Exenatide offers benefits beyond BMI reduction for teens with obesity
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Adolescents with obesity assigned the weekly GLP-1 receptor agonist exenatide for 6 months experienced a modest reduction in BMI along with improvements in several cardiometabolic markers, including 2-hour glucose and lipid profile, according to findings published in Pediatric Obesity.
“Safety, tolerability and efficacy of exenatide administered twice daily in children and adolescents with obesity have been assessed in a pilot study followed by a 3-month randomized controlled trial, where the drug reduced weight,” Anders Forslund, MD, PhD, an associate researcher in the department of women’s and children’s health at Uppsala University, Sweden, and colleagues wrote in the study background. “Extended-release formulation with administration of exenatide once weekly is available for type 2 diabetes treatment in adults. However, so far, there are no data on the efficacy, safety and tolerability of [an] extended-release GLP-1 analogue in the pediatric age group, neither for type 2 diabetes nor obesity.”
Forslund and colleagues analyzed data from 44 children and adolescents with a BMI standard deviation score (SDS) of 2 or greater or an age-adapted BMI of at least 30 kg/m2 (22 girls). Between September 2015 and September 2016, researchers randomly assigned participants to exenatide (Bydureon, AstraZeneca) 2 mg once-weekly extended release (n = 22; mean age, 15 years) or placebo injections (n = 22; mean age, 14 years) for 24 weeks, along with lifestyle intervention (four individual nutrition sessions plus four psychological sessions). All participants underwent oral glucose tolerance tests at baseline and 24 weeks.
Within the two study arms, seven participants in the exenatide group and four in the placebo group discontinued treatment early; all participants were included in the safe population.
Researchers found that exenatide was associated with a mean 0.09 reduction in BMI SDS (95% CI, –0.18 to 0), corresponding to a –3 kg reduction in weight (95% CI, –5.8 to –0.1), as well as a –0.83 kg/m² reduction in BMI (95% CI, –1.68 to 0.01) when compared with placebo. Participants assigned exenatide also experienced a mean 3.2 cm reduction in waist circumference (95% CI, –5.8 to 0.7) and reductions in subcutaneous adipose tissue, 2-hour glucose during the OGTT and total cholesterol without changes in liver fat content.
“Exenatide lowered liver fat content by 1.4%, meaning that approximately one-fifth of the liver fat content prior to the treatment had disappeared during the 24-week study period,” the researchers wrote. “This lowering was not significant (P = .06), however. Variation in the reduction became evident when liver fat content was displayed at the individual level.”
Adverse events were similar between groups, with more participants in the exenatide group reporting gastrointestinal adverse events vs. placebo.
“Given the burden of childhood obesity and the risk of developing complications including type 2 diabetes, the present study gives support for GLP-1 receptor agonists as attractive treatment alternatives for this patient group, where pharmacological alternatives are very limited,” the researchers wrote. “Future trials testing other GLP-1 receptor agonists in adolescents, which have shown clinically promising effects on reduction in BMI-SDS and other associated BMI metrics and measures of comorbidities, are warranted.” – by Regina Schaffer
Disclosures: AstraZeneca supplied the medication for this study. The authors report no relevant financial disclosures.
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