Safety and efficacy of oral febuxostat for treatment of HLA-B*5801-negative gout: a randomized, open-label, multicentre, allopurinol-controlled study

Scandinavian Journal of Rheumatology
K-H YuH-Y Lin

Abstract

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. 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). 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 ≤ 0.001 for all comparisons) and significantly more patients with serum urate levels less than 6.0 mg/dL. The serum urate levels of the febuxostat group declined by more than 40% from week 2 to week 12 and this decrease was greater than that in the allopurinol group (~30%). The two groups were similar in terms of AEs. Febuxostat was more effective than allopurinol in reducing the serum urate levels of Han Chinese...Continue Reading

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Citations

Jul 12, 2017·Expert Opinion on Pharmacotherapy·Tristan Pascart, Pascal Richette
Apr 12, 2018·Pharmacogenetics and Genomics·Heng ChengYouming Zhang
Jan 3, 2019·Current Opinion in Rheumatology·Thomas Bardin, Pascal Richette
Feb 26, 2019·Drugs·Sohita Dhillon
Mar 17, 2018·Rheumatology·Tristan Pascart, Frédéric Lioté
Mar 14, 2019·International Journal of Rheumatology·John A CuencaLeonardo Tamariz
Apr 18, 2020·Journal of Medical Economics·Sil-Ling PruisMohamed Ismail Abdul Aziz
May 26, 2018·Pharmaceuticals·Andreas Jordan, Ursula Gresser
Mar 28, 2019·Expert Opinion on Drug Safety·Larysa StrilchukArrigo Fg Cicero
Jul 17, 2019·The Journal of Rheumatology·Tenneille Tana, Peter Vadas
Dec 22, 2021·International Journal of Rheumatic Diseases·Jose Paulo P LorenzoWorawit Louthrenoo

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