Randomised clinical trial: prevention of recurrence of peptic ulcers by rabeprazole in patients taking low-dose aspirin.

Abstract

BACKGROUND:

Few studies have evaluated the effects of rabeprazole on low-dose aspirin (LDA)-induced gastroduodenal injuries.

AIM:

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.

METHODS:

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.

RESULTS:

Among 472 randomised subjects, 452 subjects (n = 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.

CONCLUSION:

Rabeprazole prevents the recurrence of peptic ulcers with no evidence of a major dose-response effect in subjects on low-dose aspirin therapy.

• Authors: R Iwakiri, K Higuchi, M Kato, M Fujishiro, Y Kinoshita, T Watanabe, T Takeuchi, M Yamauchi, M Sanomura, H Nakagawa, N Sugisaki, Y Okada, H Ogawa, T Arakawa, K Fujimoto
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 40 Issue 7 Pg. 780-95 (Oct 2014) ISSN: 1365-2036 [Electronic] England
• PMID: 25100080 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 John Wiley & Sons Ltd.

Chemical References

• Anti-Ulcer Agents
• Fibrinolytic Agents
• Rabeprazole
• Aspirin

Topics

• Aged
• Anti-Ulcer Agents (therapeutic use)
• Aspirin (administration & dosage, adverse effects)
• Double-Blind Method
• Duodenal Ulcer (chemically induced, drug therapy, prevention & control)
• Female
• Fibrinolytic Agents (administration & dosage, adverse effects)
• Humans
• Male
• Middle Aged
• Rabeprazole (therapeutic use)
• Recurrence
• Secondary Prevention
• Stomach Ulcer (chemically induced, drug therapy, prevention & control)