Journal of Gastroenterology

, Volume 47, Issue 11, pp 1186–1197

Rabeprazole reduces the recurrence risk of peptic ulcers associated with low-dose aspirin in patients with cardiovascular or cerebrovascular disease: a prospective randomized active-controlled trial

Authors

  • Tsuyoshi Sanuki
    • Department of GastroenterologyKobe University Graduate School of Medicine
  • Tsuyoshi Fujita
    • Department of GastroenterologyKobe University Graduate School of Medicine
  • Hiromu Kutsumi
    • Department of GastroenterologyKobe University Graduate School of Medicine
  • Takanobu Hayakumo
    • Department of GastroenterologyKobe University Graduate School of Medicine
  • Shun-ichi Yoshida
    • Tabata Gastrointestinal Hospital
  • Hideto Inokuchi
    • Hyogo Cancer Center
  • Manabu Murakami
    • Department of GastroenterologyKobe University Graduate School of Medicine
  • Yoshihiro Matsubara
    • Department of Data Management and AnalysesTranslational Research Informatics Center
  • Hajime Kuwayama
    • Center for Bioethics and HumanitiesState University of New York
    • Department of GastroenterologyDokkyo Medical University Koshigaya Hospital
  • Takashi Kawai
    • Endoscopy CenterTokyo Medical University Hospital
  • Hideki Miyaji
    • Miyaji Medical Clinic
  • Takashi Fujisawa
    • Department of GastroenterologyKakogawa West City Hospital
  • Shuichi Terao
    • Department of GastroenterologyKakogawa East City Hospital
  • Yukinao Yamazaki
    • Department of Endoscopic MedicineUniversity of Fukui Hospital
    • Department of GastroenterologyKobe University Graduate School of Medicine
  • Care Study Group
Original Article—Alimentary Tract

DOI: 10.1007/s00535-012-0588-x

Cite this article as:
Sanuki, T., Fujita, T., Kutsumi, H. et al. J Gastroenterol (2012) 47: 1186. doi:10.1007/s00535-012-0588-x

Abstract

Background

Patients using low-dose aspirin (LDA) have an increased risk of gastroduodenal mucosal lesions and upper gastrointestinal symptoms. We aimed to clarify the efficacy of rabeprazole for preventing peptic ulcer, esophagitis, and gastrointestinal symptoms associated with LDA.

Methods

Patients with a history of peptic ulcers who were receiving LDA for cardiovascular or cerebrovascular disease were randomly assigned to receive rabeprazole at 10 mg daily, rabeprazole at 20 mg daily, or gefarnate (a cytoprotective anti-ulcer agent) at 50 mg twice daily. The primary endpoint was the development of gastric and/or duodenal ulcer at 12 weeks. The modified Lanza score (MLS) and gastrointestinal symptoms were evaluated at baseline and at 12 weeks.

Results

The full analysis set comprised 261 patients (rabeprazole 10 mg: n = 87, rabeprazole 20 mg: n = 89, gefarnate 100 mg: n = 85). The cumulative incidences of gastroduodenal ulcers at 12 weeks in the 10 mg rabeprazole group, 20 mg rabeprazole group, and gefarnate group were 7.4, 3.7, and 26.7 %, respectively (rabeprazole group 5.5 % vs. gefarnate group 26.7 %, hazard ratio [HR] 0.179; 95 % confidence interval [CI] 0.082–0.394; p < 0.0001). The proportions of patients with an MLS of ≥1 and erosive esophagitis were significantly lower in the rabeprazole group than in the gefarnate group at 12 weeks (gastric lesions 33.5 vs. 62.4 %, p < 0.0001; duodenal lesions 5.7 vs. 24.7 %, p < 0.0001; erosive esophagitis 5.8 vs. 19.4 %, p < 0.0001). Rabeprazole was significantly more effective than gefarnate for the resolution and prevention of gastrointestinal symptoms (resolution 53.6 vs. 25.0 %, p = 0.017; occurrence 9.2 vs. 28.3 %, p = 0.0026).

Conclusions

Rabeprazole is more effective than gefarnate for reducing the risk of recurrence of peptic ulcer, esophagitis, and gastrointestinal symptoms in LDA users.

Keywords

Randomized clinical trial Rabeprazole Low-dose aspirin Peptic ulcer

Copyright information

© Springer 2012