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Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity.
Malhotra, Atul; Grunstein, Ronald R; Fietze, Ingo; Weaver, Terri E; Redline, Susan; Azarbarzin, Ali; Sands, Scott A; Schwab, Richard J; Dunn, Julia P; Chakladar, Sujatro; Bunck, Mathijs C; Bednarik, Josef.
Affiliation
  • Malhotra A; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
  • Grunstein RR; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
  • Fietze I; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
  • Weaver TE; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
  • Redline S; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
  • Azarbarzin A; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
  • Sands SA; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
  • Schwab RJ; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
  • Dunn JP; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
  • Chakladar S; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
  • Bunck MC; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
  • Bednarik J; From the University of California, San Diego, La Jolla (A.M.); Woolcock Institute of Medical Research, Macquarie University, Royal Prince Alfred Hospital, and the University of Sydney - all in Sydney (R.R.G.); the Center of Sleep Medicine, Charité University Hospital Berlin, Berlin (I.F.); the Colle
N Engl J Med ; 2024 Jun 21.
Article in En | MEDLINE | ID: mdl-38912654
ABSTRACT

BACKGROUND:

Obstructive sleep apnea is characterized by disordered breathing during sleep and is associated with major cardiovascular complications; excess adiposity is an etiologic risk factor. Tirzepatide may be a potential treatment.

METHODS:

We conducted two phase 3, double-blind, randomized, controlled trials involving adults with moderate-to-severe obstructive sleep apnea and obesity. Participants who were not receiving treatment with positive airway pressure (PAP) at baseline were enrolled in trial 1, and those who were receiving PAP therapy at baseline were enrolled in trial 2. The participants were assigned in a 11 ratio to receive either the maximum tolerated dose of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks. The primary end point was the change in the apnea-hypopnea index (AHI, the number of apneas and hypopneas during an hour of sleep) from baseline. Key multiplicity-controlled secondary end points included the percent change in AHI and body weight and changes in hypoxic burden, patient-reported sleep impairment and disturbance, high-sensitivity C-reactive protein (hsCRP) concentration, and systolic blood pressure.

RESULTS:

At baseline, the mean AHI was 51.5 events per hour in trial 1 and 49.5 events per hour in trial 2, and the mean body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) was 39.1 and 38.7, respectively. In trial 1, the mean change in AHI at week 52 was -25.3 events per hour (95% confidence interval [CI], -29.3 to -21.2) with tirzepatide and -5.3 events per hour (95% CI, -9.4 to -1.1) with placebo, for an estimated treatment difference of -20.0 events per hour (95% CI, -25.8 to -14.2) (P<0.001). In trial 2, the mean change in AHI at week 52 was -29.3 events per hour (95% CI, -33.2 to -25.4) with tirzepatide and -5.5 events per hour (95% CI, -9.9 to -1.2) with placebo, for an estimated treatment difference of -23.8 events per hour (95% CI, -29.6 to -17.9) (P<0.001). Significant improvements in the measurements for all prespecified key secondary end points were observed with tirzepatide as compared with placebo. The most frequently reported adverse events with tirzepatide were gastrointestinal in nature and mostly mild to moderate in severity.

CONCLUSIONS:

Among persons with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide reduced the AHI, body weight, hypoxic burden, hsCRP concentration, and systolic blood pressure and improved sleep-related patient-reported outcomes. (Funded by Eli Lilly; SURMOUNT-OSA ClinicalTrials.gov number, NCT05412004.).
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: N Engl J Med Year: 2024 Document type: Article
Fulltext
Add to My VHL
Print
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: N Engl J Med Year: 2024 Document type: Article