Abstract
Eli Lilly’s tirzepatide, known as Mounjaro for type 2 diabetes and Zepbound for obesity, has shown significant efficacy in treating obstructive sleep apnea (OSA) in the SURMOUNT-OSA trial. This groundbreaking study revealed that tirzepatide not only reduces the severity of OSA but also offers substantial cardiometabolic benefits, potentially transforming the treatment landscape for this common condition.
Key Points
- Tirzepatide Efficacy: Demonstrated up to a 62.8% reduction in OSA severity in the SURMOUNT-OSA trial.
- Dual Benefits: Significant weight loss and improvements in cardiovascular markers alongside OSA treatment.
- Disease Resolution: Nearly half of the participants achieved criteria for disease resolution.
- Broader Implications: Potential FDA approval could make tirzepatide the first pharmaceutical treatment for the underlying causes of OSA.
- GLP-1 Drug Expansion: Highlights the expanding therapeutic scope of GLP-1 drugs, following Wegovy’s label expansion to include cardiovascular risk reduction.
Introduction
Eli Lilly’s tirzepatide has demonstrated significant efficacy in treating obstructive sleep apnea (OSA), according to recent results from the SURMOUNT-OSA trial. Tirzepatide, already known for its effectiveness in managing type 2 diabetes (marketed as Mounjaro) and obesity (marketed as Zepbound), is now showing promise in addressing the complexities of OSA, a condition affecting millions globally.
The SURMOUNT-OSA Trial
The SURMOUNT-OSA trial was a phase 3 clinical study that aimed to evaluate the effectiveness of tirzepatide in adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Conducted across multiple countries, including the United States, Australia, and Germany, the trial enrolled 469 participants, who were divided into two groups: those using positive airway pressure (PAP) therapy and those not using PAP therapy.
Participants were administered either tirzepatide or a placebo over a 52-week period. The primary endpoint of the study was the change in the apnea-hypopnea index (AHI), a measure of sleep apnea severity. Key secondary endpoints included improvements in body weight, systolic blood pressure, inflammation markers (high-sensitivity C-reactive protein), and patient-reported outcomes on sleep-related impairment.
Key Findings from the Trial
The results of the SURMOUNT-OSA trial are remarkable:
- Reduction in Sleep Apnea Severity: Tirzepatide reduced the severity of OSA by up to 62.8%, which translates to approximately 30 fewer disruptive events per hour of sleep compared to the placebo group. This reduction was observed across both study groups, with and without PAP therapy.
- Significant Weight Loss: Participants treated with tirzepatide experienced substantial weight loss, with reductions of 18%-20% in body weight. This is particularly significant as obesity is a major risk factor for OSA.
- Cardiometabolic Improvements: Besides improving AHI, tirzepatide led to significant reductions in systolic blood pressure and inflammation markers, indicating its potential in mitigating cardiometabolic complications associated with OSA.
- Disease Resolution: In the trials, 43.0% and 51.5% of participants in the two studies achieved disease resolution, defined as an AHI of fewer than 5 events per hour or an AHI of 5-14 events per hour coupled with an Epworth Sleepiness Scale (ESS) score of ≤10. This suggests that nearly half of the patients could potentially see a complete resolution of their OSA symptoms.
Implications for Treatment
The findings from the SURMOUNT-OSA trial are poised to revolutionize the treatment landscape for OSA. Traditionally, continuous positive airway pressure (CPAP) therapy has been the primary treatment for OSA. However, many patients struggle with adherence to CPAP therapy due to discomfort and inconvenience. The introduction of tirzepatide as an alternative or complementary treatment offers a new avenue for those patients.
Dr. Atul Malhotra, the principal investigator of the study, emphasized the comprehensive benefits of tirzepatide, stating, “OSA can be very disruptive to daily life and affects a person’s long-term health when left untreated because it can lead to serious cardiometabolic complications. These data support the efficacy of tirzepatide in adults living with moderate-to-severe OSA and obesity and has the potential to add to our toolbox for OSA treatment.”
Expanding Horizons for GLP-1 Drugs
The success of tirzepatide in treating OSA is part of a broader trend in the medical community recognizing the multiple benefits of GLP-1 drugs. Recently, another GLP-1 drug, semaglutide (marketed as Wegovy for weight management), received FDA approval for a label expansion to include cardiovascular risk reduction. This approval highlights the growing evidence that GLP-1 drugs not only manage conditions like diabetes and obesity but also offer significant cardiovascular benefits.
As clinical trials continue to produce positive results, we can anticipate further label expansions for GLP-1 drugs, potentially revolutionizing treatment for a variety of conditions. The ability to address multiple health issues with a single medication could transform how we approach chronic disease management, making treatments more efficient and comprehensive.
Looking Forward
Eli Lilly has submitted tirzepatide for FDA approval for the treatment of moderate-to-severe OSA, with regulatory actions anticipated by the end of the year. If approved, tirzepatide would be the first pharmaceutical treatment for the underlying causes of sleep apnea, addressing both the obesity and OSA.
The dual-action benefits of tirzepatide underscore its potential to transform how we approach and manage complex conditions that intertwine metabolic and respiratory health. As more data emerges and further analyses are conducted, tirzepatide could become a cornerstone treatment, improving the quality of life for millions suffering from OSA.
Frequently Asked Questions
What is the cost of tirzepatide and is it covered by insurance?
The cost of tirzepatide can vary, and coverage by insurance may depend on the specific health plan and its formulary. Patients should check with their insurance provider to determine if tirzepatide is covered under their plan. Manufacturer discounts or patient assistance programs may also be available.
How long does it take to see results from tirzepatide for OSA?
Results from tirzepatide can typically be seen within a few weeks of starting treatment, with significant improvements in OSA severity and related health markers observed over the course of the 52-week SURMOUNT-OSA trial.
How does tirzepatide work to reduce OSA severity?
Tirzepatide is a GLP-1 and GIP receptor agonist that works by enhancing insulin secretion, reducing appetite, and promoting weight loss. The weight loss and metabolic improvements help reduce the severity of OSA by decreasing fat deposits around the upper airway, thus reducing airway obstruction during sleep.
What other conditions might tirzepatide be effective in treating?
Besides OSA, tirzepatide is effective in treating type 2 diabetes and obesity. Ongoing research is exploring its potential benefits for cardiovascular diseases, kidney diseases, and other metabolic conditions.
How does tirzepatide compare to other GLP-1 receptor agonists like semaglutide (Wegovy)?
Tirzepatide is a dual GLP-1 and GIP receptor agonist, whereas semaglutide is only a GLP-1 receptor agonist. Both drugs are effective for weight loss and blood sugar control, but tirzepatide may offer additional benefits due to its dual action. Comparative studies are ongoing.
