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An experimental obesity drug significantly reduced breathing interruptions and other symptoms of obstructive sleep disorder in two clinical trials, according to new research published in The New England Journal of Medicine.
Obstructive sleep apnea (OSA) affects more than 50 million Americans, and about 80% of cases are undiagnosed, according to the National Sleep Foundation.
The study examined whether retatrutide, an investigational weight-loss drug from Eli Lilly, could help treat OSA in adults who were overweight or obese.
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Retatrutide is being evaluated in phase 3 TRIUMPH trials as a potential treatment for obesity and related metabolic conditions. The drug has not been approved by the FDA.
The FDA has warned that unauthorized versions of retatrutide have been illegally marketed and sold online for weight loss.
The researchers measured changes in the apnea-hypopnea index (AHI), which counts breathing interruptions per hour of sleep. (iStock)
Study details
The two phase 3 randomized trials included 691 adults with moderate-to-severe sleep apnea and a BMI of at least 27. Participants received once-weekly injections of retatrutide at doses of 4, 9 or 12 milligrams, or a placebo, and were followed for 80 weeks.
The trials included 243 participants without type 2 diabetes and 448 with the condition.
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Participants who received retatrutide lost between 12% and nearly 20% of their body weight and experienced significantly fewer breathing interruptions than those who received a placebo.
About 68% of participants experienced more than a 50% improvement in OSA symptoms, regardless of whether they had type 2 diabetes.
Retatrutide improved more than 50% of OSA symptoms in 68% of participants over the 80-week period. (iStock)
The study also found that hypoxic burden — the severity and duration of low-oxygen episodes caused by breathing disruptions during sleep — fell by about 75% among participants without type 2 diabetes and 65% among those with the condition.
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The researchers concluded that retatrutide led to significantly greater reductions in AHI (breathing interruptions) than a placebo among adults with OSA who were obese or overweight, regardless of whether they had type 2 diabetes.
The need for CPAP machines could be reduced by drug therapy, the researchers considered. (iStock)
The researchers noted that retatrutide’s lack of FDA approval was a limitation, and further studies are needed to determine how the drug may affect long-term cardiovascular outcomes.
Expert reaction
Study co-author Dr. Virend Somers, a cardiologist and professor of medicine at Mayo Clinic in Rochester, Minnesota, told Fox News Digital that while the results were expected, he was surprised by the “magnitude of benefit in patients with type 2 diabetes,” as well as the significant reduction in sleep apnea.
“OSA is often under-diagnosed and under-treated.”
“This is a very exciting time in treating sleep apnea patients,” Somers said.
Sleep apnea is associated with a higher risk of heart attacks, strokes, high blood pressure and atrial fibrillation. In the trial, participants experienced reductions in several cardiovascular risk factors, including systolic blood pressure, LDL cholesterol, systemic inflammation and neck circumference.
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“A reduction in these measures would predict whether these patients were at increased cardiovascular risk,” Somers told Fox News Digital.
“In diabetics, blood pressure is a key determinant of future cardiovascular risk, and the fact that we were able to reduce it so significantly was both surprising and exciting.”
Sleep apnea patients are at higher risk for heart attacks, strokes, high blood pressure and atrial fibrillation. (iStock)
Somers said retatrutide also improved several diabetes-related measures.
In participants without diabetes, insulin levels fell by more than 50%. Among those with type 2 diabetes, 40% progressed from diabetes to prediabetes and another 40% no longer met the criteria for diabetes, according to the researcher.
The improvements were largely linked to weight loss, which can lead to better sleep and reduced sleep-related impairment, he said.
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“[The participants] reported much improved sleep beyond just the sleep apnea — what we call sleep-related impairment was significantly reduced,” Somers said.
The study included participants who were using CPAP and those who were not. Somers said CPAP use generally declined during the study, suggesting that some patients may eventually require less device-based treatment.
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Dr. Wendy Troxel, a RAND senior behavioral scientist in Utah who was not involved in the study, noted that OSA is often under-diagnosed and under-treated, especially among postmenopausal women.
“Although CPAP remains the frontline treatment for sleep apnea, my hope is that greater awareness of treatment options may encourage more people to get screened and seek treatment,” she told Fox News Digital.
Somers noted that the condition completely resolved in about 25% of participants without diabetes and 15% of those with type 2 diabetes.
“This is a very exciting time in treating sleep apnea patients.”
The study’s findings do not mean patients should stop using CPAP or other prescribed treatments, the researchers emphasized. Additional research is needed to determine retatrutide’s long-term safety and effectiveness for sleep apnea.
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“There’s hope on the horizon,” Somers said. “We have the CPAP, we have mandibular devices, we have postural therapy, where you try to avoid sleeping on your back, and now we’ve got drug therapies that can potentially not just reduce your apnea, but also make you sleep better … and reduce the risk of future cardiovascular events.”