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

doi:10.1111/dom.12632

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.

Authors

J Ard¹, A Cannon², C E Lewis³, H Lofton⁴, T Vang Skjøth⁵, B Stevenin⁶, X Pi-Sunyer⁷

Affiliations

¹ Wake Forest School of Medicine, Wake Forest Baptist Medical Center, Winston-Salem, NC, USA.
² Endocrine Metabolic Associates, Philadelphia, PA, USA.
³ Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
⁴ New York University School of Medicine, New York, NY, USA.
⁵ Novo Nordisk A/S, Søborg, Denmark.
⁶ Novo Nordisk Inc, Plainsboro, NJ, USA.
⁷ Columbia University, New York, NY, USA.

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
Anti-Obesity Agents / administration & dosage
Anti-Obesity Agents / adverse effects
Anti-Obesity Agents / therapeutic use*
Asian People
Black People
Black or African American
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
Exercise
Female
Glycated Hemoglobin / 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
White People

Substances

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