Changes in patient-reported outcomes and objective assessments based on baseline symptom severity in SURMOUNT-OSA: Post-hoc analyses.

STUDY

OBJECTIVES

These post-hoc analyses of SURMOUNT-OSA evaluated patient-reported outcome measures (PROMs) and objective assessments, considering participants' baseline characterization of fatigue, sleepiness, snoring, and sleep quality.

METHODS

SURMOUNT-OSA included two 52-week randomized, placebo-controlled studies of tirzepatide (10/15mg) in participants with moderate-to-severe OSA and obesity (Study 1: participants not using positive airway pressure [PAP]; Study 2: participants using PAP). Participants were grouped by self-reported baseline severity of fatigue (Non-fatigued/Fatigued), sleepiness (Non-sleepy/Sleepy), snoring (Non-snoring/Snoring), and sleep quality (Good/Poor). Changes in PROMs and objective assessments from baseline to Week 52 were assessed per subgroup.

RESULTS

In both studies, tirzepatide treatment was consistently associated with greater improvements in PROMs and objective assessments than placebo. In Study 1, tirzepatide-treated participants in the Fatigued subgroup had numerically greater improvements vs Non-fatigued subgroup in FOSQ Activity Level (LSM difference from placebo: 0.33 vs 0.05), SF-36v2 Vitality, (8.5 vs 1.0), and SF-36v2 General Health scores (6.2 vs 1.4). The Sleepy subgroup showed numerically greater improvements versus Non-sleepy subgroup in PROMIS Short-Form Sleep-Related Impairment 8a scores (LSM difference: -7.1 vs -1.6) while the Poor sleep quality subgroup had numerically greater improvements versus Good sleep quality subgroup in PROMIS Short-Form Sleep Disturbance scores (LSM difference: -5.8 vs -1.2). Changes in PROMs were similar in both snoring subgroups. Study 2 patterns were generally consistent with Study 1. Tirzepatide treatment was associated with similar improvements in objective assessments (AHI, SASHB, weight, OSA remission) across all symptom severity subgroups in both studies.

CONCLUSIONS

Across subgroups, tirzepatide treatment was associated with greater improvements in PROMs than placebo. Participants with worse fatigue, sleepiness, and sleep quality at baseline generally had larger improvements on related PROMs than those with milder symptoms. Tirzepatide treatment was also associated with greater improvements in objective assessments versus placebo, though these changes were generally similar across baseline symptom severity subgroups.