Reassessing the cardiovascular safety of febuxostat: implications of the FAST study.

Abstract

The US FDA-mandated CARES trial, published in 2018, reported increased all-cause and cardiovascular (CV) death in participants randomized to febuxostat compared with allopurinol. The subsequent FDA Drug Safety Communication and Boxed Warning resulted in substantial reductions in febuxostat use in the US. The EMA-mandated Febuxostat versus Allopurinol Streamlined Trial (FAST), published in 2020, found no increased risk of composite CV events, CV mortality or all-cause mortality for febuxostat, compared with allopurinol. This commentary discusses implications of these new findings for gout management.