PEDIATRIC GERD

INFORMATION

The primary objective of the pediatric development program was to evaluate the safety profile of NEXIUM in patients 1 to 11 years of age1

  • No new safety concerns were identified in patients 1 to 11 years of age1,2
  • No clinically important changes in hematology, clinical chemistry, urinalysis, vital signs, or physical examinations were reported (n=108).1

Experience with NEXIUM in pediatric patients with erosive esophagitis (EE)

    • In 34 pediatric patients with EE who had baseline and follow-up endoscopies, 86% had resolution of EE after 8 weeks on NEXIUM 10 mg or 20 mg daily3
    • Although most of the patients who had a follow-up endoscopy at the end of 8 weeks were healed, spontaneous healing cannot be ruled out2
GERD Graph
GERD Graph

Patients were considered healed if their final follow-up endoscopy showed no signs of erosions.3

aData from a Phase III, multicenter, randomized, double-blinded to dose, parallel-group study evaluating the safety and clinical outcome of NEXIUM in patients aged 1 to 11 years with GERD, treated once-daily with NEXIUM 5 mg, NEXIUM 10 mg, or NEXIUM 20 mg for 8 weeks.1,3,4 Dosing was determined by patient weight.3 A total of 109 patients of both sexes with endoscopically proven GERD were enrolled, with 101 patients completing the study. Of the 109 patients, 53 had EE at baseline (51 had Los Angeles Classification (LA) grade A and B, 1 had LA grade C, and 1 had LA grade D).1,3

bAmong all patients studied who had a follow-up endoscopy (n=45), overall resolution of EE was 89% (n=40) across varying grades of EE.3