V. Savarino et al., Comparison of 24-h control of gastric acidity by three different dosages of pantoprazole in patients with duodenal ulcer, ALIM PHARM, 12(12), 1998, pp. 1241-1247
Background: It is now clear that the extent to which gastric acid secretion
must be suppressed varies with the clinical condition being treated.
Aim: To assess the 24-h control of gastric acidity and the individual respo
nse variability of three different doses of pantoprazole.
Methods: Sixty-four duodenal ulcer patients were recruited for this prospec
tive, randomized, multicentre, double-blind, parallel-group study. They wer
e subdivided into three well-matched groups treated with 20 mg o.m., 40 mg
o.m, and 40 mg b.d. of pantoprazole, respectively. Endoscopy and intragastr
ic pH monitoring were performed in each patient before and after 14 days of
treatment.
Results: Fifty-five patients were eligible for final analysis (17 treated w
ith 20 mg o.m., 18 with 40 mg o.m. and 20 with 40 mg b.d, pantoprazole). Th
e ulcer crater healed in 94, 88 and 95% of cases, respectively. The three d
osages of pantoprazole produced significant increases in gastric pH compare
d to basal levels (P < 0.0001). There was also a clear dose-dependent pharm
acodynamic effect, which augmented on moving from the lowest dosage of 20 m
g o.m. pantoprazole to the highest dosage of 40 mg b.d. (P < 0.01-0.001). T
he inter-individual response variability within the three treatment groups
was more marked with the dose of 20 mg than with the two higher doses of pa
ntoprazole.
Conclusions: All three doses of pantoprazole we tested are highly effective
in decreasing gastric acidity and there is a clear dose-dependent pharmaco
dynamic effect on moving from the lowest to the highest dosage. The greates
t inter individual variation in the degree of acid inhibition was seen with
pantoprazole 20 mg o.m., while the majority of patients responded adequate
ly to the two higher doses of the drug.