Randomised clinical trial: prevention of recurrence of peptic ulcers by rabeprazole in patients taking low‐dose aspirin. Issue 7 (6th August 2014)

• Record Type: Journal Article
• Authors: Iwakiri, R.; Higuchi, K.; Kato, M.; Fujishiro, M.; Kinoshita, Y.; Watanabe, T.; Takeuchi, T.; Yamauchi, M.; Sanomura, M.; Nakagawa, H.; Sugisaki, N.; Okada, Y.; Ogawa, H.; Arakawa, T.; Fujimoto, K.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 40:Issue 7(2014)
• Page Start: 780
• Page End: 795
• Publication Date: 2014-08-06
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.12907
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt12907-abs-0001"> <title>Summary</title> <sec id="apt12907-sec-0001" sec-type="section"> <title>Background</title> <p>Few studies have evaluated the effects of rabeprazole on low‐dose aspirin (LDA)‐induced gastroduodenal injuries.</p> </sec> <sec id="apt12907-sec-0002" sec-type="section"> <title>Aim</title> <p>To conduct a randomised, double‐blind, triple‐dummy, active‐controlled, multicentre trial, named the PLANETARIUM study, to assess the efficacy, dose–response relationship and safety of rabeprazole for peptic ulcer recurrence in Japanese patients on long‐term LDA therapy.</p> </sec> <sec id="apt12907-sec-0003" sec-type="section"> <title>Methods</title> <p>Eligible patients had a history of endoscopically confirmed peptic ulcers and were receiving long‐term LDA (81 or 100 mg/day) therapy for cardiovascular or cerebrovascular protection. Subjects were randomly segregated into three groups receiving rabeprazole 10 mg once daily (standard dose in Japan), rabeprazole 5 mg once daily, or teprenone (geranylgeranylacetone; mucosal protective agent commercially available in Japan) 50 mg three times per day as an active control. The primary endpoint was recurrence of peptic ulcers over 24 weeks.</p> </sec> <sec id="apt12907-sec-0004" sec-type="section"> <title>Results</title> <p>Among 472 randomised subjects, 452 subjects (<italic>n</italic> = 151, 150, 151, respectively) constituted the full analysis set. The cumulative recurrence rates of peptic ulcers over 24 weeks in the 10‐ and 5‐mg rabeprazole groups were 1.4% and 2.8%, respectively, both of which were significantly lower than that in the teprenone group (21.7%). The cumulative occurrence rate of bleeding ulcers over 24 weeks in the teprenone group was 4.6%, while bleeding ulcers were not observed in the 10‐ or 5‐mg rabeprazole groups. Rabeprazole was well tolerated at both doses.</p> </sec> <sec id="apt12907-sec-0005" sec-type="section"> <title>Conclusion</title> <p>Rabeprazole prevents the recurrence of peptic ulcers with no evidence of a major dose–response effect in subjects on low‐dose aspirin therapy.</p> </sec> </abstract>