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Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study
Rheumatology, 01/16/09
Schumacher Jr HR et al. - Study reports that the long-term treatment with febuxostat resulted in durable maintenance of serum urate (sUA) <6.0 mg/dl for most gout pts, with nearly complete abolition in pts completing the study. Baseline tophi resolved in a majority of subjects.
Methods- 5-yr study assessed urate-lowering and clinical efficacy and safety of long-term febuxostat therapy in gout pts (n=116)
- Primary efficacy end-point: reduction to and maintenance of sUA levels <6.0 mg/dl
- Subjects received febuxostat 80 mg/d who completed a previous 28-d study
- Between wks 4 and 24, dosing could be adjusted to febuxostat 40 or 120 mg
- All subjects received gout flare prophylaxis during the first 4 wks
- Gout flares, sUA, baseline tophi and safety were monitored throughout
- Dose adjustments were made in 38% of pts
- At 5 yrs, 93% of the remaining subjects had sUA <6.0 mg/dl
- 50% of pts discontinued prematurely; 38 did so in the first year
- 13 subjects withdrew due to an AE
- Sustained reduction of sUA was associated with nearly complete elimination of gout flares
- In 26 subjects with a tophus at baseline, resolution was achieved in 69% by last visit
- No deaths were reported during the study
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