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The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial.
Arthritis Res Ther. 2010; 12(2):R63.AR

Abstract

INTRODUCTION

The purpose of this study was to compare urate-lowering (UL) efficacy and safety of daily febuxostat and allopurinol in subjects with gout and serum urate (sUA) > or = 8.0 mg/dL in a six-month trial.

METHODS

Subjects (n = 2,269) were randomized to febuxostat 40 mg or 80 mg, or allopurinol 300 mg (200 mg in moderate renal impairment). Endpoints included the proportion of all subjects with sUA <6.0 mg/dL and the proportion of subjects with mild/moderate renal impairment and sUA <6.0 mg/dL. Safety assessments included blinded adjudication of each cardiovascular (CV) adverse event (AE) and death.

RESULTS

Comorbidities included: renal impairment (65%); obesity (64%); hyperlipidemia (42%); and hypertension (53%). In febuxostat 40 mg, febuxostat 80 mg, and allopurinol groups, primary endpoint was achieved in 45%, 67%, and 42%, respectively. Febuxostat 40 mg UL was statistically non-inferior to allopurinol, but febuxostat 80 mg was superior to both (P < 0.001). Achievement of target sUA in subjects with renal impairment was also superior with febuxostat 80 mg (72%; P < 0.001) compared with febuxostat 40 mg (50%) or allopurinol (42%), but febuxostat 40 mg showed greater efficacy than allopurinol (P = 0.021). Rates of AEs did not differ across treatment groups. Adjudicated (APTC) CV event rates were 0.0% for febuxostat 40 mg and 0.4% for both febuxostat 80 mg and allopurinol. One death occurred in each febuxostat group and three in the allopurinol group.

CONCLUSIONS

Urate-lowering efficacy of febuxostat 80 mg exceeded that of febuxostat 40 mg and allopurinol (300/200 mg), which were comparable. In subjects with mild/moderate renal impairment, both febuxostat doses were more efficacious than allopurinol and equally safe. At the doses tested, safety of febuxostat and allopurinol was comparable.

CLINICAL TRIAL REGISTRATION

NCT00430248.

Authors+Show Affiliations

The University of Chicago Pritzker School of Medicine, MC0930, University of Chicago Medical Center, 5841 S, Maryland Avenue, Chicago, IL 60637, USA. mbecker@medicine.bsd.uchicago.eduNo 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

20370912

Citation

Becker, Michael A., et al. "The Urate-lowering Efficacy and Safety of Febuxostat in the Treatment of the Hyperuricemia of Gout: the CONFIRMS Trial." Arthritis Research & Therapy, vol. 12, no. 2, 2010, pp. R63.
Becker MA, Schumacher HR, Espinoza LR, et al. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther. 2010;12(2):R63.
Becker, M. A., Schumacher, H. R., Espinoza, L. R., Wells, A. F., MacDonald, P., Lloyd, E., & Lademacher, C. (2010). The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Research & Therapy, 12(2), R63. https://doi.org/10.1186/ar2978
Becker MA, et al. The Urate-lowering Efficacy and Safety of Febuxostat in the Treatment of the Hyperuricemia of Gout: the CONFIRMS Trial. Arthritis Res Ther. 2010;12(2):R63. PubMed PMID: 20370912.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. AU - Becker,Michael A, AU - Schumacher,H Ralph, AU - Espinoza,Luis R, AU - Wells,Alvin F, AU - MacDonald,Patricia, AU - Lloyd,Eric, AU - Lademacher,Christopher, Y1 - 2010/04/06/ PY - 2009/10/29/received PY - 2010/02/02/revised PY - 2010/04/06/accepted PY - 2010/4/8/entrez PY - 2010/4/8/pubmed PY - 2010/9/24/medline SP - R63 EP - R63 JF - Arthritis research & therapy JO - Arthritis Res Ther VL - 12 IS - 2 N2 - INTRODUCTION: The purpose of this study was to compare urate-lowering (UL) efficacy and safety of daily febuxostat and allopurinol in subjects with gout and serum urate (sUA) > or = 8.0 mg/dL in a six-month trial. METHODS: Subjects (n = 2,269) were randomized to febuxostat 40 mg or 80 mg, or allopurinol 300 mg (200 mg in moderate renal impairment). Endpoints included the proportion of all subjects with sUA <6.0 mg/dL and the proportion of subjects with mild/moderate renal impairment and sUA <6.0 mg/dL. Safety assessments included blinded adjudication of each cardiovascular (CV) adverse event (AE) and death. RESULTS: Comorbidities included: renal impairment (65%); obesity (64%); hyperlipidemia (42%); and hypertension (53%). In febuxostat 40 mg, febuxostat 80 mg, and allopurinol groups, primary endpoint was achieved in 45%, 67%, and 42%, respectively. Febuxostat 40 mg UL was statistically non-inferior to allopurinol, but febuxostat 80 mg was superior to both (P < 0.001). Achievement of target sUA in subjects with renal impairment was also superior with febuxostat 80 mg (72%; P < 0.001) compared with febuxostat 40 mg (50%) or allopurinol (42%), but febuxostat 40 mg showed greater efficacy than allopurinol (P = 0.021). Rates of AEs did not differ across treatment groups. Adjudicated (APTC) CV event rates were 0.0% for febuxostat 40 mg and 0.4% for both febuxostat 80 mg and allopurinol. One death occurred in each febuxostat group and three in the allopurinol group. CONCLUSIONS: Urate-lowering efficacy of febuxostat 80 mg exceeded that of febuxostat 40 mg and allopurinol (300/200 mg), which were comparable. In subjects with mild/moderate renal impairment, both febuxostat doses were more efficacious than allopurinol and equally safe. At the doses tested, safety of febuxostat and allopurinol was comparable. CLINICAL TRIAL REGISTRATION: NCT00430248. SN - 1478-6362 UR - https://www.unboundmedicine.com/medline/citation/20370912/The_urate_lowering_efficacy_and_safety_of_febuxostat_in_the_treatment_of_the_hyperuricemia_of_gout:_the_CONFIRMS_trial_ L2 - https://arthritis-research.biomedcentral.com/articles/10.1186/ar2978 DB - PRIME DP - Unbound Medicine ER -