Prevention of erosive oesophagitis relapse with pantoprazole.
OBJECTIVE
To compare the safety and efficacy of pantoprazole and ranitidine in maintaining erosive oesophagitis healing.


METHODS
Gastro-oesophageal reflux disease patients (349) with endoscopically documented healed erosive oesophagitis (grade 0 or 1) were randomly assigned to receive pantoprazole (10, 20 or 40 mg/q.d.s.) or ranitidine (150 mg/b.d.). Erosive oesophagitis status was assessed endoscopically at months 1, 3, 6 and 12 or when relapse symptoms appeared (relapse = reappearance of erosive oesophagitis grade 2 within 12 months). Symptom-free days were also assessed.


RESULTS
Pantoprazole 20- and 40-mg were significantly more effective than ranitidine in maintaining healing regardless of initial erosive oesophagitis grade. Response was dose-related. After 12 months 78, 55, 46 and 21% of patients remained healed (40-, 20-, 10-mg pantoprazole and ranitidine). Pantoprazole 40-mg produced significantly more symptom-free days (83%) than ranitidine (58%). Heartburn-free days/nights were significantly higher with pantoprazole 40-mg (92 and 93%) than ranitidine (73 and 77%). The most frequent reason for discontinuation, unsatisfactory efficacy, occurred most often with ranitidine (P < 0.001).


CONCLUSIONS
Once-daily pantoprazole therapy prevented relapse of healed erosive oesophagitis more effectively than ranitidine and with fewer heartburn days. Response to pantoprazole was dose-related. Pantoprazole 40-mg was the most effective regimen and consistent in maintaining erosive oesophagitis healing with a good safety and tolerability profile.
Richter
J E
JE
Department of Gastroenterology and Hepatology, The Cleveland Clinic Foundation, Cleveland, OH 44195, USA. richtej@ccf.org
Fraga
P
P
Mack
M
M
Sabesin
S M
SM
Bochenek
W
W
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D004311:Double-Blind Method; D004941:Esophagitis / Q000517:prevention & control*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000077402:Pantoprazole; D055502:Secondary Prevention; D013454:Sulfoxides / Q000627:therapeutic use*; D016019:Survival Analysis
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D013454:Sulfoxides; D000077402:Pantoprazole; D009853:Omeprazole