Abstract
In two previous, separate clinical trials, we demonstrated significant reductions in body mass index (BMI) with exenatide in adolescents with severe obesity. In the present study, we pooled data from these near identical trials to evaluate factors that may predict BMI reduction at 3 months. Data from 32 patients (mean age 14.3±2.2 years; 69% female; mean BMI 39.8±5.8kgm-2) were included. Exenatide treatment consisted of 5mcg twice daily for 1 month, followed by an increase to 10mcg twice daily for 2 additional months. Predictor variables included baseline BMI, BMI percent change at 1 month, incidence of nausea or vomiting and baseline appetite and satiety measures. Treatment effects of percent change in BMI from baseline were estimated within predictor subgroups using generalized estimating equations with exchangeable working correlation and robust variance estimation for confidence intervals and P-values to account for paired observations. The pooled data treatment effect on absolute BMI at 3 months was -3.42% (95% confidence interval: -5.41%, -1.42%) compared to placebo. Within treated participants, appetite at baseline (treatment effect in high [-4.28%] vs. low [1.02%], P=0.028) and sex (treatment effect in female [-4.78%] vs. male [0.76%], P=0.007) were significant predictors of change in BMI at 3 months. Baseline BMI, BMI percent change at 1 month, age, incidence of nausea, vomiting, or other gastrointestinal symptoms and satiety scores did not predict 3-month responses. Sex and measures of appetite may serve as useful predictors of glucagon-like peptide-1 receptor agonist treatment response among adolescents with severe obesity.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 73-78 |
| Number of pages | 6 |
| Journal | Clinical obesity |
| Volume | 6 |
| Issue number | 1 |
| DOIs | |
| State | Published - Feb 1 2016 |
Bibliographical note
Funding Information:Funding for this study was provided by the Minnesota Obesity Center (NIH Grant P30DK050456 NORC), a Community Health Collaborative Grant from the University of Minnesota Clinical and Translational Science Institute, and from Award Number UL1TR000114 from the National Center for Advancing Translational Sciences. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Advancing Translational Sciences, or the National Institutes of Health. Study drug and placebo were generously provided by Amylin Pharmaceuticals, Inc. The authors would like to thank Angela Fitch, M. D., and Betsy Schwartz, M. D., for assistance in recruitment, and Andrea Metzig for assistance in study coordination.
Funding Information:
Funding for this study was provided by the Minnesota Obesity Center (NIH Grant P30DK050456 NORC), a Community Health Collaborative Grant from the University of Minnesota Clinical and Translational Science Institute, and from Award Number UL1TR000114 from the National Center for Advancing Translational Sciences. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Advancing Translational Sciences, or the National Institutes of Health. Study drug and placebo were generously provided by Amylin Pharmaceuticals, Inc. The authors would like to thank Angela Fitch, M. D., and Betsy Schwartz, M. D., for assistance in recruitment, and Andrea Metzig for assistance in study coordination.
Publisher Copyright:
© 2016 World Obesity.
Keywords
- GLP-1 agonist
- Paediatrics
- Personalized medicine
- Severe obesity
