Gout therapies and cardiovascular risk
The US Food and Drug Administration has recently released a safety announcement  reporting an increased risk of heart-related deaths and death from all causes in the treatment arm assigned to febuxostat in the CARES (CArdiovascular safety of febuxostat and allopurinol in patients with gout and cardiovascular comoRbiditiES) trial . This large (over 6,000 patients with prevalent cardiovascular [CV] disease) double-blind randomized trial has been run over a 5-year follow-up period to compare cardiovascular risk in patients with gout treated with febuxostat compared with those randomized to allopurinol as comparator. The primary CV end point for this trial is a composite of CV death, nonfatal myocardial infarction, nonfatal stroke, and unstable angina requiring urgent coronary revascularization. To date, no difference has been shown between randomization arms for the primary composite outcome, but febuxostat showed an increased risk of the secondary outcomes of heart-related death and death from all causes.