Open AccessRESEARCH ARTICLE
© 2010 Tolia et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.
Esomeprazole for the treatment of erosiveesophagitis in children: an international,multicenter, randomized, parallel-group,double-blind (for dose) study
Acid suppression with a proton pump inhibitor is standard treatment for gastroesophageal reflux diseaseand erosive esophagitis in adults and increasingly is becoming first-line therapy for children aged 1-17 years. Weevaluated endoscopic healing of erosive esophagitis with esomeprazole in young children with gastroesophagealreflux disease and described esophageal histology.
Children aged 1-11 years with endoscopically or histologically confirmed gastroesophageal reflux diseasewere randomized to esomeprazole 5 or 10 mg daily (< 20 kg) or 10 or 20 mg daily (≥ 20 kg) for 8 weeks. Patients witherosive esophagitis underwent an endoscopy after 8 weeks to assess healing of erosions.
Of 109 patients, 49% had erosive esophagitis and 51% had histologic evidence of reflux esophagitis withouterosive 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 histologicexamination.
Esomeprazole (0.2-1.0 mg/kg) effectively heals macroscopic and microscopic erosive esophagitis in thispediatric population with gastroesophageal reflux disease. Dilation of intercellular space may be an importanthistologic marker of erosive esophagitis in children.
D9614C00097; ClinicalTrials.gov identifier NCT00228527.
Gastroesophageal reflux disease (GERD) increasingly isrecognized in young children. A recent retrospectivepopulation-based cohort study in Rochester, MN, foundthat the incidence of GERD in children aged < 5 years was0.9/1,000 person-years . Data on the prevalence andseverity of erosive esophagitis (EE) in young children arelimited. The prevalence of endoscopy- and biopsy-provenEE in one study was 29% in 209 patients with GERD aged18 months to 10 years who had no neurologic abnormali-ties or congenital esophageal anomalies . A retrospec-tive review of the Pediatric Endoscopy Database System-Clinical Outcomes Research Initiative (PEDS-CORI)demonstrated that, of 7,188 children aged ≤ 18 years whounderwent endoscopy, 12.4% had EE .Although endoscopy is a valuable tool in the diagnosisof pediatric GERD and EE that provides macroscopic evi-dence of erosions, histology is important because abnor-malities may be present without visible lesions onendoscopy. The North American Society for PediatricGastroenterology, Hepatology, and Nutrition(NASPGHAN) guidelines for pediatric GERD recom-mend esophageal biopsy in conjunction with diagnosticendoscopy . If erosions are identified, histology is notconsidered mandatory for routine diagnosis of GERD. Onhistology, esophagitis is diagnosed by the presence of epi-thelial hyperplasia, intraepithelial inflammation, vasculardilatation in papillae, balloon cells, and ulceration .Dilated intercellular spaces have been described as an
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Wayne State University, Detroit, MI, USA
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