A review of omeprazole use in the treatment of acid-related disorders in children

Background: Acid peptic disease is a common problem, with a similar prevale nce of gastroesophageal reflux disease (GERD) in adults and children. The p resentation of GERD in infants and children varies from crying, irritabilit y, or sleep disturbance to feeding difficulties, vomiting, or rumination. H elicobacter pylori (HP)-related diseases and gastric and duodenal ulcers ar c:much more common in adults than in children, who are more likely to have gastritis or duodenitis. However, because HP infection is most likely acqui red in childhood, treatment of children with endoscopically documented acti ve HP disease may minimize the potential risk for peptic ulcer or gastric c ancer in adulthood, although this is yet to be proved. Objective: Omeprazole has been shown to be effective in the treatment of ac id-related diseases. This paper reviews the literature on the use and admin istration of omeprazole for the treatment of GERD, peptic ulcer disease, HP infection, and other acid-related conditions in children. Methods: Studies were identified through searches of MEDLINE(R) and Science Citation Index for the period 1986 to November 2000, and from the referenc e lists of identified articles. The search terms used included omeprazole, proton pump inhibitor (PPI), children, pediatrics, routes of administration , GERD, HP infection, esophagitis, and administration. In addition, the man ufacturer of omeprazole was asked for relevant unpublished information. Results: Marketed and extemporaneous formulations of omeprazole have been a dministered to children aged 2 months to Is years for the treatment of eros ive esophagitis, gastric ulcer, duodenal ulcer, HP infection, and related c onditions at dosages of 5 to 80 mg/d (0.2-3.5 mg/kg/d) for periods ranging from 14 days to 36 months with a low incidence of adverse effects. The init ial dose most consistently reported to heal esophagitis and provide relief of symptoms of GERD appears to he 1 mg/kg per day. Conclusions: In uncontrolled clinical trials and case reports to date, omep razole has been effective and well tolerated for the acute and chronic trea tment of esophageal and peptic ulcer disease in children, particularly thos e who had failed to respond to previous treatment with histamine,receptor a ntagonists. Should future longterm, controlled clinical trials in children demonstrate safety and efficacy, this PPI is likely to find a place in the armamentarium of pediatric pharmacotherapy.