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Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized,
Vasundhara Tolia1, Nader N Youssef, Mark A Gilger
1*Wayne State University, Detroit, MI †Atlantic Health, Morristown, NJ ‡Baylor College of Medicine, Houston, TX §AstraZeneca LP, Wilmington, DE.
Insights
Esomeprazole effectively healed erosive esophagitis in young children with gastroesophageal reflux disease. Histologic examination revealed dilation of intercellular space in a quarter of patients, suggesting it as a potential marker.
Area of Science:
- Pediatric gastroenterology
- Gastrointestinal pharmacology
- Esophageal pathology
Background:
- Proton pump inhibitors are standard for gastroesophageal reflux disease (GERD) in adults.
- Acid suppression is increasingly used for children aged 1-17 years.
- This study focuses on young children with GERD and erosive esophagitis.
Purpose of the Study:
- Evaluate endoscopic healing of erosive esophagitis with esomeprazole in young children.
- Describe esophageal histology in pediatric GERD patients.
- Assess the efficacy of esomeprazole in healing GERD-related esophageal damage.
Main Methods:
- Children aged 1-11 years with confirmed GERD were randomized.
- Doses of esomeprazole varied by weight (5-20 mg daily).
- Follow-up endoscopy assessed healing after 8 weeks of treatment.
Main Results:
- 49% of 109 patients had erosive esophagitis.
- 89% of patients with erosive esophagitis showed erosion resolution.
- Dilation of intercellular space was observed in 24% of patients histologically.
Conclusions:
- Esomeprazole (0.2-1.0 mg/kg) effectively heals erosive esophagitis in pediatric GERD.
- Macroscopic and microscopic healing was achieved.
- Dilation of intercellular space may indicate erosive esophagitis in children.
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 (≥ 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.

