Omeprazole for treatment of chronic erosive esophagitis in children: A multicenter study of efficacy, safety, tolerability and dose requirements

Objectives: To determine the efficacy safety, and tolerability of omeprazol e in children and to determine the doses required to heal chronic, severe e sophagitis. Study design: Open multicenter study in children aged 1 to 16 years with er osive reflux esophagitis. The healing dose of omeprazole used was that with which the duration of acid reflux was <6% of a 24-hour intraesophageal pH Study. Follow-up endoscopy was performed after 3 months of treatment with t he healing dose. Results: At entry, two thirds of 57 patients who completed the study had es ophagitis grade 3 or 4 (scale 0-4); some 50% had neurologic impairment or r epaired esophageal atresia. Of the 57 patients, 54 healed; 3 did not. heal and left the study, and 3 healed with a second course. Doses required for h ealing were 0.7 to 3.5 mg/kg/d: 0.7 mg/kg/d in 44% of patients and 1.4 mg/k g/d in another 28%. Healing dose correlated with grade of esophagitis but n ot with age or underlying disease, Reflux symptoms improved dramatically in almost all of the 57 patients, including the unhealed patients. Conclusions: Omeprazole is well tolerated, highly effective, and safe for t reatment of erosive esophagitis and symptoms of gastroesophageal reflux in children, including children in whom antireflux surgery or other medical th erapy has failed. On a per-kilogram basis, the doses of omeprazole required to heal erosive esophagitis are much greater than those required for adult s.