title: The efficacy of rebamipide add-on therapy in arthritic patients with COX-2 selective inhibitor-related gastrointestinal events: a prospective, randomized, open-label blinded-endpoint pilot study by the GLORIA study group.
abstract: OBJECTIVE
  We aimed to confirm the effect of combined treatment with celecoxib and rebamipide would be more effective than celecoxib alone for prevention of upper gastrointestinal (GI) events.
  
  
  METHODS
  Patients with rheumatoid arthritis, osteoarthritis, and low back pain were enrolled in this study. Patients were randomized to two groups: a monotherapy group (100 mg celecoxib twice daily) and a combination therapy group (add on 100 mg of rebamipide three times a day). The GI mucosal injury was evaluated by endoscopic examination before treatment and at 3 months. The primary endpoint was to evaluate the preventive effect of the combination therapy group for GI events, endoscopic upper GI ulcers and intolerable GI symptoms, compared with the monotherapy group.
  
  
  RESULTS
  Seventy-five patients were enrolled. Sixty-five patients were analyzed (16 males, 49 females; mean age: 67 ± 13 years). The prevalence of upper GI events, five of endoscopic GI ulcers and one of intolerable GI symptoms, were 6/34 (17.6%) in the monotherapy group and 0/31 in the combination therapy group, p = 0.0252.
  
  
  CONCLUSIONS
  The combination therapy group was more effective than the monotherapy group for prevention of upper GI events in this study. Rebamipide might be a candidate for an option to prevent COX-2 selective inhibitor-induced upper GI events.
authors.affiliation: Department of Orthopedic Surgery, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan, masahase@clin.medic.mie-u.ac.jp.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Hasegawa
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Horiki
authors.forename: Kyosuke
authors.initials: K
authors.lastname: Tanaka
authors.forename: Hiroki
authors.initials: H
authors.lastname: Wakabayashi
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Tano
authors.forename: Masaki
authors.initials: M
authors.lastname: Katsurahara
authors.forename: Atsumasa
authors.initials: A
authors.lastname: Uchida
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Takei
authors.forename: Akihiro
authors.initials: A
authors.lastname: Sudo
mesh_terms: D000409:Alanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D000068579:Celecoxib; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000517:prevention & control; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D010865:Pilot Projects; D011720:Pyrazoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D015363:Quinolones / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013449:Sulfonamides / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D041742:Upper Gastrointestinal Tract / Q000187:drug effects*
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D004791:Enzyme Inhibitors; D011720:Pyrazoles; D015363:Quinolones; D013449:Sulfonamides; D000068579:Celecoxib; C052785:rebamipide; D000409:Alanine