CLINICAL QUESTION
Could tirzepatide be a potential treatment for patients with obstructive sleep apnea (OSA) and obesity?
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November 2024BOTTOM LINE
In two trials, participants with OSA and obesity who received tirzepatide had a clinically meaningful change in sleep-disordered breathing and alleviation of perceived sleep disturbance and sleep-related impairment, as well as reductions in common OSA-related cardiovascular risk factors.
BACKGROUND: Excess adiposity is a major reversible etiologic risk factor for OSA and its complications, and the benefit of substantial weight reduction in the treatment of people with OSA is well recognized. A pharmacologic intervention that targets obesity and its downstream effects may facilitate a holistic approach to treating the condition.
STUDY DESIGN: Prospective controlled study
SETTING: University of California, San Diego, La Jolla, Calif.
SYNOPSIS: In two phase 3 trials, researchers evaluated the safety and efficacy of tirzepatide for the treatment of adults with moderate-to-severe OSA (apnea-hypopnea index [AHI] >15 events per hour) and obesity (body mass index > 30). Trials were conducted at 60 sites across nine countries. Participants not receiving positive airway pressure (PAP) at baseline were enrolled in trial 1 (n = 234, 32.9% female; 46.6% > 50 years of age). Participants receiving PAP therapy at baseline were in trial 2 (n = 235, 27.7% female; 57.9% > 50 years of age). Participants were assigned to receive either the maximum tolerated dose of tirzepatide (10 or 15 mg) or a placebo for 52 weeks. The primary endpoint was AHI change from baseline; secondary endpoints included change in AHI, body weight, and sleep disturbance. Trial 1 changes in AHI between the tirzepatide and placebo groups at week 52 were –25.3 and –5.3 events per hour, respectively. In trial 2 the AHI change was –29.3 with tirzepatide and –5.5 with placebo. Findings showed significant improvements in the measurements for all prespecified key secondary endpoints with tirzepatide as compared with placebo. Study limitations include a lack of support for the assessment of cardiovascular outcomes.
CITATION: Malhotra A, Grunstein RR, Fietze I, et al. SURMOUNT-OSA Investigators. Tirzepatide for the treatment of obstructive sleep apnea and obesity [pubished online ahead of print June 21, 2024]. N Engl J Med.