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Open Access Highly Accessed Research article

The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial

Michael A Becker1*, H Ralph Schumacher2, Luis R Espinoza3, Alvin F Wells4, Patricia MacDonald5, Eric Lloyd5 and Christopher Lademacher6

Author affiliations

1 The University of Chicago Pritzker School of Medicine, MC0930, University of Chicago Medical Center, 5841 S. Maryland Avenue, Chicago, IL 60637, USA

2 University of Pennsylvania and VA Medical Center, VA Medical Center, 151K University and Woodland Avenues, Philadelphia, PA 19104, USA

3 Rheumatology, Louisiana State University Health Sciences Center, 2820 Napoleon Avenue, Suite 890, New Orleans, LA 70115, USA

4 Rosalind Franklin University of Medicine & Science, 1457 Indian Grass Lane, Grays Lake, IL 60030, USA

5 Takeda Global Research & Development Center Inc., 675 Field Drive, Lake Forest, IL 60045, USA

6 Astellas Pharma Global Development Inc., 3 Parkway North, Deerfield, IL 60015, USA

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Citation and License

Arthritis Research & Therapy 2010, 12:R63  doi:10.1186/ar2978


See related editorial by Singh, http://arthritis-research.com/content/12/4/136

Published: 6 April 2010

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) ≥ 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