PMID- 26771445 OWN - NLM STAT- MEDLINE DCOM- 20170123 LR - 20220408 IS - 1502-7732 (Electronic) IS - 0300-9742 (Print) IS - 0300-9742 (Linking) VI - 45 IP - 4 DP - 2016 Jul TI - Safety and efficacy of oral febuxostat for treatment of HLA-B*5801-negative gout: a randomized, open-label, multicentre, allopurinol-controlled study. PG - 304-11 LID - 10.3109/03009742.2015.1099729 [doi] AB - OBJECTIVES: This phase IIIB study compared the efficacy and safety of febuxostat and allopurinol in gout patients with or without tophi who were HLA-B*5801 negative. METHOD: Eligible patients were randomized to a febuxostat group (80 mg QD) or an allopurinol group (300 mg QD). Following an initial 2-week washout period, over the next 12 weeks we made five measurements of serum urate levels along with assessments of adverse events (AEs). RESULTS: Forty-three out of 152 screened subjects (28.3%) were ineligible either because of the presence of the HLA-B*5801 allele or for various other reasons. The febuxostat group (n = 54) and the allopurinol group (n = 55) had no significant differences in demographic or baseline characteristics. From week 2 to week 12, the febuxostat group had a significantly lower serum urate level than the allopurinol group (p