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Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: A 28-week, phase III, randomized, double-blind, parallel-group trial
Arthritis Care and Research , 11/05/08
Schumacher HR et al. - At all doses studied, febuxostat more effectively lowered and maintained serum urate levels <6.0 mg/dl than did allopurinol (300 or 100 mg) or placebo in subjects with hyperuricemia and gout, including those with mild to moderately impaired renal function.
Methods- Study to compare the urate-lowering efficacy and safety of febuxostat, and allopurinol in hyperuricemia and gout pts with impaired renal function
- Pts (n=1,072) were randomized to receive febuxostat x1/d (80 mg, 120 mg, or 240 mg), allopurinol (300 or 100 mg, based on renal function), or placebo for 28 wks
- More subjects treated with febuxostat attained the primary end point of last 3 monthly serum urate levels <6.0 mg/dl vs allopurinol and placebo
- A higher % of subjects with impaired renal function treated with febuxostat achieved the primary end point
- AEs or serious AEs were similar across groups; diarrhea and dizziness more frequent in febuxostat 240 mg group
- Primary reasons for withdrawal were similar across groups
- Withdrawl because of gout flares was more frequent with febuxostat vs allopurinol
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