The primary medicine for obstructive sleep apnea has been authorized by the US Meals and Drug Administration (FDA).
On Dec. 20, the FDA introduced that the company has authorized Eli Lilly’s Zepbound (tirzepatide) to deal with average to extreme obstructive sleep apnea (OSA) in adults with weight problems.
The drug is to be paired with a reduced-calorie weight-reduction plan and elevated bodily exercise, the FDA famous.
Sally Seymour, M.D., director of the Division of Pulmonology, Allergy and Vital Care within the FDA’s Middle for Drug Analysis and Analysis in Washington, DC, applauded the approval in an announcement.
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” Seymour wrote.
“This is a major step forward for patients with obstructive sleep apnea.”
OSA happens when the higher airway turns into blocked and causes pauses in respiration throughout sleep, in accordance with the FDA.
The situation is extra widespread in people who find themselves obese or overweight.
Much like semaglutide therapies like Ozempic and Wegovy, Zepbound prompts receptors of hormones secreted from the gut (GLP-1 and GIP) to scale back urge for food and meals consumption.
Research present that by lowering physique weight, Zepbound “also improves OSA,” the FDA famous.
In a 52-week research, members handled with Zepbound skilled “statistically significant and clinically meaningful reduction in events of apnea or hypopnea,” and a big share of members achieved remission or “resolution of symptoms.”
Zepbound-treated sufferers additionally reported a big lower in physique weight, the FDA talked about.
The drug can reportedly trigger unwanted side effects like nausea, diarrhea, vomiting, constipation, abdomen discomfort and ache, injection web site reactions, fatigue, allergic reactions (sometimes fever and rash), burping, hair loss and gastroesophageal reflux illness.
Whereas Zepbound causes thyroid C-cell tumors in rats, it’s unknown whether or not it causes these tumors in people, so it shouldn’t be utilized by sufferers with a private or household historical past of medullary thyroid most cancers or with a number of endocrine neoplasia syndrome kind 2, per the FDA.
The company encourages all OSA sufferers to seek the advice of with a health care provider earlier than taking Zepbound and to observe for any issues.
Sleep knowledgeable Dr. Wendy Troxel, who’s a RAND Company senior behavioral specialist and licensed medical psychologist in Utah, known as the FDA’s approval a “promising advancement for the millions of people who suffer from this condition.”
About 30 million individuals endure from sleep apnea within the US, Troxel instructed Fox Information Digital.
Whereas the most typical remedy for sleep apnea — constructive airway stress (PAP) — is “highly effective” at treating the situation, as much as 50% of sufferers are “non-adherent,” she mentioned.
“Zepbound promotes weight loss and has been shown to reduce apnea events,” Troxel famous.
“For obese individuals with moderate to severe sleep apnea, this new treatment option may offer an important alternative or adjunctive treatment, particularly for those who struggle with sleep apnea therapies, such as positive airway pressure.”
Troxel added that treating sleep apnea is “critical not only for the patient’s health and well-being, but also for their bed partners, who are often the ‘hidden casualties’ of untreated sleep apnea, given that loud snoring and gasping for air are primary symptoms,” she mentioned.
Dr. William Lu, medical director of Dreem Well being in San Francisco, instructed Fox Information Digital that weight problems and sleep apnea are “two of the most prevalent health conditions that affect Americans today.”
“And they go hand in hand,” he mentioned.
“For the patients who qualify and have no contraindications, tirzepatide has the opportunity to be a generational medication that can help people lose weight, reduce the severity of sleep apnea and improve overall health.”
“We still need to emphasize shifting the diet and health habits of many, but this is a fantastic start.”
Getting examined for sleep apnea is “critical for your health,” Lu mentioned, and may be a requirement for getting protection for the medicine.
Fox Information Digital reached out to Eli Lilly requesting remark.
