An allopurinol controlled, multicenter, randomized, open label, parallel between group, comparative study of febuxostat (TMX 67) a non purine selective inhibitor of xanthine oxidase, in patients with hyperuricemia including those with gout in Japan: phase 2 exploratory clinical study.
BACKGROUND Allopurinol has been widely used for the treatment of hyperuricemia, however, it may be associated with various adverse effects. Febuxostat has been identified as a potentially safe and efficacious alternative. OBJECTIVES Febuxostat was administered to patients with hyperuricemia including gout in Japan to compare its efficacy and safety with those of allopurinol. METHODS The starting dose of febuxostat and allopurinol was 10 and 100 mg/d, respectively, and was increased to the fixed maintenance dose of 40 or 60 mg/d for febuxostat and 300 mg/d for allopurinol for 16 weeks. RESULTS The percent change in the serum uric acid level at 16 weeks compared with the baseline serum uric acid level was 42.96% 13.33% and 52.47% 9.79% for the febuxostat 40 and 60 mg/d groups, respectively, and 36.55% 18.59% for the allopurinol group, indicating that the hypouricemic effects of febuxostat increased in a dose dependent manner and equaled to or surpassed those of allopurinol (P 0.0239, 2 sample t test) The percentage of patients with serum uric acid levels of 6.0 mg/dL or less at 16 weeks was 88.9% and 100% for the febuxostat 40 and 60 mg/d groups, respectively, and 68.8% for the allopurinol group, showing higher achievements for the febuxostat groups compared with the allopurinol group. All adverse drug reactions were mild to moderate in severity, and there were no severe symptoms or reactions leading to drug discontinuation. CONCLUSIONS These results suggest that febuxostat is safe at doses of 40 and 60 mg/d and has equal or greater efficacy than 300 mg/d allopurinol.
Journal of clinical rheumatology practical reports on rheumatic musculoskeletal diseases