Time-varying cardiovascular risk of febuxostat versus allopurinol in gout: a one-stage meta-analysis

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ID: 326273
2026
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Abstract
OBJECTIVES: Whether febuxostat is associated with an increased cardiovascular risk compared to allopurinol in patients with gout remains controversial, with major randomized trials reporting conflicting results. This study aims to perform a comprehensive meta-analysis using reconstructed individual participant data (IPD) to evaluate the time-varying cardiovascular and mortality risk of febuxostat versus allopurinol in gout. METHODS: We conducted a one-stage individual participant data meta-analysis. PubMed, Embase, and Cochrane Library were searched up to November 2025 for randomized controlled trials and propensity score-matched observational studies reporting Kaplan-Meier curves for cardiovascular risk or all-cause mortality. Individual patient data were reconstructed from published curves. Time-varying hazard ratios (HRs) were estimated using a mixed-effects Cox model with treatment-by-time interaction across pre-specified intervals (0-12, 12-24, 24-48, >48 months). RESULTS: Four studies (n = 19,090) were included. Analysis revealed significant time-varying effects. For cardiovascular risk, HRs were 0.89 (95% CI 0.79 to 0.99) at 0-12 months, 0.58 (0.50 to 0.68) at 12-24 months, 0.86 (0.74 to 0.99) at 24-48 months, and 1.09 (0.81 to 1.46) after >48 months. For all-cause mortality, HRs were 0.70 (0.62 to 0.79), 0.39 (0.33 to 0.45), 0.75 (0.65 to 0.86), and 1.02 (0.77 to 1.34) across the same intervals, respectively. CONCLUSION: The cardiovascular and mortality risk of febuxostat relative to allopurinol is time-dependent, showing a significant early reduction that attenuates over time. These findings advocate for a time-aware approach to clinical management and monitoring.
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openalex_W7203970507 Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Qige Wei, Yang Shi, Rui Hu, Hui Wang, Yan Li, Li Luo, Dan Shao, Jianglin Zhao, Shengzhao Zhang
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Journal Lara D. Veeken
Year 2026
DOI
10.1093/rheumatology/keag457
URL
https://doi.org/10.1093/rheumatology/keag457
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