international Journal of Obeasity Clinical Trial
Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: The SCALE Sleep Apnea randomized clinical trial
BACKGROUND: Obesity is strongly associated with prevalence of obstructive sleep apnea (OSA), and weight loss has been shown to reduce disease severity.
OBJECTIVE: To investigate whether liraglutide 3.0 mg reduces OSA severity compared to placebo using the primary endpoint of change in apnea–hypopnea index (AHI) after 32 weeks. Liraglutide’s weight loss efficacy was also examined.
SUBJECTS/METHODS: In this randomized, double-blind trial, non-diabetic participants with obesity who had moderate (AHI 15–29.9 events/h) or severe (AHI greater than or equal to30 events/h) OSA and were unwilling/unable to use continuous positive airway pressure therapy were randomized for 32 weeks to liraglutide 3.0 mg (n=180) or placebo (n=179), both as adjunct to diet (500 kcal/day deficit) and exercise. Baseline characteristics were similar between groups (mean age 48.5 years, males 71.9%, AHI 49.2 events/h, severe OSA 67.1%, body weight 117.6 kg, BMI 39.1 kg/m2, prediabetes 63.2%, HbA1c 5.7%).
RESULTS: After 32 weeks, the mean reduction in AHI was greater with liraglutide than with placebo (−12.2 vs −6.1 events/h, estimated treatment difference [ETD]: −6.1 events/h [95% CI, −11.0 to −1.2], P=0.0150). Liraglutide produced greater mean percentage weight loss compared with placebo (−5.7 vs −1.6%, ETD: −4.2% [95% CI, −5.2 to −3.1%], P<0.0001). A statistically significant association between the degree of weight loss and improvement in OSA endpoints (P<0.01, all) was demonstrated post hoc. Greater reductions in glycated hemoglobin (HbA1c) and systolic blood pressure (SBP) were seen with liraglutide versus placebo (both P<0.001). The safety profile of liraglutide 3.0 mg was similar to that seen with doses less than or equal to1.8 mg.
CONCLUSION: As an adjunct to diet and exercise, liraglutide 3.0 mg was generally well-tolerated and produced significantly greater reductions than placebo in AHI, body weight, SBP and HbA1c in participants with obesity and moderate/severe OSA. The results confirm that weight loss improves OSA-related parameters.
1Toronto Sleep Institute, MedSleep and University of Toronto, Toronto, ON, Canada
2School of Medicine, Temple University, Philadelphia, PA, USA
3Clinilabs and Sleep Disorders Institute, New York, NY, USA
4NeuroTrials Research, Atlanta, GA, USA
5Weill Cornell Medical College, New York, NY, USA
6Perelman School of Medicine, University of Pennsylvania, PA, USA
7Novo Nordisk A/S, Søborg, Denmark
8School of Medicine, Stanford University, Palo Alto, CA, USA
Correspondence: Dr A Blackman, MedSleep, Toronto Sleep Insitute, 586 Eglinton Avenue East, Suite 208, Toronto, Ontario M4P 1P2, Canada. E-mail: email@example.com
9A complete list of investigators in the Satiety and Clinical Adiposity—Liraglutide Evidence in non-diabetic and diabetic individuals (SCALE) study group is provided in the Online-Only Supplement
A Blackman1, G D Foster2, G Zammit3, R Rosenberg4, L Aronne5, T Wadden6, B Claudius7, C B Jensen7 and E Mignot8 on behalf of the SCALE study group
Received 7 August 2015; Revised 25 February 2016; Accepted 4 March 2016
Accepted article preview online 23 March 2016
REGISTRATION: clinicaltrials.gov Identifier—NCT01557166
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