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

Diabetes Obes Metab. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11.

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.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • African Continental Ancestry Group
  • Anti-Obesity Agents / administration & dosage
  • Anti-Obesity Agents / adverse effects
  • Anti-Obesity Agents / therapeutic use*
  • Asian Continental Ancestry Group
  • Body Mass Index
  • Combined Modality Therapy / adverse effects
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / ethnology
  • Diet, Reducing / ethnology
  • Double-Blind Method
  • European Continental Ancestry Group
  • Exercise
  • Female
  • Glycated Hemoglobin A / analysis
  • Humans
  • Hyperglycemia / ethnology
  • Hyperglycemia / prevention & control
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Liraglutide / administration & dosage
  • Liraglutide / adverse effects
  • Liraglutide / therapeutic use*
  • Male
  • Obesity / complications
  • Obesity / drug therapy*
  • Obesity / ethnology
  • Obesity / therapy
  • Overweight / complications
  • Overweight / drug therapy*
  • Overweight / ethnology
  • Overweight / therapy
  • Prediabetic State / blood
  • Prediabetic State / complications
  • Prediabetic State / drug therapy*
  • Prediabetic State / ethnology
  • Quality of Life
  • Weight Loss / drug effects
  • Weight Loss / ethnology

Substances

  • Anti-Obesity Agents
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • hemoglobin A1c protein, human
  • Liraglutide