Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials

J Ard, A Cannon, C E Lewis, H Lofton, T Vang Skjøth, B Stevenin, X Pi-Sunyer, J Ard, A Cannon, C E Lewis, H Lofton, T Vang Skjøth, B Stevenin, X Pi-Sunyer

Abstract

The efficacy and safety of liraglutide 3.0 mg versus placebo, as adjunct to diet and exercise, was evaluated in racial subgroups. This post hoc analysis of pooled data from five double-blind randomized, placebo-controlled trials was conducted in 5325 adults with either a body mass index (BMI) ≥27 kg/m(2) plus ≥1 comorbidity or a BMI ≥30 kg/m(2). Statistical interaction tests evaluated possible treatment effect differences between racial subgroups: white (4496, 84.4%), black/African-American (550, 10.3%), Asian (168, 3.2%) and other (111, 2.1%). Effects of liraglutide 3.0 mg on weight loss, associated metabolic effects and safety profile were generally consistent across racial subgroups. All achieved statistically significant mean weight loss at end-of-treatment with liraglutide 3.0 mg versus placebo: white 7.7% versus 2.3%, black/African-American 6.3% versus 1.4%, Asian 6.3% versus 2.5%, other 7.3% versus 0.49%. Treatment effects on weight and cardiovascular risk markers generally showed no dependence on race (interaction test p > 0.05). Adverse events were similar across racial subgroups.

Keywords: antiobesity drug; clinical trial; glucagon-like peptide-1 analogue; liraglutide; obesity therapy; randomized trial.

© 2016 John Wiley & Sons Ltd.

Figures

Figure 1
Figure 1
Body weight loss in different racial subgroups treated with liraglutide 3.0 mg or placebo presented as mean relative weight loss from baseline to end of treatment (A) and (B) the proportion of participants achieving ≥5%, >10%, and >15% weight loss. Data are estimated least squares (LS) means from an analysis of covariance (ancova) model (A) and estimated proportions from a logistic regression model (B) for the full analysis set (all exposed individuals with at least one post‐baseline efficacy assessment) with last observation carried forward imputation. The ‘Other’ subgroup includes American Indian or Alaska Native, Native Hawaiian people or other Pacific Islanders, and other. BAA, Black/African‐American; CI, confidence interval; ETD, estimated treatment difference; N, number of individuals contributing to the analysis; OR, odds ratio. *Statistically significant treatment difference of p < 0.02 versus placebo. †As no participants in the placebo group achieved the weight loss target, the treatment estimate was infinity.

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