On December 20, 2024, the U.S. Food and Drug Administration (FDA) has approved Eli Lilly's Zepbound (tirzepatide) as the first medication for treating moderate to severe obstructive sleep apnea (OSA) in adults (older than 18 years) with obesity.
OSA is a condition characterized by repeated interruptions in breathing during sleep due to airway obstruction, leading to fragmented sleep and reduced oxygen levels. Traditionally, treatments have included lifestyle changes, continuous positive airway pressure (CPAP) devices, and surgical interventions. The approval of Zepbound introduces a pharmacological option for patients who may not tolerate or benefit from existing therapies.
Zepbound is a once-weekly injectable medication that mimics the activity of 2 hormone receptors, GLP-1 and GIP, which help regulate blood sugar levels and appetite. Originally developed for type 2 diabetes, it has demonstrated significant weight loss benefits, making it effective for conditions like obesity and now OSA.
This also suggests that other GLP-1 weight-loss medications like ozempic, wegovy, mounjaro, trulicity, etc would also help with obstructive sleep apnea. After all, it is the weight-loss itself that helps with sleep apnea, whether through diet and exercise or now medications.
The FDA's decision was based on the SURMOUNT-OSA research trial, a multi-center, randomized, double-blind study involving adults with moderate to severe OSA and obesity. Participants treated with Zepbound experienced a substantial reduction in the Apnea-Hypopnea Index (AHI), a measure of the severity of sleep apnea. Key secondary endpoints, including weight loss and improvements in sleep-related quality of life, were also achieved.
The approval of Zepbound is expected to impact the market for OSA treatments, particularly devices like CPAP machines. However, some experts believe that combining pharmacological treatments with existing therapies may offer the most benefit to patients.
Patients and healthcare providers should engage in thorough discussions to determine the most appropriate treatment plan, considering the potential benefits and risks associated with Zepbound. As with any medication, adherence to prescribed guidelines and monitoring for side effects are crucial to ensure optimal outcomes.
Such potential side effects (common to all GLP-1 medications) include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn.
To minimize the side effects and allow time for the body to get used to this medication, there is a recommended dose escalation schedule as follows:
• The recommended starting dosage is 2.5 mg injected subcutaneously (to thigh, arm, or abdomen) once weekly for 4 weeks. Increase the dosage in 2.5 mg increments after at least 4 weeks until recommended maintenance dosage is achieved. Consider treatment response and tolerability when selecting the maintenance dosage.
• The recommended maintenance and maximum dosage for obstructive sleep apnea is 10 mg or 15 mg injected subcutaneously once weekly.
Contraindications include if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). In the animal model, GLP-1 medications have caused these types of cancers.
Do keep in mind that because this is such a new medical indication, most insurances will NOT pay for this medication. At a minimum, they will require the following to just be considered eligible (and even then, they may still deny):
• previously tried other weight loss treatments
• having successfully lost at least 5% of your weight over a certain period of time
• taking into account weight-related conditions
• tried CPAP machine, mandibular advancement devices
• have type 2 diabetes
Please contact your endocrinologist or primary care doctor to see if Zepbound is right for you!
No comments:
CLICK to Post a Comment