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Febuxostat CARES CV Safety — ESENeph MCQ

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ModerateChronic Kidney DiseaseFebuxostat CARES CV SafetyESENeph

A 45-year-old man with CKD G3b and gout is started on Febuxostat after Allopurinol intolerance. His cardiologist expresses concern about cardiovascular safety. What trial raised CV concerns with Febuxostat?

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Correct answer: A — The CARES trial showed Febuxostat was associated with higher cardiovascular and all-cause mortality compared to Allopurinol in patients with established cardiovascular disease – though the trial had significant limitations including high dropout

The CARES trial (2018, NEJM) compared Febuxostat with Allopurinol in gout patients with established cardiovascular disease. Febuxostat was non-inferior for major cardiovascular events but was associated with significantly higher all-cause and cardiovascular mortality. However, the trial had major limitations: 57% dropout rate and post-hoc analysis suggesting the mortality difference may be related to Allopurinol withdrawal rather than Febuxostat toxicity. The FAST trial (2020) in Europe did NOT confirm the CARES mortality signal. NICE and BSR consider Febuxostat appropriate when Allopurinol is contraindicated/not tolerated, with caution in established CVD.

Reference: CARES Trial – NEJM 2018; FAST Trial – Lancet 2020; NICE CG169