The efficacy and tolerability of febuxostat treatment in a cohort of Chinese Han population with history of gout

Abstract

Objective To measure the effect of febuxostat on the serum levels of uric acid (sUA) and the proinflammatory cytokines interleukin (IL)-6, IL-17 and tumour necrosis factor-α (TNF-α) in Chinese Han patients with gout and hyperuricaemia. Methods This randomized, double-blind, placebo-controlled pilot study enrolled patients with gout and hyperuricaemia (sUA ≥ 8 mg/dl). Patients were randomized to receive either febuxostat 80 mg or placebo once daily for 24 weeks. The serum levels of sUA, IL-6, IL-17 and TNF-α were measured at weeks 0 (baseline), 2, 4, 8, 12, 16 and 24. Baseline clinical and demographic characteristics were recorded for all patients. Results A total of 156 patients were randomized: placebo group ( n = 78) and febuxostat group ( n = 78). The febuxostat group showed a significantly greater reduction in sUA compared with the placebo group. Serum uric acid concentration was reduced below 8 mg/dl in 46 of 61 patients (75.4%) by week 24. There were also reductions in the serum levels IL-6, IL-17 and TNF-α in the febuxostat group. In the febuxostat group, 10 of 78 patients (12.82%) discontinued treatment due to adverse drug reactions. Conclusion Febuxostat reduced the levels of sUA, TNF-α, IL-6 and IL-17, but there were some side-effects.