TY - JOUR T1 - 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 JF - Annals of the Rheumatic Diseases JO - Ann Rheum Dis SP - 270 LP - 276 DO - 10.1136/annrheumdis-2017-211574 VL - 77 IS - 2 AU - Hisashi Yamanaka AU - Shigenori Tamaki AU - Yumiko Ide AU - Hyeteko Kim AU - Kouichi Inoue AU - Masayuki Sugimoto AU - Yuji Hidaka AU - Atsuo Taniguchi AU - Shin Fujimori AU - Tetsuya Yamamoto Y1 - 2018/02/01 UR - http://ard.bmj.com/content/77/2/270.abstract N2 - 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. ER -