDA’s Center for Drug Evaluation and Research states, “Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea. This is a major step forward for patients with obstructive sleep apnea.”

Obstructive sleep apnea (OSA) happens when a person’s upper airway becomes blocked, resulting in pauses in breathing while asleep. This often awakens the sufferer, who also tends to snore. Zepbound works by activating receptors of hormones secreted from the intestines to reduce appetite resulting in reduced food intake and weight loss. By reducing body weight, tirzepatide (Zepbound) improves OSA.

Zepbound’s FDA approval was given after Eli Lilly presented the results of two randomized, double-blind, placebo-controlled studies of 469 adults. One study enrolled participants who were using CPAP machines, the standard of care for Obstructive Sleep Apnea, and one study enrolled participants who did not use CPAP. The study participants in both studies received either 10 mg or 15 mg of Zepbound (Tirzepatide) or a placebo once weekly for 52 weeks. The participants who were treated with Zepbound had a significant weight loss compared with those receiving placebo. To assess the effect on sleep apnea a measure called  the apnea hypopnea index (AHI) was used which measures the change from baseline in how many times a person stops breathing (apnea) or breathes shallowly (hypopnea) per hour during sleep. After 52 weeks of treatment in both studies, those participants who received Zepbound showed a statistically significant and clinically meaningful reduction in events of apnea or hypopnea as measured by the Apnea Hypoxia Index (AHI). It was also shown that these participants achieved remission or improvements in their sleep apnea symptoms compared to those who got a placebo.  The study authors state that the improvement in Apnea Hypopnea Index was likely related to the weight loss that was accomplished using Zepbound.  

The studies upon which the FDA based its approval were completed and published in April 2024.

https://drsobo.com/zepbound-is-effective-for-weight-loss-and-sleep-apnea/

Published in The New England Journal of Medicine  this study demonstrates that tirzepatideTrusted Source — the main ingredient found in type 2 diabetes medication Mounjaro and weight loss treatment Zepbound — was a potential drug therapy for obstructive sleep apnea.

This phase 3 clinical trial found that tirzepatide helped to reduce symptom severity by almost two-thirds in adults with obesity and obstructive sleep apnea. In both studies, tirzepatide reportedly achieved a mean reduction of up to 62.8% on the apnea-hypopnea index (AHI)Trusted Source or about 30 fewer obstructive sleep apnea events restricting a person’s airflow per hour of sleep.

Additionally, the study found that of participants treated with tirzepatide at the highest dose, 43% in Study 1 and 51.5% in Study 2 met the criteria for obstructive sleep apnea “disease resolution.” Monique May, MD, a board certified family physician for Aeroflow Sleep, explained,“Obstructive sleep apnea is a sleep-related condition that results in the blockage or collapse of the upper airway, causing the sufferer to stop breathing several times a night. “The obstruction can be caused by a thick tongue, a thick neck, or excess fatty tissue in the upper airway, all of which are more common in [people with obesity.” https://www.medicalnewstoday.com/articles/zepbound-mounjaro-improves-sleep-apnea-symptoms

Previous studies show that obstructive sleep apnea impairs a person’s quality of lifeTrusted Source since it prevents them from getting a good night’s sleep. Mir Ali, MD, medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center says, “The thinking is (that) excess fat deposits in the airways and decreases the caliber of the airway, and it makes the tissue more floppy, so it’s easier to block the airway when sleeping because of the extra fat around the airway,”  Dr. Ali was not involved in the clinical trial.

Sleep apnea occurs when a person’s upper airway becomes blocked. It is much more prevalent among those who are overweight. Doctors have long recommended that maintaining a healthy weight is crucial for preventing or easing sleep apnea symptoms. A report on the problem of sleep apnea was published online by NPR with the title -Lose Weight Before Trying Other Sleep Apnea Treatments. This article asks, “So your snoring is driving your partner crazy. Does that mean you’re destined for one of those awkward-looking sleep apnea masks?” Rather than feel that they must resort to sleep apnea machines, losing weight may be the best treatment.

Dr. Molly Cooke, president of the American College of Physicians, speaks about new guidelines on treatment of sleep apnea.  The guidelines were published online in Annals of Internal Medicine. She says, “Losing weight gets rid of fat that blocks the windpipe.” And losing weight… “not only fix your sleep trouble, it would help your cholesterol, it would help your knees, your clothes would fit better and you would be a happier person.”  So, approval by the FDA is not surprising since Zepbound’s efficacy for helping the overweight reduce has been overwhelmingly established, and now with these positive sleep apnea study results Zepbound can be prescribed by physicians as an established, recognized treatment for their patients with  sleep apnea.

The approval of  a weight loss drug for another medical condition comes amid the increasing evidence that weight loss drugs and losing weight have many health benefits beyond the weight loss. 

Of particular interest is exploring their potential to treat addiction and certain cancers and the FDA approved the GLP-1 medication Wegovy (semaglutide) to be used to reduce the risk of strokes, heart attacks, and other cardiovascular problems in patients who are overweight.

Addictions: https://drsobo.com/glp-1-medications-for-reducing-alcohol-consumption/

Dr Lorenzo Leggio, clinical director of the National Institute of Drug Abuse explains that weight loss drugs …” also work on the brain. The mechanism in the brain that regulates overeating overlaps with those responsible for the development and maintenance of addiction, including alcohol disorder.”

Neuroscientist Alexandra G. DiFeliceantonio at Virginia Tech explains that after the first bite of food a release of the brain chemical dopamine occurs. “That dopamine essentially tells you, hey do that again! Take another bite.”  and you then want more. Dr DiFeliceantonio explains, dopamine in the brain’s motivation center is the learning signal for everything. “Not just for food. All addictive drugs increase dopamine. “

An extensive clinical review was done using electronic medical records aimed at evaluating whether a consistent effect may be seen between the use of GLP-1 medications and decreasing alcohol abuse disorder. https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00499-1/fulltext?dgcid=raven_jbs_aip_email

This scientific review consisted of six separate studies with a total of greater than 88,000 patient records of which nearly 44% were prescribed GLP-1 type medication.  A significant association was found between receiving these medications and lower alcohol consumption as well as fewer alcohol-related negative healthcare events. Also there is other evidence supporting the potential of GLP-1 RAs for the treatment of other reward system-related disorders. These documents decreased addictive behaviour relating to cocaine and nicotine, as well as for opioid use disorder. https://drsobo.com/semaglutide-may-protect-people-from-opioid-overdose/

Cardiac Disease 

https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or

John Sharretts, M.D., the director of the FDA’s Division of Diabetes, Lipid Disorders, and Obesity. In the FDA’s press release approving Wegovy’s (semaglutide) approval for heart disease prevention he states, “Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight. This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.” https://drsobo.com/reduce-risk-of-heart-problems-in-adults/

Wegovy’s efficacy and safety for this new indication was studied in a multi-centered placebo-controlled double-blind trial with over 17,600 study subjects. Study participants  received the usual standard-of-care medical treatments during the study as well as  healthy diet and lifestyle counseling. Wegovy significantly reduced the risk of major adverse cardiovascular events, (death, heart attack and stroke), for those  participants who received Wegovy compared to those who received placebo. https://drsobo.com/wegovy-semaglutide-approval-for-heart-failure/

Dementia/ Alzheimer’s Disease

https://drsobo.com/semaglutide-against-development-of-alzheimer’s-disease/

There is more evidence accumulating that semaglutide, the GLP-1 medication originally approved for diabetes, and subsequently for weight reduction, protects against neurodegeneration and neuroinflammation, https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.14313#alz14313-bib-0010 and therefore may be protective against the onset of Alzheimer’s Disease.

A study from the scientific journal Alzheimer’s and Dementia, the official publication of the Alzheimer’s Association, showed that semaglutide use over a three-year period lowered the risk of being diagnosed with Alzheimer’s Disease.This study was based on an analysis of the electronic health records (EHRs) of 116 million US patients who had no prior diagnosis of Alzheimer’s Disease at the time they were started on a semaglutide prescription.The conclusion of the study was that after a 3 year follow up semaglutide was associated with a 40-70% reduced risk of receiving a first time diagnosis of Alzheimer’s Disease. They observed the fact that semaglutide users had significantly lower Alzheimer’s related medications prescribed to them by the end of the study period, providing evidence to support the proposition that semaglutide may indeed delay or prevent Alzheimer’s Disease from developing.

Cancer  

Research published in the scientific journal JAMA Oncology showed that diabetics who took GLP-1 agonist medications had a lower risk of Colorectal cancer compared to other type 2 diabetics. https://jamanetwork.com/journals/jamaoncology/fullarticle/2812769

Reduced Risk Of Other Cancers – Obesity is a risk factor for a wide variety of cancers including breast, uterine, kidney, gallbladder, liver and pancreatic cancers as well as colorectal cancer.Approximately 4-8% of all cancers are obesity related. The NIH (National Institutes of Health) states, ”Weight-reducing strategies in obesity-associated cancers are important interventions as a key component of cancer care ” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9857053/#:~:text=Obesity%20has%20been%20linked%20to,cancers%20are%20attrib

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