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The FDA has approved once weekly semaglutide therapy for adolescents ages 12 years old and up.
The results of the study showed the following:
Mean percentage change in body mass index (BMI) at week 68 was the primary endpoint of the trial. The mean change in BMI was a 16.1% decrease for the semaglutide group compared to a 0.6% increase for the placebo group.
A BMI reduction of 5% or more was the secondary endpoint of the trial. This was met by 77% of patients taking semaglutide and 20% of patients taking placebo.
Adverse reactions in adolescents taking semaglutide matched those of adults, with the most common reactions including headache, abdominal pain, nausea, vomiting, and diarrhea. Adolescents saw an increased incidence of gallbladder problems compared to adults, including gallstones, low blood pressure, rash, and itching.
The recommended dose of semaglutide in pediatric patients is 2.4 mg, and it should be used alongside a reduced-calorie meal plan and increased physical activity to treat obesity. Semaglutide should not be taken alongside other semaglutide-containing products or GLP-1 receptors.
Reference: Once-Weekly Semaglutide in Adolescents with Obesity
Authors: Daniel Weghuber, M.D., Timothy Barrett, Ph.D., Margarita Barrientos-Pérez, M.D., Inge Gies, Ph.D., Dan Hesse, Ph.D., Ole K. Jeppesen, M.Sc., Aaron S. Kelly, Ph.D., Lucy D. Mastrandrea, M.D., Rasmus Sørrig, Ph.D., and Silva Arslanian, M.D.
Published November 2, 2022 N Engl J Med 2022;387:2245-2257 DOI: 10.1056/NEJMoa2208601 VOL. 387 NO. 24
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