title: A randomized, double-blind, placebo-controlled study of rebamipide for gastric mucosal injury taking aspirin with or without clopidogrel.
abstract: BACKGROUND
  Antithrombotic drugs, such as low-dose aspirin (LDA) and clopidogrel, can cause upper gastrointestinal complications.
  
  
  OBJECTIVE
  The goal of the present study was to investigate whether a mucosal-protective agent, rebamipide, could prevent gastric mucosal injuries induced by LDA with or without clopidogrel in healthy subjects.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled trial was performed with 32 healthy male volunteers. Subjects were randomly assigned to a 14-day course of one of the following regimens: group A, placebo (tid) + LDA; group B, rebamipide (100 mg tid) + LDA (100 mg once-daily); group C, placebo + LDA + clopidogrel (75 mg once-daily); or group D, rebamipide + LDA + clopidogrel. The grade of gastric mucosal injuries was evaluated by esophagogastroduodenoscopy before and after dosing (on day 0 and day 14), and the grade of gastric mucosal injury was assessed according to the modified Lanza score. Subjective symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS). A rapid urease test was performed on day 0, and blood tests were performed on day 0 and day 14.
  
  
  RESULTS
  Rebamipide significantly inhibited gastric mucosal injury induced by LDA alone or by LDA plus clopidogrel when compared with placebo in healthy subjects. GSRS score and hemoglobin level were not significantly different among the four groups.
  
  
  CONCLUSIONS
  Rebamipide is useful for the primary prevention of gastric mucosal injury induced by LDA alone or by LDA plus clopidogrel in healthy subjects.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Tozawa
authors.forename: Tadayuki
authors.initials: T
authors.lastname: Oshima
authors.forename: Takuya
authors.initials: T
authors.lastname: Okugawa
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Ogawa
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Ohda
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Tomita
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Hida
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Fukui
authors.forename: Kazutoshi
authors.initials: K
authors.lastname: Hori
authors.forename: Jiro
authors.initials: J
authors.lastname: Watari
authors.forename: Shiro
authors.initials: S
authors.lastname: Nakamura
authors.forename: Hiroto
authors.initials: H
authors.lastname: Miwa
mesh_terms: D000328:Adult; D000409:Alanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001241:Aspirin / Q000009:adverse effects*; D000077144:Clopidogrel; D004311:Double-Blind Method; D005753:Gastric Mucosa / Q000293:injuries; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced / Q000517:prevention & control*; D064368:Healthy Volunteers; D006801:Humans; D008297:Male; D010437:Peptic Ulcer / Q000139:chemically induced / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D015363:Quinolones / Q000627:therapeutic use*; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives*; D055815:Young Adult
chemical_list: D000897:Anti-Ulcer Agents; D010975:Platelet Aggregation Inhibitors; D015363:Quinolones; D000077144:Clopidogrel; C052785:rebamipide; D000409:Alanine; D013988:Ticlopidine; D001241:Aspirin