Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study.
BACKGROUND
Acid suppression with a proton pump inhibitor is standard treatment for gastroesophageal reflux disease and erosive esophagitis in adults and increasingly is becoming first-line therapy for children aged 1-17 years. We evaluated endoscopic healing of erosive esophagitis with esomeprazole in young children with gastroesophageal reflux disease and described esophageal histology.


METHODS
Children aged 1-11 years with endoscopically or histologically confirmed gastroesophageal reflux disease were randomized to esomeprazole 5 or 10 mg daily (< 20 kg) or 10 or 20 mg daily (> or = 20 kg) for 8 weeks. Patients with erosive esophagitis underwent an endoscopy after 8 weeks to assess healing of erosions.


RESULTS
Of 109 patients, 49% had erosive esophagitis and 51% had histologic evidence of reflux esophagitis without erosive esophagitis. Of the 45 patients who had erosive esophagitis and underwent follow-up endoscopy, 89% experienced erosion resolution. Dilation of intercellular space was reported in 24% of patients with histologic examination.


CONCLUSIONS
Esomeprazole (0.2-1.0 mg/kg) effectively heals macroscopic and microscopic erosive esophagitis in this pediatric population with gastroesophageal reflux disease. Dilation of intercellular space may be an important histologic marker of erosive esophagitis in children.


BACKGROUND
D9614C00097; ClinicalTrials.gov identifier NCT00228527.
Tolia
Vasundhara
V
Wayne State University, Detroit, MI, USA. vasu.tolia@gmail.com.
Youssef
Nader N
NN
Gilger
Mark A
MA
Traxler
Barry
B
Illueca
Marta
M
D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D064098:Esomeprazole / Q000627:therapeutic use*; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000473:pathology; D004945:Esophagoscopy; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*
D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D064098:Esomeprazole