Vol.23 No.6

Original Article

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

Authors

Masahiro Hasegawa 1 , Noriyuki Horiki 2 , Kyosuke Tanaka 2 , Hiroki Wakabayashi1 , Shunsuke Tano2 , Masaki Katsurahara 2 , Atsumasa Uchida 1 , Yoshiyuki Takei3 , Akihiro Sudo1

  • Department of Orthopedic Surgery, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu Mie, 514-8507, Japan
  • Department of Endoscopy, Mie University Graduate School of Medicine, Tsu, Japan
  • Department of Gastroenterology and Hepatology, Mie University Graduate School of Medicine, Tsu, Japan
Received:

7 September 2012

Accepted:

10 December 2012

Published online:

10 January 2013

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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 on100 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.

Key words

Gastrointestinal tract, NSAIDs, COX-2 inhibitors, Rheumatoid arthritis, Osteoarthritis