Introduction: Febuxostat is a potent non-purine selective xanthine oxidase inhibitor approved by the FDA in 2009 for management of hyperuricemia in people with gout. Areas covered: The authors summarize the pre-clinical studies and pivotal randomized controlled trials of febuxostat when used as a treatment for hyperuricaemia in gout Expert opinion: Febuxostat has clinical efficacy in serum urate lowering, and long-term use leads to improved outcomes such as gout flare frequency and tophus burden. Recently published post-approval placebo-controlled trials have demonstrated urate-lowering efficacy and safety of febuxostat in patients with chronic kidney disease, and reduced frequency of gout flares in people with early onset of gout. In November 2017, the FDA issued a drug safety communication based on the preliminary results of the CARES trial. This cardiovascular safety study of 6190 patients with gout and established cardiovascular disease comparing febuxostat and allopurinol showed no difference in the primary endpoint (a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or unstable angina with urgent revascularization), but did report higher all-cause mortality (hazard ratio 1.22) and cardiovascular mortality (hazard ratio 1.34) with febuxostat. Based on currently available data, it seems likely that allopurinol, rather than febuxostat, will remain first line urate-lowering therapy for people with gout.
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