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

作者：Hasegawa Masahiro^*; Horiki Noriyuki; Tanaka Kyosuke; Wakabayashi Hiroki; Tano Shunsuke; Katsurahara Masaki; Uchida Atsumasa; Takei Yoshiyuki; Sudo Akihiro

来源：Modern Rheumatology, 2013, 23(6): 1172-1178.

DOI：10.1007/s10165-012-0819-2

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

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. %26lt;br%26gt;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. %26lt;br%26gt;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. %26lt;br%26gt;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.

• 出版日期2013-11