Tirzepatide improved sleep and quality-of-life scores in SURMOUNT-OSA, analysis finds

In the phase 3 SURMOUNT-OSA trials, people with moderate-to-severe obstructive sleep apnea (OSA) and obesity who took tirzepatide reported better sleep, less daytime impairment and better quality of life than those who took a placebo, according to a new analysis of participant questionnaires ^[1].

SURMOUNT-OSA was two randomized, placebo-controlled trials. Participants received tirzepatide at 10 mg or 15 mg, or placebo, for 52 weeks ^[1]. Earlier results from the same program showed tirzepatide significantly reduced the apnea-hypopnea index (AHI), the count of times breathing slows or stops per hour of sleep, in this population ^[1].

The new paper reports on patient-reported outcome measures, or PROMs: standardized questionnaires that capture symptoms and daily functioning rather than machine-measured breathing. Comparing tirzepatide with placebo at Week 52, the researchers reported significant improvements on:

• PROMIS Short-Form Sleep-related Impairment 8a ^[1]
• PROMIS Short-Form v1.0 Sleep Disturbance 8b ^[1]
• Functional Outcomes of Sleep Questionnaire Activity-Level scores ^[1]
• EQ-5D-5L, a general health-related quality-of-life measure ^[1]
• Most domains of the Short-Form 36 Health Survey, Version 2 ^[1]

Tirzepatide was also associated with greater improvement than placebo on the Patient Global Impression of Status and Patient Global Impression of Change symptom scales ^[1]. In Study 1, the trial whose participants were not using positive airway pressure (PAP), participants reported significant changes on the Epworth Sleepiness Scale, a common measure of daytime sleepiness ^[1]. In Study 2, which enrolled PAP users, PAP was withdrawn before the sleep studies and questionnaires were given ^[1].

The paper's conclusion states that beyond objective improvements in AHI, the oxygen deficit associated with OSA, and cardiovascular risk factors, "people with OSA reported benefits in symptoms, functioning, and HRQoL following tirzepatide treatment" ^[1].

The results are reported as least-squares mean differences with 95% confidence intervals, shown in figures rather than in the abstract, and the abstract does not list the size of each change ^[1].

The paper carries a funding and conflict-of-interest statement: five authors list themselves as employees and stockholders of Eli Lilly and Company, which makes tirzepatide and holds the copyright on the publication, and two other authors report consulting, advisory board or speaking income from Lilly and other companies, including sleep-medicine device and drug makers ^[1]. The trial is registered as NCT05412004 ^[1].

Why it matters for patients

Sleep apnea is usually tracked with the AHI, a number generated by a sleep study. Patients often describe the condition differently — through daytime sleepiness, trouble concentrating and feeling worn out. This analysis suggests that for people with OSA and obesity, tirzepatide's effects showed up in those self-reported areas as well as in the breathing measure ^[1].

Because the comparison was against placebo over 52 weeks, the reported differences reflect the drug rather than simply taking part in a trial ^[1]. That said, trial averages do not predict what any one person will notice, and the abstract does not report how large the average changes were on each questionnaire ^[1].

The PAP detail matters for interpretation: in Study 2, treatment was withdrawn before assessments, so the questionnaire results describe participants' state without PAP during testing ^[1]. Whether those participants used PAP outside the assessment periods has not been reported.

Tirzepatide is also sold as Zepbound and Mounjaro. Nothing in these results changes the label or approval status of any product, and no dosing information is reported here.

What is not yet known

Whether the questionnaire improvements persist after tirzepatide is stopped has not been reported. The paper also does not address how these patient-reported changes relate to changes in cardiovascular risk factors over a longer period, or whether the results would apply to people with milder OSA or without obesity ^[1].