Long-term maintenance treatment with omeprazole in children with healed erosive oesophagitis: a prospective study

Aliment Pharmacol Ther. 2012 Feb;35(3):368-79. doi: 10.1111/j.1365-2036.2011.04950.x. Epub 2011 Dec 18.

Abstract

Background: Short-term studies show that PPIs heal erosive esophagitis in children. There are no prospective studies that examine long-term maintenance therapy of erosive esophagitis in children with and without underlying GERD-predisposing disorders.

Aim: To determine prospectively the dose of omeprazole needed to maintain remission of erosive oesophagitis and reflux symptoms in children.

Methods: Patients aged 1-16 years with healed erosive reflux oesophagitis after omeprazole treatment (0.7-3.5 mg/kg/day) entered a 21-month maintenance phase where they initially received half the dose of omeprazole required to heal. Endoscopy was performed after 3, 12 and 21 months. The omeprazole dose was increased if erosive oesophagitis or reflux symptoms recurred.

Results: A total of 46 patients entered the study and 32 completed it. Of these, 17 (53%) remained on the maintenance dose, 12 (38%) returned to their healing dose and 3 (9%) ended the study on a dose higher than their healing dose. Three-quarters of the completers (24/32) had no erosive oesophagitis relapse. Four patients (13%) had relapse of only erosive oesophagitis, 4 (13%) had relapse of erosive oesophagitis and symptoms, and 10 (31%) had only symptomatic relapse. Of the 46 patients, 48% had GERD-predisposing disorders (neurological impairment or oesophageal atresia). Overall, 62.5% (5/8) of patients who had an erosive oesophagitis relapse had a GERD-predisposing disorder versus 33.3% (8/24) of those who did not.

Conclusions: Remission of erosive oesophagitis is maintained with omeprazole treatment for at least 21 months in most children aged 1-16 years, and the drug is well tolerated. To maintain remission, some 60% of patients require more than half the dose required for healing. In children with GERD-predisposing conditions, GERD is often chronic and relapsing, and requires long-term management.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Child
  • Child, Preschool
  • Dose-Response Relationship, Drug
  • Enzyme Inhibitors / administration & dosage*
  • Esophagitis / drug therapy*
  • Female
  • Humans
  • Infant
  • Long-Term Care
  • Male
  • Omeprazole / administration & dosage*
  • Prospective Studies
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome

Substances

  • Enzyme Inhibitors
  • Omeprazole