Eli Lilly announced detailed results from the SURMOUNT-OSA phase 3 clinical trials evaluating tirzepatide injection for the treatment of moderate-to-severe obstructive sleep apnea, or OSA, in adults with obesity, with and without positive airway pressure, or 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, 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 and presented at the American Diabetes Association 84th Scientific Sessions. In a key secondary endpoint, the efficacy estimand showed that 43.0% and 51.5% 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 score of less than or equal to 10. “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 and ESS measures, at which point PAP therapy may not be recommended.”
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