(By Dr. Joseph D. Lim and Dr. Kenneth Lester Lim, BS-MMG, DDM, MSc-OI)
A TREATMENT for moderate to severe obstructive sleep apnea (OSA) in adults with obesity has been approved by the U.S. Food and Drug Administration.
Zepbound (tirzepatide) is to be used in combination with a reduced-calorie diet and increased physical activity.
The US FDA granted the approval to Eli Lilly and Co. on December 20, 2024
It is the first drug treatment option for certain patients with obstructive sleep apnea, said Sally Seymour, M.D., Director of the Division of Pulmonology, Allergy, and Critical Care in the Center for Drug Evaluation and Research, US FDA. “This is a major step forward for patients with obstructive sleep apnea.”
OSA occurs when a person’s upper airway becomes blocked, causing pauses in breathing during sleep. While OSA can affect anyone, it is more common in people who are overweight or obese.
Sleep apnea concerns dentists because it causes oral health issues such as tooth decay, dry mouth, teeth grinding, temporomandibular joint disorder and jaw pain.
Zepbound works by activating receptors of hormones secreted from the intestine to reduce appetite and food intake, according to the US FDA. By reducing body weight, studies show that Zepbound also improves OSA, it says.
Zepbound’s approval for moderate to severe OSA in adults with obesity is based on two randomized, double-blind, placebo-controlled studies of 469 adults without type 2 diabetes.
One study enrolled participants using positive airway pressure (PAP), the standard of care for moderate to severe OSA, and one study enrolled participants unable or unwilling to use PAP. In both studies, participants randomly received either 10 or 15 milligrams of Zepbound or placebo once weekly for 52 weeks.
After 52 weeks of treatment in both studies, participants who received Zepbound experienced a statistically significant and clinically meaningful reduction in events of apnea. Participants treated with Zepbound had a significant decrease in body weight compared with placebo at 52 weeks. The improvement in AHI in participants with OSA is likely related to body weight reduction with Zepbound, according to the US FDA.
It said Zepbound can cause side effects such as nausea, diarrhea, vomiting, constipation, abdominal (stomach) discomfort and pain, injection site reactions, fatigue, hypersensitivity (allergic) reactions (typically fever and rash), burping, hair loss and gastroesophageal reflux disease.
Zepbound causes thyroid C-cell tumors in rats. It is unknown whether Zepbound causes such tumors, including medullary thyroid cancer, in humans. Zepbound should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2, the US FDA said.
Zepbound should not be used in patients with a history of severe allergic reaction to tirzepatide (its active ingredient) or to any of its other ingredients. Patients should stop Zepbound immediately and seek medical help if a severe allergic reaction is suspected.
Dr. Joseph D. Lim, Ed. D., is the former Associate Dean of the College of Dentistry, University of the East; former Dean, College of Dentistry, National University; Past President and Honorary Fellow of the Asian Oral Implant Academy; Honorary Fellow of the Japan College of Oral Implantologists; Honorary Life Member of the Thai Association of Dental Implantology; and Founding Chairman of the Philippine College of Oral Implantologists. For questions on dental health, e-mail jdlim2008@gmail.com or text 0917-8591515.
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Dr. Kenneth Lester Lim, BS-MMG, DDM, MSc-OI, graduated Doctor of Dental Medicine, University of the Philippines, College of Dentistry, Manila, 2011; Bachelor of Science in Marketing Management, De la Salle University, Manila, 2002; and Master of Science (MSc.) in Oral Implantology, Goethe University, Frankfurt, Germany, 2019. He is an Associate Professor; Fellow, International Congress of Oral Implantologists; and Fellow, Philippine College of Oral Implantologists. For questions on dental health, e-mail limdentalcenter@gmail.com./PN
