Dataset Information

Effect of liraglutide 3.0?mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial.

ABSTRACT: Obesity is strongly associated with prevalence of obstructive sleep apnea (OSA), and weight loss has been shown to reduce disease severity.To investigate whether liraglutide 3.0?mg reduces OSA severity compared with placebo using the primary end point of change in apnea-hypopnea index (AHI) after 32 weeks. Liraglutide's weight loss efficacy was also examined.In this randomized, double-blind trial, non-diabetic participants with obesity who had moderate (AHI 15-29.9 events?h(-1)) or severe (AHI ?30 events?h(-1)) 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(-1) deficit) and exercise. Baseline characteristics were similar between groups (mean age 48.5 years, males 71.9%, AHI 49.2 events?h(-1), severe OSA 67.1%, body weight 117.6?kg, body mass index 39.1?kg?m(-2), prediabetes 63.2%, HbA1c 5.7%).After 32 weeks, the mean reduction in AHI was greater with liraglutide than with placebo (-12.2 vs -6.1 events?h(-1), estimated treatment difference: -6.1 events?h(-1) (95% confidence interval (CI), -11.0 to -1.2), P=0.0150). Liraglutide produced greater mean percentage weight loss compared with placebo (-5.7% vs -1.6%, estimated treatment difference: -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 end points (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 ?1.8?mg.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.

SUBMITTER: Blackman A

PROVIDER: S-EPMC4973216 | biostudies-other | 2016 Aug

REPOSITORIES: biostudies-other

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Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial.

Blackman A A Foster G D GD Zammit G G Rosenberg R R Aronne L L Wadden T T Claudius B B Jensen C B CB Mignot E E

International journal of obesity (2005) 20160323 8

<h4>Background</h4>Obesity is strongly associated with prevalence of obstructive sleep apnea (OSA), and weight loss has been shown to reduce disease severity.<h4>Objective</h4>To investigate whether liraglutide 3.0 mg reduces OSA severity compared with placebo using the primary end point of change in apnea-hypopnea index (AHI) after 32 weeks. Liraglutide's weight loss efficacy was also examined.<h4>Subjects/methods</h4>In this randomized, double-blind trial, non-diabetic participants with obesit ...[more]

PMID: 27005405

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Project description:STUDY OBJECTIVES:To examine the level of physical activity (PA) before and following positive airway pressure (PAP) treatment in adults who have obstructive sleep apnea (OSA) with obesity versus without obesity. METHODS:Simultaneous waist accelerometer and wrist actigraphy recordings were obtained in 129 adults with obesity and 69 adults without obesity and who had OSA prior to and following 4 months of PAP therapy and in 52 patients in a control group. Primary PA measurements were average steps per day on waist accelerometry and average counts per minute (CPM) per day on wrist actigraphy. RESULTS:At baseline, participants with obesity and OSA exhibited fewer steps per day on waist accelerometer and fewer CPM per day on wrist actigraphy compared to participants without obesity and with OSA (despite similar apnea-hypopnea index between groups). Following PAP treatment, participants with OSA had modestly increased CPM per day on wrist actigraphy (17.69 [95% confidence interval (CI), 5.67-29.71], P = .005) and increased light PA time (0.26 [95% CI, 0.07-0.44] hours, P = .008) on waist accelerometer. Participants without obesity and with OSA had greater improvements in PA measures on average compared to participants with obesity and OSA, although the differences were not statistically significant. Weight increased following PAP treatment in the participants with obesity and OSA (1.71 [95% CI, 0.41-3.02] kg, P = .010) but was unchanged in the group without obesity (0.93 [95% CI, -0.89 to 2.76] kg, P = .311). CONCLUSIONS:Compared to study participants without obesity and with OSA, participants with obesity and OSA had reduced PA at baseline. PA increased significantly in participants without obesity, with OSA, and who were adherent to PAP treatment. Results indicate that treatment of OSA is unlikely to be associated with a change in PA in adults with obesity and OSA and help explain the absence of weight loss following PAP treatment in adults with OSA. CLINICAL TRIAL REGISTRATION:Registry: ClinicalTrials.gov, title: The Effects of Treating Obese and Lean Patients With Sleep Apnea (PISA), identifier: NCT01578031, URL: https://clinicaltrials.gov/ct2/show/NCT01578031.

Dataset Information

Effect of liraglutide 3.0?mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial.

Publications

Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial.

Similar Datasets

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