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

About author
Rajesh Saini*, Dr. Birendra shrivastav, Ramesh Chand Sharma, Dr. Rajendra Songra
Department of pharmaceutical sciences, Jaipur National University, SADTM Campus, Jaipur-302025. India.
E-mail: [email protected]

Abstract
Febuxostat has been approved for the treatment of hyperuricemia in patients with/without gout. This meta-analysis and systematic review assessed the efficacy and tolerability of febuxostat in hyperuricemia patients 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 gov for unpublished studies. Only randomized, controlled trials (RCTs) were included. Ten trials were included. A significantly 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 patients who achieved target sUA at the final visit was significantly greater in the febuxostat-treated group (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 achieved target sUA in the febuxostat-treated group increased gradually (50.9%, 71.4%, 82%, respectively). There was no significant difference in the occurrence of adverse events (AEs) between the febuxostat- and allopurinol-treated groups.
Key words: Febuxostat, hyperuricemia, gout, meta-analysis