Mounjaro (tirzepatide) approved in Pediatrics
Prepared on behalf of PES Drugs and Therapeutics Committee by, Evan Graber, DO, Emily Breidbart, MD, and Neha Patel, DO.
Based on results from the SURPASS-PEDS trial1, the FDA has approved Mounjaro (tirzepatide) for use in children and adolescents aged 10 years and older with type 2 diabetes. The medication is indicated as an adjunct to diet and exercise to help lower hemoglobin A1c.
The SURPASS-PEDS trial examined 99 patients aged 10 years and older with type 2 diabetes. At baseline, all patients were already receiving metformin, basal insulin, or both. Participants were randomized to receive either Mounjaro 5 mg weekly, Mounjaro 10 mg weekly, or placebo for 30 weeks. At end of study period, there was a statistically significant reduction in HgbA1c from baseline (mean decrease of 2%, pooled across both Mounjaro doses) and compared to placebo (mean difference of –1.8%, pooled across doses). BMI also decreased significantly from baseline (mean reduction 8.8 kg/m2) and relative to placebo (mean difference –8.3 kg/m2).
Reported side effects in pediatric patients are consistent with those observed in adults, although rates of vomiting, abdominal pain, and hypoglycemia appear to be higher in the pediatric population. The maximum pediatric dose is 10 mg weekly.
Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomized, double-blind, placebo-controlled, phase 3 trial
- Hannon, Tamara S et al. The Lancet, Volume 406, Issue 10511, 1484 – 1496
Prepared on behalf of PES Drugs and Therapeutics Committee by, Evan Graber, DO, Emily Breidbart, MD, and Neha Patel, DO.