Randomised Trial Finds Obesity Medication Liraglutide Safe and Effective For Children Under 12
The obesity medication liraglutide is safe and effective in children aged 6 to <12 years, new research presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and published simultaneously in the New England Journal of Medicine (NEJM), has found.
Childen aged six to <12 years who took liraglutide for just over a year experienced a reduction in BMI of 7.4% compared to placebo and experienced improvements in blood pressure and blood sugar control.
The results of the SCALE Kids trial, the first study to examine the safety and efficacy of liraglutide in the paediatric population, offer hope that children who are living with obesity can lead healthier, more productive lives, say the researchers.
Lead author Professor Claudia Fox, of the Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis, USA, says: “Obesity is the most common chronic disease of childhood. Left untreated, obesity in childhood almost universally persists into adulthood and is associated with significant ill health, including diabetes and cardiovascular disease, and for some, premature death. Early intervention is therefore critical.
“However, effective treatment options to date are limited. The backbone of obesity treatment is lifestyle therapy – changes in diet and physical activity – but when used alone, the effect is modest and, as yet, no medication is approved for the treatment of general obesity in children who are younger than 12.
“Liraglutide is approved as an adjunct to lifestyle therapy in adults and adolescents with obesity and, in this study, we explored its safety and efficacy in under-12s.”
The phase 3 study, which was funded by liraglutide maker Novo Nordisk, involved 82 children (53.7% male) aged 6 to <12 years. At baseline, average age was 10 years, BMI was 31.0 kg/m2 and body weight was 70.2 kg (11st 1lb). 54.9% of children had ≥1 obesity-related complication, such as insulin resistance or early puberty.
56 children received daily injections of liraglutide (3mg or maximum tolerated dose) and 26 received weekly injections of placebo for 56 weeks. All of the participants received individualised counselling at every visit to encourage adherence to a healthy diet and regular physical activity (with the aim of doing 60 minutes a day of moderate to high intensity exercise).
At the end of the treatment period, the mean change in BMI was −5.8% for liraglutide and +1.6% for placebo – a difference of 7.4%.
Mean change in body weight was +1.6% for liraglutide and +10% for placebo – a difference of 8.4%.
A reduction in BMI of at least 5% was observed in 46.2% of children receiving liraglutide and 8.7% receiving placebo.
Children of this age are constantly growing and so body weight would be expected to increase over the course of a year. BMI takes into account height, as well as weight, and so is more informative, say the researchers.
Professor Fox says: “Although there is no consensus on the definition of a clinically meaningful BMI reduction in children, a 5% reduction has previously been shown to be associated with improvement in some obesity-related health conditions.
“In our study, diastolic blood pressure and haemoglobin A1c [HbA1c], a measure of blood sugar control, improved more in children receiving liraglutide than in those receiving the placebo.”
Professor Fox adds: “The results of this study offer considerable promise to children living with obesity.
“To date, children have had virtually no options for treating obesity. They have been told to ‘try harder’ with diet and exercise.
“Now with the possibility of a medication that addresses the underlying physiology of obesity, there is hope that children living with obesity can live healthier, more productive lives.”
Reference: Fox, C. K., Barrientos-Pérez, M., Bomberg, E. M., Dcruz, J., Gies, I., Harder-Lauridsen, N. M., Jalaludin, M. Y., Sahu, K., Weimers, P., Zueger, T., & Arslanian, S. (Year). Liraglutide for children 6 to <12 years of age with obesity — A randomized trial. The New England Journal of Medicine.
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