Time to maximum effect of lansoprazole on gastric pH in normal male volunteers

BACKGROUND: The time to maximum inhibition of gastric acidity resulting from repeated oral dosing with lansoprazole 30 mg daily for 7 days was studied in nine healthy male volunteers. METHODS: Twenty-four hour intragastric pH monitoring was performed before treatment and on days 1, 3, 5 and 7 of dosing with lansoprazole. Blood samples were taken for the estimation of plasma lansoprazole concentrations. RESULTS: Lansoprazole 30 mg increased mean 24-h intragastric pH to 3.57 on day 1 compared with baseline mean pH of 2.11 (P < 0.05). The mean intragastric pH during the morning period (08.00-13.00 h) was significantly higher on days 3, 5 and 7 than on day 1, but no consistent differences between day 1, 3, 5 and 7 were noted for subsequent periods (13.00-18.00, 18.00-21.00 and 23.00-07.00 h). There were no differences in mean pH between days 3, 5 and 7. Intragastric pH was maintained above pH 3 for 54.7, 60.1, 61.9 and 67.4% of the time on days 1, 3, 5 and 7, respectively. Lansoprazole pharmacokinetic parameters did not change with daily dosing. The area under the lansoprazole plasma concentration-time curve correlated with the intragastric pH (P < 0.005). CONCLUSIONS: Lansoprazole 30 mg raised intragastric pH significantly from baseline on day 1 to a maximum effect as early as 6 h after the first dose. The degree and duration of acid suppression confirm the usefulness of lansoprazole for the treatment of acid-related disorders.