Discover the groundbreaking news as the FDA has officially approved Zepbound, a revolutionary treatment for sleep apnea! In this YouTube Shorts video, we explore how this innovative therapy could transform the lives of millions suffering from this common sleep disorder. With classic Hormozi-style subtitles displayed in the lower third, our clear American voice narrator breaks down the key points you need to know about Zepbound's efficacy and safety.
Join the conversation on how this approval could reshape sleep health! Don't forget to like and share this video to spread awareness about sleep apnea solutions!
FDA Approves Zepbound for Sleep Apnea
On Friday, the US Food and Drug Administration (FDA) approved Zepbound, the first prescription medication for obstructive sleep apnea (OSA). This weight-loss drug belongs to the GLP-1 receptor agonists class, which also includes Ozempic. It is specifically approved for treating moderate to severe cases of sleep apnea in individuals with obesity and should be used alongside a reduced-calorie diet and increased physical activity, as stated by the drugmaker, Eli Lilly.
Dr. Sally Seymour, director of the FDA’s Division of Pulmonology, Allergy, and Critical Care, emphasized the significance of this approval for OSA patients.
OSA impacts approximately 30 million people in the US and is closely linked to obesity, according to the American Academy of Sleep Medicine. The condition is characterized by interruptions in breathing during sleep due to blocked airflow and is associated with increased risks of heart and brain issues.
Patrik Jonsson, president of Lilly Cardiometabolic Health, highlighted that many cases of OSA remain undiagnosed and untreated, posing serious health risks. Symptoms often include snoring, gasping during sleep, and excessive daytime sleepiness. Jonsson pointed out that nearly half of the participants in Lilly’s clinical trials experienced such improvement that they no longer exhibited symptoms of OSA.
Zepbound previously received approval in November 2023 for weight loss in individuals with obesity or those who are overweight with related health conditions. While the new FDA approval does not expand eligibility beyond those with obesity, it may facilitate insurance coverage under Medicare for those with obstructive sleep apnea, as the policy currently does not cover obesity medications if they are prescribed solely for weight loss.
Without insurance, Zepbound costs about $1,060 monthly, but Eli Lilly provides discounts and a more affordable version that comes in vials for syringe use. Even with these options, some patients may face out-of-pocket costs totaling hundreds of dollars each month.
In November, the Biden administration proposed changes to Medicare's coverage policy regarding obesity drugs; however, beneficiaries can only receive coverage for weight-loss drugs when prescribed for other health conditions, such as reducing heart risks.
The FDA's decision was based on two clinical trials sponsored by the company, involving around 470 patients. One trial included those using continuous positive airway pressure (CPAP) machines, a standard treatment that helps maintain open airways. Results published in the New England Journal of Medicine indicated that treatment with Zepbound led to improvements in both groups of patients.
The primary goal of these studies was to assess improvements in the apnea-hypopnea index (AHI), which measures the frequency of breathing disruptions per hour during sleep. Participants' baseline AHI was approximately 50 events per hour, with an average body mass index (BMI) around 39, classifying them as obese.
In the trial involving patients not using CPAP, those treated with Zepbound experienced an average reduction of about 25 AHI events per hour after one year, compared to only five fewer events for the placebo group. Among those already using CPAP machines, the Zepbound group had about 29 fewer events per hour, while the placebo group saw a reduction of about six.
Additionally, patients taking Zepbound achieved significant weight loss, averaging 18% in the first trial and 20% in the second, compared to just 1.6% and 2.3% for those on placebo. This translates to an approximate weight loss of 45 to 50 pounds over a year, according to Lilly.
Furthermore, participants on the medication experienced reductions in blood pressure and inflammation, which are critical risk factors for cardiovascular complications linked to OSA and obesity. The most frequently reported side effects were gastrointestinal issues, typically mild to moderate, occurring mainly during the initial treatment phase or when increasing doses.
#sleepapneaawareness #zepbound #fdaapproval #healthnews #wellness #innovativetherapy
