Long-term efficacy and safety of rabeprazole in patients taking low-dose aspirin with a history of peptic ulcers: a phase 2/3, randomized,parallel-group, multicenter,extension clinical trial

A 24-week, double-blind, clinical trial of rabeprazole for the prevention ofrecurrent peptic ulcers caused by low-dose aspirin (LDA) has been reported, buttrials for longer than 24 weeks have not been reported. The aim of this study is toassess the long-term efficacy and safety of rabeprazole for preventing peptic ulcerrecurrence on LDA therapy. Eligible patients had a history of peptic ulcers onlong-term LDA (81 or 100 mg/day) therapy. Patients with no recurrence ofpeptic ulcers at the end of the 24-week double-blind phase with rabeprazole (10- or5-mg once daily) or teprenone (50 mg three times daily) entered the extensionphase. Rabeprazole doses were maintained for a maximum of 76 weeks, including thedouble-blind 24-week period and the extension phase period (long-term rabeprazole 10-and 5-mg groups). Teprenone was randomly switched to rabeprazole 10 or 5 mg fora maximum of 52 weeks in the extension phase (newly-initiated rabeprazole 10- and5-mg groups). The full analysis set consisted of 151 and 150 subjects in thelong-term rabeprazole 10- and 5-mg groups, respectively, and the cumulativerecurrence rates of peptic ulcers were 2.2 and 3.7%, respectively. Recurrentpeptic ulcers were not observed in the newly-initiated rabeprazole 10- and 5-mggroups. No bleeding ulcers were reported. No clinically significant safety findings,including cardiovascular events, emerged. The use of long-term rabeprazole 10- and5-mg once daily prevents the recurrence of peptic ulcers in subjects on low-doseaspirin therapy, and both were well-tolerated.