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

• Published in: Annals of the rheumatic diseases Vol. 77; no. 2; pp. 270 - 276
• Main Authors: Yamanaka, Hisashi, Tamaki, Shigenori, Ide, Yumiko, Kim, Hyeteko, Inoue, Kouichi, Sugimoto, Masayuki, Hidaka, Yuji, Taniguchi, Atsuo, Fujimori, Shin, Yamamoto, Tetsuya
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.02.2018; BMJ Publishing Group
• Series: Extended report
• Subjects: Adult; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Arthritis; Clinical and Epidemiological Research; Clinical trials; Colchicine; Colchicine - adverse effects; Colchicine - therapeutic use; Dose-Response Relationship, Drug; Drug dosages; Febuxostat - administration & dosage; Febuxostat - adverse effects; Gout; Gout - complications; Gout - drug therapy; Gout Suppressants - administration & dosage; Gout Suppressants - adverse effects; Humans; Incidence; Inflammation; Male; Middle Aged; Patients; Prophylaxis; Prospective Studies; Rheumatism; Rheumatology; Symptom Flare Up; Titration; Uric acid; Uric Acid - blood; Japan; arthritis; treatment; gout
• ISSN: 0003-4967; 1468-2060
• DOI: 10.1136/annrheumdis-2017-211574

ObjectivesTo 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.MethodsIn 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.ResultsA 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.ConclusionsOur 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 numberUMIN 000008414.