BACKGROUND: Qualitative interviews can supplement clinical trial results by providing in-depth insights into participant experiences. In the recent SURMOUNT-OSA (NCT05412004) phase III trials, tirzepatide demonstrated favorable efficacy and safety in patients with moderate-to-severe obstructive sleep apnea and obesity. To explore participants' obstructive sleep apnea and treatment-related experiences, qualitative exit interviews were held with a subset of trial participants.
METHODS: One-on-one qualitative telephone interviews were conducted as participants exited the trial. Participants described their obstructive sleep apnea symptoms, impacts, and sleep quality before and after participation in the trial. They further reported on the meaningfulness of treatment-related changes, experiences, and satisfaction. Interview transcripts were analyzed using ATLAS.ti.
RESULTS: Seventy US-based and 12 Germany-based participants (tirzepatide n = 49, placebo n = 33) had a mean age of 52.7 years. Most were male (61.0%), non-Hispanic (87.8%), and White (91.5%). The "worst" obstructive sleep apnea symptoms experienced overall included snoring and temporary breath cessation, and the "worst" impacts were sleep-related impairment and sleep disturbance. Greater proportions of tirzepatide-treated than placebo-treated patients reported improvements in key symptoms and impacts of obstructive sleep apnea and considered them to be meaningful. Tirzepatide-treated participants also reported improved sleep quality and daytime functioning. Treatment satisfaction was higher among tirzepatide-treated participants than placebo-treated participants. The most common treatment-related likes were ease of treatment administration, weight reduction, and obstructive sleep apnea symptom improvement.
CONCLUSIONS: These findings highlight the range of symptoms and impacts experienced by individuals with obstructive sleep apnea and obesity, and support a positive effect of treatment with tirzepatide.
