Objectives: To investigate the efficacy and safety of oral pantoprazole, 20 mg (0.5 to 1.0 mg/kg/day) once daily for 28 days, in pediatric patients with reflux esophagitis.
Methods: Patients in this study (n = 15; 6 to 13 years old, 9 boys) had reflux esophagitis grade Ic or II (Vandenplas classification). The efficacy of pantoprazole to reduce esophageal acid exposure time (pH < 4), reduce the number and duration of reflux episodes, and to increase the percentage of time with gastric pH > 3 was assessed by continuous 24-hour pH monitoring. The intensity of 5 common symptoms of esophagitis was scored before and after treatment on a 4-point scale. Esophagitis was assessed at baseline and after treatment by visual inspection and by the histology of biopsies from the distal third of the esophagus.
Results: Before treatment, the median percentage of time with intra-esophageal pH <4 was 9.3%. After 28 days of therapy with pantoprazole, this value decreased to 2.7% (P = 0.0006). The median percentage of time with intragastric pH > 3 increased from 21% at baseline to 39% on day 28 of therapy (P = 0.005). After 28 days of treatment, all patients experienced at least partial relief from reflux symptoms. Endoscopically confirmed healing of esophagitis was seen in 47% of children (Savary-Miller classification). Histologic evidence of healing was not observed. Median serum gastrin levels were slightly elevated over baseline levels (from 74 pg/ml to 93 pg/ml). In one patient there was a transient elevation of serum GOT and GPT during treatment.
Conclusions: Oral pantoprazole 20 mg daily provided gastric acid control in 15 pediatric patients with reflux esophagitis with partial clinical improvement of symptoms after 28 days of treatment. Pantoprazole was safe and well tolerated.