Abstract

Objective: To assess the urate-lowering efficacy and safety of Febuxostat versusAllopurinol in subjects with hyperuricemia and gout. Study design: Randomized controlled trial.Place and duration of study: Department of Orthopaedic and Trauma Surgery Mardan MedicalComplex Teaching Hospital Bacha khan Medical College Mardan from February 2012 to March2013. Material and Methods: Fifty patients of chronic gout and hyperuricemia fulfilling theinclusion criteria were divided into two equal groups by random method having 25 patients eachand received either a fixed dose(80 mg) of Febuxostat (Group A) or Allopurinol (Group B) 300mgonce daily for 16 weeks. The primary end point was the percentage of patients reaching serumurate level <6.0 mg/dl (360 μ mol per liter) at final visit. The secondary end points includereduction in the incidence of gout flares and adverse drug reactions. Results: There were16(64%) males and 9(36%) females with mean age 44.92 years in group A while group B had15(60%) males and 10(40%) females with mean age 46.24 years. At final visit Febuxostat grouphad mean uric acid level of 4.72 mg/dl ±1.56 SD while Allopurinol group had mean serum uricacid level of 6.34 mg/dl ±1.82 SD with majority of patients (84%, n=21) in group A achievingserum uric acid level of < 6 mg/dl (360 μmol/l) while only 60 percent (n=15) of the patients ingroup B had serum urate level of < 6 mg/dl.(P= <0.05). Gout flare was reported in 12 % (n=3) ofgroup A patients and 36% (n=9) in group B patients. Adverse drug reactions were reported in12% (n=3) of group A patients while 24% (n=6) in group B. Conclusions: Febuxostat lowerdserum uric acid levels more potently than Allopurinol while having minimal gout flares and sideeffects.

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