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Febuxostat, a xanthine-oxidase inhibitor, is regarded as a second-line urate-lowering therapy for gout (after allopurinol) due to its higher cost and an excess incidence of adverse cardiovascular (CV) events in early clinical trials. In 2019, the U.S. FDA added a boxed warning to febuxostat's label after a postmarketing study showed febuxostat was noninferior to allopurinol for a composite endpoint of major adverse CV events but was associated with significantly more CV-related and all-cause mortality.
In this industry-funded postmarketing safety study, recommended by European regulators, researchers recruited more than 6000 patients with gout and at least one additional CV risk factor who were taking allopurinol (mean age, 71; 99% white) an…