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The CARES study was presented Monday at the American College of Cardiology meeting in Orlando and finds that while the rates of all major cardiovascular (CV) events were comparable between febuxostat or allopurinol, there were more CV deaths with febuxostat. (Citation source bit.ly/2HtUEaz)
The study (also reported in the New England Journal of Medicine) included 6190 gout patients (with a history of CV disease) who received febuxostat or allopurinol, and followed for a median of 32 months. The primary endpoint was a combination of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or unstable angina with urgent revascularization.
The primary end-point event occurred in 335 patients (10.8%) in the febuxostat group and in 321 patients (10.4%) in the allopurinol group (hazard ratio 1.03); the rate of gout flares was similar between groups.
But all-cause and cardiovascular mortality was higher in the febuxostat group than in the allopurinol group (hazard ratio for death from any cause, 1.22 [95% CI, 1.01 to 1.47]; hazard ratio for cardiovascular death, 1.34 [95% CI, 1.03 to 1.73]). The risk of death from cardiovascular disease was 34 percent higher with febuxostat and all cause deaths were 22 percent higher with febuxostat.
Febuxostat was approved in 2009. At the time, the FDA reviewed old and supplemental evidence regarding the risk of cardiovascular problems.
The trial is hampered by high rate of regimen discontinuations (57%) and those who discontinued follow-up (45%).
Thus in CV high risk gout patients febuxostat did not fare as well as allopurinol.