Cardiovascular Adverse Events (AE)
At least one CV AE was investigator-reported in 5% of all subjects: 5%, 5%, and 6% of subjects in the febuxostat 40 mg, febuxostat 80 mg, and allopurinol groups, respectively. No difference between treatment groups in specific CV AEs was detected. Pre-specified adjudication of all deaths and all AEs reported to be CV system-related identified a total of six subjects experiencing an adjudicated APTC (Antiplatelet Trialists Collaboration) event: zero in the febuxostat 40 mg group, three in the febuxostat 80 mg group and three in the allopurinol group. All subjects experiencing an adjudicated APTC event had prior medical histories of or underlying risk factors for CVD. Differences in the rates of adjudicated non-APTC CV events between treatment groups were not significant.
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