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Long-term maintenance treatment with omeprazole in children with healed erosive oesophagitis: a prospective study
E Hassall1, R Shepherd, S Koletzko
1Division of Gastroenterology, British Columbia Children's Hospital/University of British Columbia, Vancouver, Canada. hassale@sutterhealth.org
Insights
Long-term omeprazole effectively maintains remission of erosive esophagitis in children. Most children require more than half their healing dose for sustained symptom control and healing.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Clinical Therapeutics
Background:
- Proton pump inhibitors (PPIs) demonstrate short-term efficacy in healing pediatric erosive esophagitis.
- Prospective data on long-term maintenance therapy for pediatric erosive esophagitis, particularly with GERD-predisposing conditions, are lacking.
Purpose of the Study:
- To prospectively determine the optimal omeprazole dosage for maintaining remission of erosive esophagitis and associated reflux symptoms in children.
Main Methods:
- A 21-month maintenance phase involving 46 children (aged 1-16) with healed erosive esophagitis.
- Initial maintenance dose was half the healing dose, with adjustments based on endoscopic and symptomatic recurrence.
- Endoscopic evaluations at 3, 12, and 21 months.
Main Results:
- 53% of patients maintained the reduced omeprazole dose, 38% returned to their healing dose, and 9% required a higher dose.
- 75% of completers (32/46) achieved remission; 25% experienced relapse (esophagitis, symptoms, or both).
- Patients with GERD-predisposing disorders had a higher rate of erosive esophagitis relapse (62.5% vs. 33.3%).
Conclusions:
- Omeprazole effectively maintains remission of pediatric erosive esophagitis for at least 21 months in the majority of patients.
- Approximately 60% of children need more than half their healing dose to maintain remission.
- Children with GERD-predisposing conditions often have chronic, relapsing GERD requiring extended management.
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.
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