The efficacy and safety of different doses of febuxostat and allopurinol: A meta-analysis

Abstract

Objectives: This meta-analysis aims to explore the treatment effects and safety of different doses of febuxostat and allopurinol in patients with gout.

Materials and methods: We systematically searched electronic databases and included randomized-controlled trials (RCTs) evaluating the effects of different doses of febuxostat and allopurinol on the number of patients with serum uric acid (SUA) levels ≤6.0 mg/dL, as well as on SUA levels, gout attack incidence and adverse events (AEs) in patients with gout. We calculated pooled effect sizes, including standardized mean differences (SMDs), relative risks (RRs) or risk differences (RDs), using a random-effects model, and estimated the range of effects using 95% confidence intervals (CIs). A total of 16 RCTs involving 19,683 patients were included.

Results: The results showed that compared to allopurinol, febuxostat significantly increased the number of patients with SUA levels ≤6.0 mg/dL, particularly at doses of 40-80 mg/day (RR=1.14, 95% CI: 1.00, 1.30) and >80 mg/day (RR=2.75, 95% CI: 1.68, 4.49). Febuxostat also significantly improved SUA levels (SMD=−0.70, 95% CI: −1.02, −0.37), but had no significant effect on gout attack risk (RR=1.13, 95% CI: 0.94, 1.35). The risk of any-grade AEs was lower in the febuxostat group than in the control group (RR=0.95, 95% CI: 0.93, 0.98), but there were no significant differences in treatment-related AEs (RR=0.99, 95% CI: 0.92, 1.07) and serious AEs (RD=−0.01, 95% CI: −0.02, 0.00).

Conclusion: Overall, compared to allopurinol, febuxostat significantly improves SUA levels in patients with gout and has a certain safety profile. However, more high-quality studies are needed to further explore its efficacy.

Citation: Zhang F, Wang Y. The efficacy and safety of different doses of febuxostat and allopurinol: A meta-analysis. Jt Dis Relat Surg 2025;36(3):562-576. doi: 10.52312/jdrs.2025.1976.