Initial potency of lansoprazole and omeprazole tablets on pentagastrin-stimulated gastric acid secretion - a placebo-controlled study in healthy volunteers
P. Muller et al., Initial potency of lansoprazole and omeprazole tablets on pentagastrin-stimulated gastric acid secretion - a placebo-controlled study in healthy volunteers, ALIM PHARM, 14(9), 2000, pp. 1225-1229
Background: The new tablet formulation of omeprazole (Losec MUPS), is thoug
ht to have a stronger acid inhibition than the previously marketed capsules
.
Methods: The effects of the proton pump inhibitors lansoprazole and omepraz
ole tablets on pentagastrin-stimulated acid secretion were compared in Heli
cobacter pylori-negative healthy male volunteers (n = 12). The study was pl
acebo-controlled, crossover matched and double-blind for lansoprazole (Agop
ton) and placebo, and single-blind for omeprazole tablets. Gastric acid res
ponse to sub-maximal pentagastrin-stimulation (0.6 mu g . h/kg b.w.) was de
termined from 12.5 to 14.5 h after the first and second dose of the test dr
ugs.
Results: Lansoprazole 15 mg and 30 mg as well as omeprazole 20 mg tablets c
aused a marked decrease in gastric acid secretion, showing equipotency for
15 mg lansoprazole and 20 mg omeprazole tablets. Their efficacy, however, w
as lower than 30 mg lansoprazole. In addition, the inter-individual variati
on after omeprazole tablets was higher than following lansoprazole, Neither
7.5 mg lansoprazole nor 10 mg omeprazole tablets were clearly different fr
om placebo on the first 2 days. The drugs were well-tolerated. No clinicall
y relevant influence was found on either laboratory screen or cardiovascula
r parameters,
Conclusion: Lansoprazole 15-30 mg shows a stronger acid inhibition and a lo
wer inter-individual variability than the new omeprazole 20 mg tablets on d
ays 1 and 2 of dosing.