What is the efficacy and safety of febuxostat in lowering hyperuricemia in women?

Updated: Jan 26, 2021
  • Author: Bruce M Rothschild, MD; Chief Editor: Herbert S Diamond, MD  more...
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The efficacy and safety of febuxostat in women was demonstrated in the CONFIRMS trial and in 2 other trials comparing febuxostat and allopurinol: FACT (Febuxostat Versus Allopurinol Controlled Trial) and APEX (Allopurinol- and Placebo-Controlled, Efficacy Study of Febuxostat). Achievement of a uric acid level below 6.0 mg/dL rose with increasing daily doses of febuxostat doses, from 54.3% in patients receiving 40 mg to 100% in those receiving 240 mg, compared with 45.9% with allopurinol. Results were similar in subjects with renal impairment. [172]

Stepwise introduction of febuxostat—10 mg/day for 4 weeks, then 20 mg/day for 4 weeks, then 40 mg/day—was found to reduce gout flares, in randomized open-label comparative study by Yamanaka et al. [173] Although flares still occurred, their frequency was reduced even in absence of colchicine coverage, so this approach may also be of benefit for individuals with significant contraindications to colchicine or NSAIDs.

White et al reported that all-cause mortality and cardiovascular mortality were higher with febuxostat than with allopurinol (hazard ratio [HR] for death from any cause, 1.22; HR for cardiovascular death, 1.34). [174] In February 2019 the US Food and Drug Administration (FDA) added a black box warning regarding increased risk of death with febuxostat compared with allopurinol. The FDA also limited the approval of febuxostat to use in cases of allopurinol therapeutic failure or intolerance. [175]

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