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Tirzepatide reduced obstructive sleep apnea (OSA) severity, with up to 51.5% of participants meeting the criteria for disease resolution.- Eli Lilly

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Published:23rd Jun 2024

Eli Lilly and Company announced detailed results from the SURMOUNT-OSA phase III clinical trials evaluating tirzepatide injection (10 mg or 15 mg) for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity, with and without positive airway pressure (PAP) therapy.

In both studies, tirzepatide achieved all primary and key secondary endpoints for both the efficacy and treatment-regimen estimands and demonstrated a mean reduction of up to 62.8% on the apnea-hypopnea index (AHI), or about 30 fewer events restricting or blocking a person's airflow per hour of sleep, compared to placebo. Full results were published in The New England Journal of Medicine (NEJM) and presented at the American Diabetes Association® (ADA) 84th Scientific Sessions.

In a key secondary endpoint , the efficacy estimand showed that 43.0% (Study 1) and 51.5% (Study 2) of participants treated with tirzepatide at the highest dose met the criteria for disease resolution. In this context, "disease resolution" means achieving an AHI of fewer than 5 events per hour, or an AHI of 5-14 events per hour and an Epworth Sleepiness Scale (ESS) score of less than 10. ESS is a standard questionnaire designed to assess excessive daytime sleepiness.

OSA is a complex disease that can impact the progression of serious cardiometabolic complications, including hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation and type 2 diabetes. Participants treated with tirzepatide in both studies experienced significant improvements in all key secondary endpoints including systolic blood pressure, hypoxic burden and high-sensitivity C-reactive protein (hsCRP), an inflammation marker, compared to placebo.

"In the trials, patients with moderate-to-severe obstructive sleep apnea and obesity treated with tirzepatide experienced about 30 fewer disruptive events every hour of sleep and nearly half achieved disease resolution," said Atul Malhotra, MD, Peter C. Farrell presidential chair, professor of medicine at University of California San Diego School of Medicine and director of sleep medicine at UC San Diego Health. "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."

"There are currently no pharmaceutical treatment options to address the underlying cause of OSA, a complex disease that disrupts the daily lives of 80 million people in the U.S. alone and is linked to serious health complications," said Jeff Emmick, MD, Ph.D., senior vice president, product development, Lilly. "The SURMOUNT-OSA results showed a significant proportion of patients with moderate-to-severe OSA and obesity treated with tirzepatide achieved disease resolution based on predetermined AHI(Apnea-Hypopnea index) and ESS (Epworth sleepiness Scale) measures, at which point PAP (positive airway pressure (PAP)) therapy may not be recommended."

The overall safety profile of tirzepatide in SURMOUNT-OSA studies was similar to previously reported SURMOUNT and SURPASS trials. The most commonly reported adverse events in SURMOUNT-OSA were gastrointestinal related and generally mild to moderate in severity. The most frequent events reported by those on tirzepatide compared with placebo, respectively, were diarrhea (26.3% vs 12.5%), nausea (25.4% vs 10.0%) and vomiting (17.5% vs 4.2%) in SURMOUNT-OSA Study 1, and diarrhea (21.8% vs 8.8%), nausea (21.8% vs 5.3%) and constipation (15.1% vs 4.4%) in SURMOUNT-OSA Study 2. Adverse events led to discontinuation of study treatment in 9 participants taking tirzepatide (5 in Study 1 and 4 in Study 2) and 10 taking placebo (2 in Study 1 and 8 in Study 2).

See- "Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity" :Authors: Atul Malhotra, M.D., Ronald R. Grunstein, M.D., Ph.D., Ingo Fietze, M.D., Terri E. Weaver, Ph.D., Susan Redline, M.D., M.P.H., Ali Azarbarzin, Ph.D., Scott A. Sands, Ph.D., +5, for the SURMOUNT-OSA Investigators. Published June 21, 2024. DOI: 10.1056/NEJMoa2404881.

Condition: Sleep Apnea + Obesity
Type: drug

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