Safety and efficacy of oral febuxostat for treatment of HLA-B*5801-negative gout: a randomized, open-label, multicentre, allopurinol-controlled study.
Scand J Rheumatol. 2016 Jul; 45(4):304-11.SJ

Abstract

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 ≤ 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.

CONCLUSIONS

Febuxostat was more effective than allopurinol in reducing the serum urate levels of Han Chinese patients with gout or tophaceous gout who were HLA-B*5801 negative, without causing any serious skin reactions. Febuxostat should be considered for treatment of Han Chinese patients with gout who are HLA-B*5801 negative.

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Authors+Show Affiliations

Yu KH

a Division of Rheumatology, Allergy and Immunology, Department of Internal Medicine , Chang Gung Memorial Hospital and Chang Gung University , Taoyuan , Taiwan , ROC.

Lai JH

b Division of Rheumatology, Allergy and Immunology, Department of Internal Medicine , Chang Gung Memorial Hospital, Chang Gung University and School of Medicine, National Defense Medical Center , Taipei , Taiwan , ROC.

Hsu PN

c Department of Internal Medicine , National Taiwan University Hospital , Taipei , Taiwan , ROC.

Chen DY

d Faculty of Medicine , National Yang-Ming University , Taipei , Taiwan , ROC. e Department of Medical Education and Research , Taichung Veterans General Hospital , Taichung , Taiwan , ROC. f Institute of Biomedical Science , National Chung-Hsing University , Taichung , Taiwan , ROC. g Institute of Microbiology and Immunology , Chung Shan Medical University , Taichung , Taiwan , ROC.

Chen CJ

h Department of Internal Medicine , Kaohsiung Medical University Hospital , Kaohsiung , Taiwan , ROC.

Lin HY

i Division of Allergy, Immunology and Rheumatology , Taipei Veterans General Hospital and National Yang-Ming University School of Medicine , Taipei , Taiwan , ROC. j Taipei Medical University , School of Medicine , Taipei , Taiwan , ROC.

MeSH

Administration, OralAdultAllelesAllopurinolChinaFebuxostatFemaleGoutGout SuppressantsHLA-B AntigensHumansHyperuricemiaMaleMiddle AgedTreatment OutcomeUric Acid

Pub Type(s)

Clinical Trial, Phase III

Journal Article

Multicenter Study

Randomized Controlled Trial

Language

eng

PubMed ID

26771445

Citation

Yu, K-H, et al. "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, vol. 45, no. 4, 2016, pp. 304-11.

Yu KH, Lai JH, Hsu PN, et al. Safety and efficacy of oral febuxostat for treatment of HLA-B*5801-negative gout: a randomized, open-label, multicentre, allopurinol-controlled study. Scand J Rheumatol. 2016;45(4):304-11.

Yu, K. H., Lai, J. H., Hsu, P. N., Chen, D. Y., Chen, C. J., & Lin, H. Y. (2016). 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, 45(4), 304-11. https://doi.org/10.3109/03009742.2015.1099729

Yu KH, et al. Safety and Efficacy of Oral Febuxostat for Treatment of HLA-B*5801-negative Gout: a Randomized, Open-label, Multicentre, Allopurinol-controlled Study. Scand J Rheumatol. 2016;45(4):304-11. PubMed PMID: 26771445.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Safety and efficacy of oral febuxostat for treatment of HLA-B*5801-negative gout: a randomized, open-label, multicentre, allopurinol-controlled study. AU - Yu,K-H, AU - Lai,J-H, AU - Hsu,P-N, AU - Chen,D-Y, AU - Chen,C-J, AU - Lin,H-Y, Y1 - 2016/01/15/ PY - 2016/1/16/entrez PY - 2016/1/16/pubmed PY - 2017/1/24/medline SP - 304 EP - 11 JF - Scandinavian journal of rheumatology JO - Scand J Rheumatol VL - 45 IS - 4 N2 - 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 ≤ 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. CONCLUSIONS: Febuxostat was more effective than allopurinol in reducing the serum urate levels of Han Chinese patients with gout or tophaceous gout who were HLA-B*5801 negative, without causing any serious skin reactions. Febuxostat should be considered for treatment of Han Chinese patients with gout who are HLA-B*5801 negative. SN - 1502-7732 UR - https://www.unboundmedicine.com/medline/citation/26771445/Safety_and_efficacy_of_oral_febuxostat_for_treatment_of_HLA_B_5801_negative_gout:_a_randomized_open_label_multicentre_allopurinol_controlled_study_ DB - PRIME DP - Unbound Medicine ER -

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Safety and efficacy of oral febuxostat for treatment of HLA-B*5801-negative gout: a randomized, open-label, multicentre, allopurinol-controlled study.Scand J Rheumatol. 2016 Jul; 45(4):304-11.SJ