Efficacy and safety of oral pantoprazole 20 mg given once daily for reflux esophagitis in children.
OBJECTIVE
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.
Madrazo-de la Garza
Armando
A
Pediatric Gastroenterology Division, Hospital de Pediatría, Centro Medico Nacional Siglo XXI, I.M.S.S. Mexico City, Av. Cuauhtémoc #330 Col. de los doctores 06725, Mexico D.F. amadrazo@avantel.net
Dibildox
Miguel
M
Vargas
Antonio
A
Delgado
Juan
J
Gonzalez
Jorge
J
Yañez
Patricia
P
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000284:Administration, Oral; D000293:Adolescent; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D004947:Esophagus / Q000737:chemistry / Q000473:pathology; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration / Q000187:drug effects; D008297:Male; D009853:Omeprazole / Q000031:analogs & derivatives; D000077402:Pantoprazole; D012449:Safety; D013454:Sulfoxides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D013454:Sulfoxides; D000077402:Pantoprazole; D009853:Omeprazole