Chronic gout and hyperuricemia; treatment with febuxostat versus allopurinol

ABSTRACT

To assess the urate-lowering efficacy and safety of Febuxostat versus Allopurinol in subjects with hyperuricemia and gout. Randomized controlled trial. Department of Orthopaedic and Trauma Surgery Mardan Medical Complex Teaching Hospital Bacha khan Medical College Mardan from February 2012 to March 2013. Fifty patients of chronic gout and hyperuricemia fulfilling the inclusion criteria were divided into two equal groups by random method having 25 patients each and received either a fixed dose [80 mg] of Febuxostat [Group A] or Allopurinol [Group B] 300mg once daily for 16 weeks. The primary end point was the percentage of patients reaching serum urate level <6.0 mg/dl [360 micro mol per liter] at final visit. The secondary end points include reduction in the incidence of gout flares and adverse drug reactions. There were 16[64%] males and 9[36%] females with mean age 44.92 years in group A while group B had 15[60%] males and 10[40%] females with mean age 46.24 years. At final visit Febuxostat group had mean uric acid level of 4.72 mg/dl +/- 1.56 SD while Allopurinol group had mean serum uric acid level of 6.34 mg/dl +/- 1.82 SD with majority of patients [84%, n=21] in group A achieving serum uric acid level of < 6 mg/dl [360 micro mol/l] while only 60 percent [n=15] of the patients in group B had serum urate level of < 6 mg/dl.[P= <0.05]. Gout flare was reported in 12% [n=3] of group A patients and 36% [n=9] in group B patients. Adverse drug reactions were reported in 12% [n=3] of group A patients while 24% [n=6] in group B. Febuxostat lowerd serum uric acid levels more potently than Allopurinol while having minimal gout flares and side effects