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An allopurinol-controlled, multicenter, randomized, double-blind, parallel between-group, comparative study of febuxostat in Chinese patients with gout and hyperuricemia.
Int J Rheum Dis. 2014 Jul; 17(6):679-86.IJ

Abstract

AIM

Febuxostat, a novel non-purine selective inhibitor of xanthine oxidase, has been identified as a potential alternative to allopurinol in patients with hyperuricemia. The purpose of this study was to compare the urate-lowering (UL) efficacy and safety of daily febuxostat and allopurinol in Chinese gout patients with hyperuricemia.

METHODS

Gout patients (n = 512) with serum uric acid (sUA) concentrations of at least 8.0 mg/dL were randomized to receive daily febuxostat 40 mg or 80 mg or allopurinol 300 mg for 28 weeks. Prophylaxis against gout flares with meloxicam or colchicine was provided during weeks 1 through 8. The primary endpoint was the percentage of subjects achieving a sUA concentration of <6.0 mg/dL at the last three monthly measurements.

RESULTS

The primary endpoint was reached in 44.77% of patients receiving 80 mg of febuxostat, 27.33% of those receiving 40 mg of febuxostat, and 23.84% of those receiving allopurinol. The UL efficacy in the febuxostat 80 mg group was higher than in the allopurinol (P < 0.0001) and febuxostat 40 mg (P = 0.0008) groups. The UL efficacy of the febuxostat 40 mg group was statistically non-inferior to that of the allopurinol group. No significant change in the number of tophi was observed during the final visit relative to baseline in each treatment group. The rate of gout flares requiring treatment from weeks 9 through 28 and the incidence of adverse events was similar among treatment groups.

CONCLUSIONS

The UL efficacy of daily febuxostat 80 mg was greater than that of febuxostat 40 mg and allopurinol 300 mg, which exhibited comparable UL efficacy. Safety of febuxostat and allopurinol was comparable at the doses tested.

Authors+Show Affiliations

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24467549

Citation

Huang, Xinfang, et al. "An Allopurinol-controlled, Multicenter, Randomized, Double-blind, Parallel Between-group, Comparative Study of Febuxostat in Chinese Patients With Gout and Hyperuricemia." International Journal of Rheumatic Diseases, vol. 17, no. 6, 2014, pp. 679-86.
Huang X, Du H, Gu J, et al. An allopurinol-controlled, multicenter, randomized, double-blind, parallel between-group, comparative study of febuxostat in Chinese patients with gout and hyperuricemia. Int J Rheum Dis. 2014;17(6):679-86.
Huang, X., Du, H., Gu, J., Zhao, D., Jiang, L., Li, X., Zuo, X., Liu, Y., Li, Z., Li, X., Zhu, P., Li, J., Zhang, Z., Huang, A., Zhang, Y., & Bao, C. (2014). An allopurinol-controlled, multicenter, randomized, double-blind, parallel between-group, comparative study of febuxostat in Chinese patients with gout and hyperuricemia. International Journal of Rheumatic Diseases, 17(6), 679-86. https://doi.org/10.1111/1756-185X.12266
Huang X, et al. An Allopurinol-controlled, Multicenter, Randomized, Double-blind, Parallel Between-group, Comparative Study of Febuxostat in Chinese Patients With Gout and Hyperuricemia. Int J Rheum Dis. 2014;17(6):679-86. PubMed PMID: 24467549.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An allopurinol-controlled, multicenter, randomized, double-blind, parallel between-group, comparative study of febuxostat in Chinese patients with gout and hyperuricemia. AU - Huang,Xinfang, AU - Du,Hui, AU - Gu,Jieruo, AU - Zhao,Dongbao, AU - Jiang,Lindi, AU - Li,Xinfu, AU - Zuo,Xiaoxia, AU - Liu,Yi, AU - Li,Zhanguo, AU - Li,Xiangpei, AU - Zhu,Ping, AU - Li,Juan, AU - Zhang,Zhiyi, AU - Huang,Anbin, AU - Zhang,Yuanchao, AU - Bao,Chunde, Y1 - 2014/01/28/ PY - 2014/1/29/entrez PY - 2014/1/29/pubmed PY - 2015/6/30/medline KW - allopurinol KW - febuxostat KW - gout KW - hyperuricemia SP - 679 EP - 86 JF - International journal of rheumatic diseases JO - Int J Rheum Dis VL - 17 IS - 6 N2 - AIM: Febuxostat, a novel non-purine selective inhibitor of xanthine oxidase, has been identified as a potential alternative to allopurinol in patients with hyperuricemia. The purpose of this study was to compare the urate-lowering (UL) efficacy and safety of daily febuxostat and allopurinol in Chinese gout patients with hyperuricemia. METHODS: Gout patients (n = 512) with serum uric acid (sUA) concentrations of at least 8.0 mg/dL were randomized to receive daily febuxostat 40 mg or 80 mg or allopurinol 300 mg for 28 weeks. Prophylaxis against gout flares with meloxicam or colchicine was provided during weeks 1 through 8. The primary endpoint was the percentage of subjects achieving a sUA concentration of <6.0 mg/dL at the last three monthly measurements. RESULTS: The primary endpoint was reached in 44.77% of patients receiving 80 mg of febuxostat, 27.33% of those receiving 40 mg of febuxostat, and 23.84% of those receiving allopurinol. The UL efficacy in the febuxostat 80 mg group was higher than in the allopurinol (P < 0.0001) and febuxostat 40 mg (P = 0.0008) groups. The UL efficacy of the febuxostat 40 mg group was statistically non-inferior to that of the allopurinol group. No significant change in the number of tophi was observed during the final visit relative to baseline in each treatment group. The rate of gout flares requiring treatment from weeks 9 through 28 and the incidence of adverse events was similar among treatment groups. CONCLUSIONS: The UL efficacy of daily febuxostat 80 mg was greater than that of febuxostat 40 mg and allopurinol 300 mg, which exhibited comparable UL efficacy. Safety of febuxostat and allopurinol was comparable at the doses tested. SN - 1756-185X UR - https://www.unboundmedicine.com/medline/citation/24467549/An_allopurinol_controlled_multicenter_randomized_double_blind_parallel_between_group_comparative_study_of_febuxostat_in_Chinese_patients_with_gout_and_hyperuricemia_ L2 - https://doi.org/10.1111/1756-185X.12266 DB - PRIME DP - Unbound Medicine ER -