Ra. Blum et al., THE COMPARATIVE EFFECTS OF LANSOPRAZOLE, OMEPRAZOLE, AND RANITIDINE IN SUPPRESSING GASTRIC-ACID SECRETION, Clinical therapeutics, 19(5), 1997, pp. 1013-1023
The effects on 24-hour intragastric pH levels of once-daily doses of l
ansoprazole 15 mg and lansoprazole 30 mg were compared with the effect
s of omeprazole 20 mg QD and ranitidine 150 mg QID in a phase I, rando
mized, double-masked, four-way crossover study conducted in 29 healthy
male volunteers. Subjects received each treatment regimen for 5 conse
cutive days with at least a 2-week washout between treatment periods.
Ambulatory 24-hour intragastric pH values were monitored in each subje
ct at baseline (2 days before crossover period 1) and again before dos
ing on day 5 of each of the four crossover treatment periods. Gastric
pH values increased during all four regimens, with significantly highe
r mean 24-hour pH values noted in subjects receiving lansoprazole 30 m
g QD (4.53 +/- 0.16) compared with those receiving lansoprazole 15 mg
QD (3.97 +/- 0.16), omeprazole 20 mg QD (4.02 +/- 0.16), or ranitidine
150 mg QID (3.59 +/- 0.16). Lansoprazole 30 mg produced significantly
greater mean percentages of time that the gastric pH was above 3.0 an
d 4.0 (75% and 63%, respectively) compared with the other treatment re
gimens. The mean percentages of time during which gastric pH was above
3.0 and 4.0, respectively, for the other treatments were lansoprazole
15 mg, 64% and 48%; omeprazole 20 mg, 63% and 51%; and ranitidine 150
mg, 52% and 38%. All treatment regimens were well tolerated, with no
clinically significant differences between the regimens. Multiple-dose
lansoprazole 30 mg QD produced a significantly increased intragastric
pH level and significantly longer durations of increased intragastric
pH level compared with lansoprazole 15 mg QD, omeprazole 20 mg QD, an
d ranitidine 150 mg QID.