Febuxostat Not Associated With Increased Risks for CVD Events, All-Cause Mortality in Gout

CVD, CHD, cardiovascular disease
CVD, CHD, cardiovascular disease
Researchers assessed whether febuxostat increased the risk of developing cardiovascular events, death from cardiac-cause, and all-cause mortalities.

Use of febuxostat is not associated with increased risk for all-cause mortality, death from cardiovascular diseases (CVD), or CVD events, according to study results published in The Journal of Rheumatology.

A safety study previously indicated that febuxostat vs allopurinol use contributed to the risk for cardiovascular mortality. In the current study, researchers collected data on CVD events and mortality (including CVD-related) in patients with hyperuricemia from 20 relevant studies across several databases. They conducted a meta-analysis to validate the safety of febuxostat and its association with CVD, heart-related mortality, and all-cause mortality. Risk ratios (RRs) were calculated or extracted from studies.

Researchers determined that there were no clear associations between febuxostat and increased risk for mortality of any cause (RR=0.87; 95% CI, 0.57-1.32). There was also no significant difference between febuxostat and allopurinol or placebo in terms of incidence of all-cause mortality. Data also revealed that there was no association between febuxostat and CVD death incidences (RR=0.84; 95% CI, 0.49-1.45) and CVD events (RR=0.98; 95% CI, 0.83-1.16; P =.827). Researchers also found that likelihood of CVD event occurrence was not dependent on febuxostat dose (RR=1.04; 95% CI, 0.84-1.30; P=.723)

Overall, results indicated that febuxostat vs allopurinol or placebo was not associated with increased risk for CVD events, CVD-related mortality, or all-cause death.

Study limitations included limited data from published articles in clinical trials, the short-term nature of included studies, and lack of data on other drugs used in combination with febuxostat that could increase risk for CVD-related events.

Study authors concluded, “…patients and doctors should carefully consider the potential CV risks associated with febuxostat use in the treatment of patients with gout and underlying hyperuricemia. In future, more [randomized controlled] trials should be performed to validate findings of this meta-analysis.”


Deng H, Zhang BL, Tong JD, Yang XH, Jin HM. Febuxostat use and risks of CVD events, death from cardiac-cause and all-cause mortality: metaanalysis of randomized controlled trials. Published online August 15, 2020. J Rheumatol. doi:10.3899/jrheum.200307