title: 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.
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.
authors.affiliation: Department of Gastroenterology, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Sanuki
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Fujita
authors.forename: Hiromu
authors.initials: H
authors.lastname: Kutsumi
authors.forename: Takanobu
authors.initials: T
authors.lastname: Hayakumo
authors.forename: Shun-ichi
authors.initials: S
authors.lastname: Yoshida
authors.forename: Hideto
authors.initials: H
authors.lastname: Inokuchi
authors.forename: Manabu
authors.initials: M
authors.lastname: Murakami
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Matsubara
authors.forename: Hajime
authors.initials: H
authors.lastname: Kuwayama
authors.forename: Takashi
authors.initials: T
authors.lastname: Kawai
authors.forename: Hideki
authors.initials: H
authors.lastname: Miyaji
authors.forename: Takashi
authors.initials: T
authors.lastname: Fujisawa
authors.forename: Shuichi
authors.initials: S
authors.lastname: Terao
authors.forename: Yukinao
authors.initials: Y
authors.lastname: Yamazaki
authors.forename: Takeshi
authors.initials: T
authors.lastname: Azuma
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use*; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects* / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000188:drug therapy; D002561:Cerebrovascular Disorders / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004941:Esophagitis / Q000139:chemically induced / Q000517:prevention & control; D005260:Female; D005778:Gefarnate / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010437:Peptic Ulcer / Q000139:chemically induced / Q000517:prevention & control*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D064750:Rabeprazole; D055502:Secondary Prevention
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D010975:Platelet Aggregation Inhibitors; D005778:Gefarnate; D064750:Rabeprazole; D001241:Aspirin