Febuxostat for the treatment of hyperuricemia in patients with gout

Abstract

Febuxostat (Takeda Pharmaceuticals North America, Inc., IL, USA) is a novel, nonpurine selective inhibitor of xanthine oxidase, approved for the treatment of hyperuricemia in patients with gout. There have been four randomized, double-blind controlled trials and two open-label extension studies evaluating the safety and efficacy of febuxostat in lowering serum urate concentration among patients with gout, including those with mild-to-moderate renal insufficiency. These trials compared febuxostat with placebo or allopurinol 200–300 mg daily; although, notably, the maximum US FDA approved dose of allopurinol is up to 800 mg daily for patients with a creatinine clearance >20 ml/min. Febuxostat may be a safe and effective alternative for treating gout patients where allopurinol 300 mg/day is neither safe nor effective. Owing to imbalances in cardiovascular event frequency between allopurinol- and febuxostat-treated patient groups in earlier studies, the manufacturer of febuxostat has initiated a large, FDA-ma...