Thursday, November 28

Should I Prescribe Liraglutide to a 6-Year-Old Patient With Obesity if FDA Approved?

Perspectives > > Second Opinions– I expect advantages surpassing prospective dangers in just a choose couple of circumstances

by Natalie Muth, MD, MPH, MBA, RDN October 6, 2024

Muth is a medical care pediatrician and weight problems medication professional.

As a pediatric weight problems medication expert, I have actually seen first-hand the advantages of GLP-1 receptor agonists in the treatment of teen weight problems. In specific, semaglutide (Wegovy) plus extensive health habits way of life treatment has actually enhanced comorbid health threat elements, exercise tolerance, sleep, body image, and confidence in a lot of the teenagers that I look after at a main care-based center.

For the lots of more youthful kids (under 12 years old) I see, no matter how serious the weight problems or considerable the obesity-related threat elements– like prediabetes, fatty liver, hypercholesterolemia, sleep apnea, or bullying and psychosocial distress– no medication choices are authorized to accompany extensive health habits way of life intervention.

That might all alter quickly.

The FDA is presently thinking about approval of liraglutide for the treatment of serious weight problems in kids ages 6-12. The evaluation begins the heels of a randomized trial released in the New England Journal of Medicine (NEJM) showing the security and effectiveness of liraglutide, contributed to way of life intervention, in dealing with serious weight problems in this client population.

Particularly, the multicenter trial of 82 kids discovered that over a 56-week treatment duration, kids treated with 3 mg of liraglutide plus behavioral intervention experienced a 5.8% decline in BMI compared to a 1.6% boost in the behavioral intervention just group. Of those kids who got liraglutide, 80% skilled intestinal adverse effects, the majority of which were moderate or moderate, compared to 54% in the placebo group.

The American Academy of Pediatrics’ Clinical Practice Guideline states we “might provide kids ages 8 through 11 years of age with weight problems weight loss pharmacotherapy, according to medication signs, dangers, and advantages, as an accessory to health habits and way of life treatment,” FDA approval is a required action before I will recommend weight problems medications in kids more youthful than 12 years.

Still, FDA approval is not a game-changer for me. As I think about the dangers versus advantages of liraglutide in this population, I prepare for advantages surpassing dangers in just a choose couple of scenarios. Here’s an introduction of what I view as the dangers and advantages:

Advantages:

  • Modest decrease in BMI percentile throughout the treatment duration.
  • Possible enhancements in metabolic threat elements. (Although the trial did not discover statistically considerable enhancements in high blood pressure or hemoglobin A1c, there were patterns towards enhancement.)
  • Possible enhancements in psychosocial threat elements connected with serious weight problems (based upon findings from research studies of teenagers taking weight problems medications), however this was not studied in the trial of liraglutide in kids 6-12.

Dangers:

  • Unidentified long-lasting security and effectiveness, consisting of effect on development and adult height.
  • Adverse effects,

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