@article {Yamanakaannrheumdis-2017-211574, author = {Hisashi Yamanaka and Shigenori Tamaki and Yumiko Ide and Hyeteko Kim and Kouichi Inoue and Masayuki Sugimoto and Yuji Hidaka and Atsuo Taniguchi and Shin Fujimori and Tetsuya Yamamoto}, editor = {Yamanaka, Hisashi and Tamaki, Shigenori and Ide, Yumiko and Kim, Hyeteko and Inoue, Kouichi and Sugimoto, Masayuki and Hidaka, Yuji and Akimoto, Mitsuko and Ichikawa, Naomi and Sagawa, Akira and Hirota, Hisayoshi and Tanaka, Tsuneo and Jin, Hiroaki and Koni, Ichiro and Momoi, Yasuharu and Inoue, Soitiro and Izumiyama, Tomomasa and Yagi, Hideyuki and Tsutani, Hiroshi and Hakoda, Masayuki and Ishii, Tomonori and Nakashima, Hiroshi and Hirai, Aizan}, title = {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}, elocation-id = {annrheumdis-2017-211574}, year = {2017}, doi = {10.1136/annrheumdis-2017-211574}, publisher = {BMJ Publishing Group Ltd}, 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.}, issn = {0003-4967}, URL = {https://ard.bmj.com/content/early/2017/11/08/annrheumdis-2017-211574}, eprint = {https://ard.bmj.com/content/early/2017/11/08/annrheumdis-2017-211574.full.pdf}, journal = {Annals of the Rheumatic Diseases} }