Recent research published in The New England Journal of Medicine reveals that an experimental drug aimed at obesity shows promise in alleviating symptoms of obstructive sleep apnea (OSA), such as breathing interruptions, in two clinical trials.
Obstructive sleep apnea is a significant issue, affecting over 50 million people in the U.S., with about 80% of cases remaining undiagnosed, as reported by the National Sleep Foundation.
The study focused on retatrutide, a weight-loss drug being developed by Eli Lilly, assessing its potential effectiveness for those struggling with OSA and who are either overweight or obese.
Currently, retatrutide is under investigation in phase 3 TRIUMPH trials as a possible treatment for obesity and related metabolic disorders, but it has yet to receive FDA approval.
Furthermore, the FDA has issued warnings regarding unauthorized versions of retatrutide that are being sold illegally online for weight loss purposes.
Study Details
The trials involved two randomized phase 3 studies with 691 adults experiencing moderate to severe sleep apnea, all having a BMI of 27 or higher. Participants were administered weekly injections of retatrutide at doses of 4, 9, or 12 milligrams, or a placebo, and they were monitored for 80 weeks.
Among the participants, 243 did not have type 2 diabetes, while 448 did. Those receiving retatrutide experienced weight loss ranging from 12% to nearly 20% and showed a significant decrease in breathing interruptions compared to those on a placebo.
Notably, around 68% of participants noted more than a 50% improvement in their OSA symptoms, irrespective of diabetes status.
The research also indicated that the severity and duration of low-oxygen episodes tied to breathing disruptions, known as hypoxic burden, decreased by approximately 75% in participants without diabetes and 65% for those with it.
The team concluded that retatrutide resulted in considerably greater reductions in the apnea-hypopnea index (AHI) when compared to the placebo among adults with OSA who were either overweight or obese, regardless of their diabetes status.
However, the lack of FDA approval for retatrutide was noted as a limitation, and further investigations are necessary to explore its long-term effects, particularly on cardiovascular health.
Expert Reaction
Dr. Virend Somers, a cardiologist and co-author from Mayo Clinic, expressed that while the outcomes were anticipated, he was somewhat taken aback by the significant benefits observed in patients with type 2 diabetes and the marked decrease in sleep apnea symptoms.
He pointed out that OSA often goes undiagnosed and inadequately treated. “This is a very exciting time in treating sleep apnea patients,” Somers remarked.
Given the association of sleep apnea with increased risks for heart attacks, strokes, high blood pressure, and atrial fibrillation, the trial outcomes are particularly relevant. Participants saw reductions in multiple cardiovascular risk factors, including systolic blood pressure, LDL cholesterol levels, systemic inflammation, and neck circumference.
Somers emphasized that a reduction in these factors could hint at lower cardiovascular risk. “In diabetics, blood pressure is pivotal in determining future cardiovascular risk, so the significant reductions we observed are both surprising and encouraging,” he noted.
Moreover, retatrutide also had a positive impact on various diabetes-related indicators. In those without diabetes, insulin levels dropped more than 50%, while in the group with type 2 diabetes, 40% transitioned from diabetes to prediabetes, and another 40% no longer qualified as diabetic.
These enhancements seem largely attributed to weight loss, which can foster improved sleep quality and reduce sleep-related problems, according to Somers.
