Eli Lilly plans to submit the study results to the FDA
Weight loss drugs like Ozempic and Mounjaro have gained great traction in recent months, and now drugmakers have found another benefit of the popular medications.
Eli Lilly, the manufacturer of the weight loss drug Zepbound (tirzepatide), learned that in addition to weight loss, the drug was also effective at improving patients sleep apnea symptoms.
Obstructive sleep apnea (OSA) impacts 80 million adults in the U.S, with more than 20 million living with moderate-to-severe OSA, said Dr. Jeff Emmick, senior vice president, Product Development at Eli Lilly. However, 85% of OSA cases go undiagnosed and therefore untreated.
Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease.
Weight loss and sleep apnea
Researchers conducted two rounds of the clinical trial to determine how Zepbound affected both sleep apnea and obesity. In both trials, participants took either 10 mg or 15 mg of Zepbound.
Apnea-hypopnea index (AHI) was the primary outcome measured in terms of sleep apnea. This figure measures the intensity of a persons sleep apnea depending on how often their breathing is obstructed in their sleep.
The first round of the study lasted one year and none of the participants were using any kind of positive airway therapy (PAP) for their sleep apnea. At the end of the year, the study showed that Zepbound yielded stronger outcomes for weight loss and sleep apnea than the placebo.
Patients taking the drug went from nearly 28 breathing events per hour at the start of the study to fewerthan five after taking the drug. On top of that, body weight decreased from 18.1% at the start of the study to 1.3%.
The second round of the study was similar, except patients were using PAP for sleep apnea throughout the entirety of the study. However, Zepbound still proved to be effective at reducing sleep apnea-related symptoms.
AHI went from 30.4 events per hour when the study began to six events per hour after one year. Similarly, these patients experienced a reduction in body weight reduction from 20.1% at baseline to 2.3% at the end of the study.
Between the two studies, the drug was found to reduce AHI by nearly 65%.
Eli Lilly is now taking these results to the FDA in an effort to get the drug approved for both obesity and obstructive sleep apnea.
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Posted: 2024-04-18 12:59:47