To Study Regulatory Requirements for Marketing authorization of Febuxostat Tablet in India

Febuxostat has been approved for the treatment of h yperuricemia in patients with/without gout. This me taanalysis and systematic review assessed the efficac y and tolerability of febuxostat in hyperuricemia p atients with/without gout. Major electronic databases were searched for articles of all publication years (up to February 2012), as were the Web sites of the American College of Rheumatology, the European League Against Rheumatism, and the Chinese State Food and Drug Administration, and clinical trials. gov for unpublish ed studies. Only randomized, controlled trials (RCTs) were included. Ten trials were included. A signific antly greater proportion of patients achieved the target serum urate level (sUA ≤6.0 mg/dL) at the final visit in the febuxostat group compared with the placebo (OR = 235.73; P < 0.01) and allopurinol groups (OR = 3.14; P < 0.01). In subgroup analysis, the proportion of pati ents who achieved target sUA at the final visit was significantly greater in the febuxostat-treated gro up (40 mg/d) compared with the allopurinol-treated group (100‐300 mg/d) (50.9% vs 45.6%; OR = 1.25; 95% CI, 1.05‐1.49; P = 0.01). As the dosage was increased (40, 80, 120 mg/d), the proportion of patients who achie ved targets UA in the febuxostat-treated group incr eased gradually (50.9%, 71.4%, 82%, respectively). There was no significant difference in the occurrence of adverse events (AEs) between the febuxostat- and allopurino l-treated groups.