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FAST Trial Febuxostat — SCE Rheumatology MCQ

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HardCrystal ArthropathyFAST Trial FebuxostatSCE Rheumatology

A 71-year-old man with gout and stable ischaemic heart disease asks about the cardiovascular safety evidence for febuxostat. Which statement most accurately describes the design and principal findings of the FAST trial?

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Correct answer: D — In the primary on-treatment analysis, febuxostat was non-inferior to allopurinol for the composite cardiovascular endpoint, with no associated increase in cardiovascular or all-cause mortality.

FAST was a European prospective, randomised, open-label, blinded-endpoint non-inferiority trial in patients aged at least 60 years who were already receiving allopurinol and had an additional cardiovascular risk factor. In the prespecified primary on-treatment analysis, febuxostat was non-inferior to dose-optimised allopurinol for the composite cardiovascular endpoint (adjusted HR 0.85, 95% CI 0.70–1.03; non-inferiority margin 1.3), without increased cardiovascular or all-cause mortality. Option C describes the contrasting mortality signal from CARES, not FAST. FAST did not establish superiority, so C is incorrect, and the confidence interval remained within the non-inferiority margin, excluding D. The result was not restricted to participants without previous cardiovascular disease, excluding E. Current UK prescribing information nevertheless advises caution and monitoring in patients with major pre-existing cardiovascular disease.

Reference: Mackenzie IS et al. Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST). Lancet. 2020;396:1745–1757. https://pubmed.ncbi.nlm.nih.gov/33181081/