Table 3.

Implications for clinical practice of the new CARES trial results and FDA public alert on febuxostat safety

Informative discussions with patients on febuxostat CV mortality risk, when initiating and maintaining the drug, are an important part of shared decision making The CARES CV mortality signal does not support first line use of febuxostat in ULT CARES raises new questions on where febuxostat should be placed at different branches in the oral pharmacologic ULT decision tree, when compared to alternatives that work in many gout patients, as supported by: Evidence for efficacy of allopurinol dose-escalation in the majority of patients with gout Evidence for efficacy of uricosuric monotherapy, and of combinations of allopurinol with certain uricosurics Specific recommendations in the 2012 ACR, 2016 EULAR, and 2017 BSR gout management guidelines ULT treatment algorithms in gout now need re-consideration by relevant professional organizations, using appropriate committee processes and methodologies

Abbreviations: ACR (American College of Rheumatology); EULAR (European League Against Rheumatism); BSR (British Society of Rheumatology)