EFFICACY AND SAFETY OF OMEPRAZOLE FOR SEVERE GASTROESOPHAGEAL REFLUX IN CHILDREN

Omeprazole, a potent inhibitor of acid secretion, is effective in adul ts with severe gastroesophageal reflux, but no such data are available on children. We studied 15 children in whom treatment with histamine (type 2) blockers and prokinetic agents had failed; 4 had also had one or more fundoplications. Their ages were 0.8 to 17 years (mean, 8.1 y ears) and weights were 7.5 to 30.7 kg (mean, 18.6 kg). Of the 15 child ren, 8 were neurologically handicapped. All patients had endoscopic an d histologic evidence of esophagitis; most had esophagitis grade 3 to 4. Patients were initially given omeprazole at 10 to 20 mg; the dose w as titrated upward until results of a subsequent 24-hour intraesophage al pH study was normal. Symptoms and signs abated and evidence of esop hagitis diminished in all patients. Omeprazole was given for periods o f 5.5 to 26 months (mean, 12.2 months). The effective total dose was 2 0 to 40 mg (0.7 to 3.3 mg/kg) in 11 patients, 10 mg (0.7 mg/kg) in 1 p atient, and 60 mg (1.9 to 2.4 mg/kg) in 3 patients. The dosage range w as 0.7 to 3.3 to mg/kg per day (mean, 1.9 mg/kg). Mildly elevated tran saminase values in 7 patients and elevated fasting gastrin levels in 1 1 patients were present; in 6 of the 11, gastrin levels were 3 to 5.5 times the upper limit of normal. We found omeprazole to be highly effe ctive in this group of patients with severe esophagitis refractory to other measures. We recommend a starting dose of 0.7 mg/kg as a single morning dose; the adequacy of reflux control is then determined by fol low-up 24-hour intraesophageal pH studies. Omeprazole appears to be sa fe for short-term use, but further studies are needed to assess long-t erm safety because the significance of chronically elevated gastrin le vels in children is unknown.