HQ Team
June 22, 2024: Tirzepatide, the main ingredient in an obesity drug of Eli Lilly and Company, has helped resolve moderate-to-severe obstructive sleep apnea in 52.% of adult patients in two separate trials, according to a company statement.
The end-stage trials evaluated tirzepatide injection treatment of sleep apnea in obese adults, with and without positive airway pressure therapy.
Tirzepatide is an approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) treatment for chronic weight management, commercialised by Lilly as Zepbound in the US and Mounjaro in global markets outside the US.
“In a key secondary endpoint, the efficacy estimand showed that 43.0% of patients in the first study and 51.5% in the second treated with tirzepatide at the highest dose met the criteria for disease resolution, according to the statement.
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.”
An estimand is a systematic description of the treatment effect to be quantified to answer the trial’s research objective. The estimand consists of five attributes: Treatment, Population, Variable, Population-Level Summary, and Handling of Intercurrent Events.
Excessive daytime sleepiness
“Disease resolution” in this context, 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. The scale is a standard questionnaire designed to assess excessive daytime sleepiness.
The trials were conducted on 469 participants across the US, Australia, Brazil, China, Germany, Japan, Czechia, Mexico and Taiwan in a 1:1 ratio to receive tirzepatide maximum tolerated dose (MTD) 10 mg or 15 mg or the placebo.
Obstructive Sleep Apnea 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.
Systolic blood pressure
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, an inflammation marker, compared to placebo.
Lilly has submitted tirzepatide for the treatment of moderate-to-severe obstructive sleep apnea and obesity to the US Food and Drug Administration and will initiate submissions for other global regulatory agencies in the coming weeks.
“These data support the efficacy of tirzepatide in adults living with moderate-to-severe obstructive sleep apnea and obesity and has the potential to add to our toolbox for obstructive sleep apnea treatment,” said Atul Malhotra, MD, Peter C. Farrell presidential chair, professor of medicine at the University of California San Diego School of Medicine and director of sleep medicine at UC San Diego Health.
Jeff Emmick, MD, Ph.D., senior vice president, product development, at Lilly, said: ”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.”
Data from the trials were presented at the American Diabetes Association’s scientific meeting in Orlando, Florida.
