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SCALE trials: Saxenda promotes weight loss, improves health-related quality of life
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NASHVILLE, Tenn. - The weight-loss drug Saxenda offers similar benefits across races and was shown to improve health-related quality of life, including physical function and mental health, according to study findings presented here.
In a series of studies analyzing data from the Satiety and Clinical Adiposity - Liraglutide Evidence (SCALE) trials, researchers also demonstrated that adverse gastrointestinal events from Saxenda (liraglutide, Novo Nordisk), including nausea and vomiting, did not affect weight loss.
Ronette L. Kolotkin, PhD , owner of Quality of Life Consulting, Durham, North Carolina, and colleagues at other institutions analyzed data from 3,731 adults (79% women; mean age, 45 years; mean baseline BMI, 38 kg/m2) participating in the SCALE Obesity and Prediabetes study. Participants were randomly assigned 2:1 to 3 mg once-daily liraglutide (n = 2,487) or placebo (n = 1,244) while asked to adhere to a 500-kcal/day diet and complete a 150-minute/week exercise program. Researchers used impact of weight on quality of life (IWQOL-Lite) and 36-item short-form (SF-36) questionnaires to assess health-related quality of life outcomes at baseline, 6 months and 1 year.
Ronette L. Kolotkin
Patients assigned liraglutide had significantly greater improvements in IWQOL-Lite total scores (10.6 ± 13.3) vs. those assigned placebo (7.6 ± 12.8). Physical and mental component summary scores from the SF-36 questionnaire also were higher for patients assigned liraglutide (physical, 3.6 ± 6.8; mental, 0.2 ± 8.1) vs. placebo (physical, 2.2 ± 7.7; mental, -0.9 ± 9.1). Greater weight loss from baseline was observed with liraglutide compared with placebo (-8 ± 6.7% vs. -2.6 ± 5.7%).
“Use of liraglutide 3 mg, in addition to diet and exercise, was associated with clinically meaningful improvements in physical domains of health-related quality of life vs. placebo,” the researchers wrote.
In a separate study, Michael Lean, MA, MB, FRCP, FRCPS, chair of human nutrition at University of Glasgow, United Kingdom, and colleagues from other institutions used the same SCALE Obesity and Prediabetes data to analyze associations between gastrointestinal adverse effects and weight loss with liraglutide vs. placebo. Patients assigned liraglutide reported more adverse gastrointestinal events (68.3%) compared with those assigned a placebo (40.3%). The most common adverse effects reported by those assigned liraglutide and placebo, respectively, were nausea (40.2% vs. 14.7%), diarrhea (20.9% vs. 9.3%), constipation (20% vs. 8.7%) and vomiting (16.3% vs. 4.1%), most occurring within the first 16 weeks of treatment, according to researchers.
Researchers saw no significant difference in weight loss between participants who did or did not experience nausea or vomiting, regardless of treatment.
“Although those experiencing [no gastrointestinal adverse events] appeared to perform slightly better than the other groups, this may be explained by the higher withdrawal rate as the number of [gastrointestinal adverse events] increase,” the researchers wrote.
In a separate, post-hoc analysis of pooled data from a 52-week phase 2 trial and the four phase 3 SCALE trials (three lasting 56 weeks; one lasting 32 weeks), researchers compared the efficacy and safety of liraglutide vs. placebo in different racial subgroups: white (n = 4,945), black (n = 580), Asian (n = 172) and other (n = 116). Across subgroups, most participants in the randomized, double blind trials were women (60% to 80%) and mean age ranged from 41 to 48 years. Participants across all subgroups assigned liraglutide experienced greater mean weight loss from baseline until end of treatment compared with those assigned placebo (white: -7.74% vs. -2.35%; black: -6.29% vs. -1.36%; Asian: -6.29% vs. -2.52%; other: -7.31% vs. -0.49%). In each subgroup, more participants lost more than 5% of their baseline body weight with liraglutide (range, 52% to 62%) vs. placebo (8.7% to 25%) and more than 10% of their baseline body weight with liraglutide (22% to 33%) compared with those assigned placebo (0% to 8.9%, P < .02 for all).
A separate post-hoc analysis pulling from the same randomized, double blind trails compared the effects of liraglutide in Hispanic patients both with and without type 2 diabetes (n = 551; 76% women; mean age, 42 years; mean BMI, 37.1 kg/m2) with effects in non-Hispanic patients (n = 4,790; 70% women; mean age, 48 years; mean BMI, 38 kg/m2). Both subgroups achieved clinically significant and similar weight loss with liraglutide vs. placebo. Hispanic participants assigned liraglutide lost 6.95% of their body weight; Hispanic patients assigned placebo lost 1.54% of their body weight. Non-Hispanic participants assigned liraglutide lost 7.54% of their body weight, whereas non-Hispanic patients assigned placebo lost 2.25% of their body weight. - by Regina Schaffer
Reference s :
Ard J, et al. Abstract #612.
Kolotkin R, et al. Abstract #610.
Lean M, et al. Abstract #611.
O’Neil P, et al.; Abstract #615. All presented at: AACE 24th Annual Scientific & Clinical Congress; May 13-17, 2015; Nashville, Tenn.
Disclosure: Researchers in all studies reported financial support from Novo Nordisk.