Febuxostat is used for long-term management of hyperuricemia in patients with gout. The drug is not recommended for the management of asymptomatic hyperuricemia.
The major goal in the management of hyperuricemia and gout is long-term reduction in serum urate concentrations to levels below the limit of urate solubility (about 6.8 mg/dL). Such a reduction over time will prevent or reverse the formation and deposition of urate crystals.
Efficacy of febuxostat was evaluated in 3 randomized, active-controlled studies in patients with hyperuricemia (serum urate concentrations of at least 8 mg/dL) and gout. Because initiation of therapy with urate-lowering agents is associated with an increased frequency of acute gouty attacks (gout flare), patients received concomitant therapy with naproxen or colchicine as prophylaxis against gout flares. At the final evaluation (6 months for 2 studies, 12 months for 1 study), 45%, 67-74%, or 36-42% of those receiving febuxostat 40 mg daily, febuxostat 80 mg daily, or allopurinol (300 mg daily in those with normal renal function; reduced dosage in those with renal impairment), respectively, achieved serum urate concentrations of less than 6 mg/dL.