학술논문
Stepwise dose increase of febuxostat is comparable with colchicine prophylaxis for the prevention of gout flares during the initial phase of urate-lowering therapy: results from FORTUNE-1, a prospective, multicentre randomised study
Document Type
Academic Journal
Author
Yamanaka, Hisashi; Tamaki, Shigenori; Ide, Yumiko; Kim, Hyeteko; Inoue, Kouichi; Sugimoto, Masayuki; Hidaka, Yuji; Taniguchi, Atsuo; Fujimori, Shin; Yamamoto, Tetsuya; Yamanaka, Hisashi; Tamaki, Shigenori; Ide, Yumiko; Kim, Hyeteko; Inoue, Kouichi; Sugimoto, Masayuki; Hidaka, Yuji; Akimoto, Mitsuko; Ichikawa, Naomi; Sagawa, Akira; Hirota, Hisayoshi; Tanaka, Tsuneo; Jin, Hiroaki; Koni, Ichiro; Momoi, Yasuharu; Inoue, Soitiro; Izumiyama, Tomomasa; Yagi, Hideyuki; Tsutani, Hiroshi; Hakoda, Masayuki; Ishii, Tomonori; Nakashima, Hiroshi; Hirai, Aizan
Source
Annals of the Rheumatic Diseases. Feb 01, 2018 77(2):270-276
Subject
Language
English
ISSN
0003-4967
Abstract
OBJECTIVES: To determine whether febuxostat with stepwise dose increase is as useful as colchicine prophylaxis in reducing gout flares during the initial introduction of urate-lowering therapy in patients with gout in comparison with febuxostat with no dose titration. METHODS: In this prospective, multicentre, randomised open-label comparative study, patients were randomised to group A (stepwise dose increase of febuxostat from 10 to 40 mg/day), group B (fixed-dose febuxostat 40 mg/day plus colchicine 0.5 mg/day) or group C (fixed-dose febuxostat 40 mg/day) and observed for 12 weeks. Gout flare was defined as non-steroidal anti-inflammatory drug use for gout symptoms. RESULTS: A total of 255 patients were randomised, and 241 patients were treated. Among the treated patients, gout flares were experienced by 20/96 (20.8%) in group A, 18/95 (18.9%) in group B and 18/50 (36.0%) in group C. The incidence of flare was significantly lower in groups A and B than that in group C (P=0.047 and P=0.024, respectively), although the differences were not significant after correction for multiple comparisons. No significant difference was noted between the incidence of gout flare in groups A and B. CONCLUSIONS: Our data suggested that stepwise dose increase of febuxostat and low-dose colchicine prophylaxis effectively reduced gout flares in comparison with fixed-dose febuxostat alone. Stepwise dose increase of febuxostat may be an effective alternative to low-dose colchicine prophylaxis during the introduction of urate-lowering therapy. TRIAL REGISTRATION NUMBER: UMIN 000008414.