E-非布司他治疗痛风的疗效和安全性-5年随访研究 FOCUS--2009 +.pdf

Rheumatology 2009;48:188–194 doi:10.1093/rheumatology/ken457 Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study 1 2 3 3 3 H. R. Schumacher Jr , M. A. Becker , E. Lloyd , P. A. MacDonald and C. Lademacher Objectives. This 5-yr study assessed urate-lowering and clinical efficacy and safety of long-term febuxostat therapy in subjects with gout. The primary efficacy end-point was reduction to and maintenance of serum urate (sUA) levels 6.0 mg/dl. Methods. Subjects who completed a previous 28-day study were entered into an open-label extension study and initially received febuxostat 80 mg daily. Between Weeks 4 and 24, dosing could be adjusted to febuxostat 40 or 120 mg. All subjects received gout flare prophylaxis during the first 4 weeks. Gout flares were recorded and treated throughout the study, and sUA, baseline tophi and safety were monitored. Results. Among 116 subjects initially enrolled, dose adjustments were made for 44 (38%) subjects. As a result, 8 subjects received febuxostat 40 mg, 79 received 80 mg, and 29 received 120 mg daily maintenance dose. At 5 yrs, 93% (54/58) of the remaining subjects had sUA 6.0 mg/dl. Fifty-eight subjects (50%) discontinued prematurely; 38 did so in the first year. Thirteen subjects withdrew due to an adverse event. Sustained reduction of sUA was associated with nearly complete elimination of gout flares. In 26 subjects with a tophus at baseline, D o resolution was achieved in 69% (18/26) by last visit on study drug at any point