Omeprazole for treatment of chronic erosive esophagitis in children: a multicenter study of efficacy, safety, tolerability and dose requirements. International Pediatric Omeprazole Study Group.
OBJECTIVE
To determine the efficacy, safety, and tolerability of omeprazole in children and to determine the doses required to heal chronic, severe esophagitis.


METHODS
Open multicenter study in children aged 1 to 16 years with erosive 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 the healing dose.


RESULTS
At entry, two thirds of 57 patients who completed the study had esophagitis grade 3 or 4 (scale 0-4); some 50% had neurologic impairment or repaired 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 healing were 0.7 to 3.5 mg/kg/d: 0.7 mg/kg/d in 44% of patients and 1.4 mg/kg/d in another 28%. Healing dose correlated with grade of esophagitis but not 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 treatment of erosive esophagitis and symptoms of gastroesophageal reflux in children, including children in whom antireflux surgery or other medical therapy has failed. On a per-kilogram basis, the doses of omeprazole required to heal erosive esophagitis are much greater than those required for adults.
Hassall
E
E
Division of Gastroenterology, B.C. Children's Hospital, Vancouver, British Columbia, Canada.
Israel
D
D
Shepherd
R
R
Radke
M
M
Dalväg
A
A
Sköld
B
B
Junghard
O
O
Lundborg
P
P
D000293:Adolescent; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004942:Esophagitis, Peptic / Q000175:diagnosis / Q000188:drug therapy*; D005764:Gastroesophageal Reflux / Q000188:drug therapy; D006801:Humans; D007223:Infant; D009853:Omeprazole / Q000008:administration & dosage / Q000627:therapeutic use*; D010349:Patient Compliance; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D009853:Omeprazole