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27-06-2024 | Obstructive Sleep Apnea Syndrome | Editor's Choice | News

Tirzepatide shows promise as a pharmacologic treatment for obstructive sleep apnea

Author: Laura Cowen

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medwireNews: Adults with moderate-to-severe obstructive sleep apnea and obesity derive significant benefits from treatment with tirzepatide, regardless of whether they are receiving positive airway pressure (PAP) therapy, show data from the SURMOUNT-OSA phase 3 trials.

The long-acting, glucose-dependent insulinotropic polypeptide receptor and glucagon-like peptide-1 receptor agonist has previously been shown to significantly reduce excess body weight, improve blood pressure, and reduce markers of inflammation and vascular endothelial dysfunction.

In the current study, Atul Malhotra (University of California, San Diego, USA) and colleagues tested its efficacy as a potential pharmacologic treatment for obstructive sleep apnea – to date, treatment has typically focused on mechanical support during sleep.

They recruited 469 individuals with moderate-to-severe obstructive sleep apnea and obesity and divided them into two subtrials involving participants who were not receiving PAP therapy at baseline (trial 1, n=234) and those who had been receiving PAP therapy for at least 3 months (trial 2, n=235).

The participants in each subtrial were randomly assigned to receive tirzepatide at the maximum tolerated dose of 10 mg or 15 mg once weekly, or placebo for 52 weeks. All the participants also received regular lifestyle counseling sessions regarding the maintenance of healthy nutrition while adhering to a 500 kcal/day deficit and at least 150 minutes/week of physical activity.

At baseline, the mean apnea–hypopnea index (AHI), defined as the number of apneas and hypopneas during an hour of sleep, was 51.5 in trial 1 and 49.5 in trial 2, while the mean BMI was 39.1 kg/m2 and 38.7 kg/m2, respectively.

The researchers report that, at 52 weeks, the AHI in patients not receiving PAP therapy at baseline had fallen by a mean of 25.3 events per hour with tirzepatide and by 5.3 events per hour with placebo, corresponding to a significant estimated treatment difference of 20.0 events per hour.

For those who were receiving PAP therapy at baseline, the mean reductions in the AHI with tirzepatide and placebo were 29.3 and 5.5 events per hour, respectively, giving a significant estimated treatment difference of 23.8 events per hour.

Writing in The New England Journal of Medicine, Malhotra et al say that the reduction they observed with tirzepatide is “considered clinically relevant; the American Academy of Sleep Medicine defines the clinical significance threshold for the AHI as 15 or more events per hour.”

They also report that “[a] meaningful percentage of participants who received tirzepatide (up to 50.2%) in both SURMOUNT-OSA trials met the combined key secondary end-point criteria of fewer than 5 AHI events per hour or 5 to 14 AHI events per hour and an [Epworth Sleepiness Scale score] of 10 or less, which is relevant because these thresholds for disease severity represent a level at which PAP therapy may not be recommended.”

Furthermore, treatment with tirzepatide was associated with significantly greater improvements than placebo for all key secondary endpoints, including the percent change in AHI and bodyweight and changes in hypoxic burden, patient-reported sleep impairment and disturbance, high-sensitivity C-reactive protein concentration, and systolic blood pressure.

The researchers note that, as expected, the most common adverse events (AEs) with tirzepatide were mild-to-moderate diarrhea, nausea, vomiting, and constipation that occurred most frequently during the dose-escalation phase. Serious AEs were reported by 7.5% of the participants overall and occurred at a similar rate across the two tirzepatide and two placebo groups.

Malhotra and team say: “Patients with obstructive sleep apnea are sometimes unable or unwilling to adhere to PAP treatment, and PAP has not been shown to affect cardiovascular complications and death in obstructive sleep apnea; therefore, there is a need for additional treatment options.”

According to editorialist Sanjay Patel, from the University of Pittsburgh in Pennsylvania, USA, tirzepatide could meet this need. He writes: “The initial results from the SURMOUNT-OSA trial show the usefulness of tirzepatide as an adjunctive treatment to address coexisting obesity in patients with obstructive sleep apnea.”

However, he adds: “Additional analyses of the effects of tirzepatide on a broader range of patient-reported outcome measures by the SURMOUNT-OSA team will be eagerly awaited to evaluate the potential utility of tirzepatide as a sole treatment for obstructive sleep apnea.

If the results of those analyses are promising, the news of an addition of a pharmacologic option to the clinical armamentarium for obstructive sleep apnea will be welcomed by many patients and clinicians alike.”

The study was simultaneously presented at the ADA 84th Scientific Sessions in Orlando, Florida, USA.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2024 Springer Healthcare Ltd, part of the Springer Nature Group

New Engl J Med 2024; doi:10.1056/NEJMoa2404881
New Engl J Med 2024; doi:10.1056/NEJMoa2407117

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