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

• Published in: Journal of Clinical Biochemistry and Nutrition 2015, Vol.56(3), pp.228-239
• Main Authors: Fujishiro, Mitsuhiro, Higuchi, Kazuhide, Kato, Mototsugu, Kinoshita, Yoshikazu, Iwakiri, Ryuichi, Watanabe, Toshio, Takeuchi, Toshihisa, Sugisaki, Nobuyuki, Okada, Yasushi, Ogawa, Hisao, Arakawa, Tetsuo, Fujimoto, Kazuma, Group, the PLANETARIUM Study
• Format: Article
• Language: English
• Subjects: bleeding ulcer; low-dose aspirin; Original; peptic ulcer; rabeprazole; serious adverse events
• ISSN: 0912-0009; 1880-5086
• DOI: 10.3164/jcbn.15-1

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