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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
  • Sanuki, Tsuyoshi1
  • Fujita, Tsuyoshi1
  • Kutsumi, Hiromu1
  • Hayakumo, Takanobu1
  • Yoshida, Shun-ichi2
  • Inokuchi, Hideto3
  • Murakami, Manabu1
  • Matsubara, Yoshihiro4
  • Kuwayama, Hajime5, 6
  • Kawai, Takashi7
  • Miyaji, Hideki8
  • Fujisawa, Takashi9
  • Terao, Shuichi10
  • Yamazaki, Yukinao11
  • Azuma, Takeshi1
  • 1 Kobe University Graduate School of Medicine, Department of Gastroenterology, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan , Kobe (Japan)
  • 2 Tabata Gastrointestinal Hospital, 111-1 Morita, Okubo-cho, Akashi, 674-0061, Japan , Akashi (Japan)
  • 3 Hyogo Cancer Center, 13-70 Kitaoji-cho, Akashi, 673-8558, Japan , Akashi (Japan)
  • 4 Translational Research Informatics Center, Department of Data Management and Analyses, 1-5-4 Minatojima-Minamimachi, Chuo-ku, Kobe, 650-0047, Japan , Kobe (Japan)
  • 5 State University of New York, Center for Bioethics and Humanities, 618 Irving Avenue, Room 102, Syracuse, NY, 13210, USA , Syracuse (United States)
  • 6 Dokkyo Medical University Koshigaya Hospital, Department of Gastroenterology, 2-1-50 Minami-Koshigaya, Koshigaya, 343-8555, Japan , Koshigaya (Japan)
  • 7 Tokyo Medical University Hospital, Endoscopy Center, 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan , Tokyo (Japan)
  • 8 Miyaji Medical Clinic, 2-9-3 Kagetsu, Fukui, 910-0022, Japan , Fukui (Japan)
  • 9 Kakogawa West City Hospital, Department of Gastroenterology, 384-1 Hiratsu, Yoneda-cho, Kakogawa, 675-8611, Japan , Kakogawa (Japan)
  • 10 Kakogawa East City Hospital, Department of Gastroenterology, 797-295 Isshiki, Hiraoka-cho, Kakogawa, 675-0115, Japan , Kakogawa (Japan)
  • 11 University of Fukui Hospital, Department of Endoscopic Medicine, 23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, 910-1193, Japan , Fukui (Japan)
Type
Published Article
Journal
Journal of Gastroenterology
Publisher
Springer Japan
Publication Date
Apr 17, 2012
Volume
47
Issue
11
Pages
1186–1197
Identifiers
DOI: 10.1007/s00535-012-0588-x
Source
Springer Nature
Keywords
License
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Abstract

BackgroundPatients 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.MethodsPatients 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.ResultsThe 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).ConclusionsRabeprazole is more effective than gefarnate for reducing the risk of recurrence of peptic ulcer, esophagitis, and gastrointestinal symptoms in LDA users.

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