Comparison of the efficacy of pantoprazole vs. nizatidine in the treatment of erosive oesophagitis: a randomized, active-controlled, double-blind study.
BACKGROUND
Pantoprazole is a proton pump inhibitor approved for the treatment of erosive oesophagitis and gastro-oesophageal reflux disease.


OBJECTIVE
To compare the efficacy and safety of pantoprazole vs. nizatidine for the treatment of symptomatic gastro-oesophageal reflux disease and endoscopically documented erosive oesophagitis (grade > or = 2).


METHODS
A multicentre, double-blind, randomized, active-controlled study (221 patients) was performed to compare 20 and 40 mg pantoprazole daily with nizatidine 150 mg b.d. (maximum, 8 weeks). The primary end-point was endoscopic healing of erosive oesophagitis (grade 1 or 0). The secondary end-point was symptomatic improvement.


RESULTS
Healing averaged 61%, 64% and 22% for pantoprazole 20 mg, pantoprazole 40 mg and nizatidine 150 mg, respectively, at 4 weeks, and 79%, 83% and 41% at 8 weeks (P < 0.05, differences between groups at both points). Starting on day 1 of symptom assessment, significantly fewer pantoprazole-treated patients reported night-time heartburn and regurgitation compared with nizatidine-treated patients. Symptoms of gastro-oesophageal reflux disease were completely eliminated in 68% and 65% of patients in the pantoprazole 20-mg and 40-mg groups and in 28% of patients in the nizatidine group at study completion. The difference between each pantoprazole group and the nizatidine group was significant (P < 0.05).


CONCLUSIONS
Pantoprazole, at single daily doses of 20 mg and 40 mg for up to 8 weeks, provides more rapid relief of symptoms and superior healing of erosive oesophagitis than nizatidine 150 mg b.d., and is well tolerated.
Kovacs
T O G
TO
CURE/VAGLAHS, Los Angeles, CA, USA.
Wilcox
C M
CM
DeVault
K
K
Miska
D
D
Bochenek
W
W
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D016567:Nizatidine / Q000009:adverse effects / Q000627:therapeutic use*; D009853:Omeprazole / Q000031:analogs & derivatives; D000077402:Pantoprazole; D054328:Proton Pump Inhibitors; D012720:Severity of Illness Index; D013454:Sulfoxides / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D004791:Enzyme Inhibitors; D054328:Proton Pump Inhibitors; D013454:Sulfoxides; D000077402:Pantoprazole; D009853:Omeprazole; D016567:Nizatidine