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Febuxostat provides similar protection against major adverse cardiovascular events as allopurinol but is associated with a modest increase in all-cause mortality in gout patients with preexisting cardiovascular disease.
Can febuxostat be prescribed safely to gout sufferers with established cardiovascular (CV) disease? A large real-world target trial emulation offers reassuring evidence on CV outcomes while highlighting a potential concern regarding long-term survival.
Although both febuxostat and allopurinol are recommended as first-line urate-lowering therapies for gout, the CV safety of febuxostat has remained controversial following conflicting findings from the CARES and FAST trials. To address this uncertainty, investigators analyzed long-term electronic health record data from multiple United States centers, focusing specifically on patients with preexisting CV disease.
The study included adults aged ≥50 years with gout who commenced febuxostat or allopurinol. After rigorous propensity score matching for 42 baseline characteristics, 7,555 well-balanced patient pairs were identified. They were followed for up to 10 years, with a median follow-up of 1,558 days. The key outcome was major adverse cardiovascular events (MACE), while all-cause mortality served as the secondary endpoint.
The results delivered a mixed message. Febuxostat did not heighten the risk of MACE compared with allopurinol, with nearly identical outcomes between the two treatment groups (hazard ratio [HR] 1.027). However, those receiving febuxostat experienced a 12.5% higher risk of all-cause mortality (HR 1.125). Importantly, the elevated mortality risk remained consistent across multiple patient subgroups, including White individuals, men, and nonsmokers. Sensitivity analyses further substantiated the stability and robustness of these outcomes.
The study adds valuable real-world evidence to an ongoing clinical debate. While febuxostat appears cardiovascularly comparable to allopurinol with respect to MACE, its association with increased all-cause mortality suggests that clinicians should weigh individual patient characteristics before selecting urate-lowering therapy. For gout sufferers with established CV disease, treatment decisions should extend beyond CV event prevention and also consider long-term survival outcomes.
Clinical Pharmacology & Therapeutics
Cardiovascular Safety of Febuxostat vs. Allopurinol in Gout Patients with Cardiovascular Diseases: A Target Trial Emulation
Xiuwen Wang et al.
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