Clinical efficacy and safety of successful longterm urate lowering with febuxostat or allopurinol in subjects with gout
Becker MA et al. – Data show that durable maintenance of goal range serum urate (SUA) level with either dose of febuxostat or in smaller numbers of subjects with allopurinol resulted in near elimination of gout flares and improved tophus status over time. Methods- Aim was to determine longterm urate-lowering efficacy and clinical benefits and safety of therapy with febuxostat or allopurinol in subjects with gout
- Subjects (n=1086) were assigned to fixed-dose daily urate-lowering treatment (ULT) with febuxostat (80 mg or 120 mg) or allopurinol (300 mg)
- ULT reassignment was permitted during mo 1 to 6 to achieve SUA concns between 3.0 and <6.0 mg/dl
- Flares requiring treatment, tophus size, safety, and SUA levels were monitored during up to 40 mo of ULT maintenance
Results- After 1 mo initial treatment, >80% of subjects receiving either febuxostat dose, but only 46% of subjects receiving allopurinol, achieved SUA <6.0 mg/dl
- After ULT reassignment, >80% of all remaining subjects maintained the primary efficacy endpoint of SUA <6.0 mg/dl at each visit
- More subjects initially randomized to allopurinol required ULT reassignment to achieve SUA <6.0 mg/dl vs subjects receiving febuxostat
- Maintenance of SUA <6.0 mg/dl resulted in progressive reduction to nearly 0 in proportion of subjects requiring gout flare treatment
- Baseline tophus resolution was achieved by 46%, 36%, and 29% of subjects maintained on febuxostat 80 mg, febuxostat 120 mg, and allopurinol, respectively
- Overall adverse event rates adjusted for 10-fold greater febuxostat than allopurinol exposure, did not differ among treatment groups
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