Febuxostat Linked to Increased Death Risk in Gout Patients With Heart Disease

Participants were followed for a median of 32 months
Participants were followed for a median of 32 months

HealthDay News — For patients with gout and cardiovascular disease, febuxostat is noninferior to allopurinol for rates of adverse cardiovascular events but is associated with higher all-cause and cardiovascular mortality, according to a study published online March 12 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the American College of Cardiology, held from March 10 to 12 in Orlando, Florida.

William B. White, MD, from the University of Connecticut School of Medicine in Farmington, and colleagues conducted a double-blind noninferiority trial involving 6,190 patients with gout and cardiovascular disease who were randomized to receive febuxostat or allopurinol. Participants were followed for a median of 32 months. 

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In 56.6% of patients the trial regimen was discontinued, and 45.0% discontinued follow-up. In the modified intention-to-treat analysis, the researchers found that a primary end point event (composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or unstable angina with urgent revascularization) occurred in 10.8 and 10.4% of patients in the febuxostat and allopurinol groups, respectively (hazard ratio, 1.03; upper limit of the one-sided 98.5% confidence interval, 1.23; P=0.002 for noninferiority). Compared with the allopurinol group, the febuxostat group had significantly higher all-cause and cardiovascular mortality.

"In patients with gout and major cardiovascular coexisting conditions, febuxostat was noninferior to allopurinol with respect to rates of adverse cardiovascular events," the authors write.

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The study was funded by Takeda, the manufacturer of febuxostat.


White, WB, et al. Primary Results of the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Comorbidities. Abstract 408-8.