Dr. Chohan has received consulting fees (less than $10,000) from Takeda Global Research & Development Center, Inc.
Women with gout: Efficacy and safety of urate-lowering with febuxostat and allopurinol†
Article first published online: 25 JAN 2012
Copyright © 2012 by the American College of Rheumatology
Arthritis Care & Research
Volume 64, Issue 2, pages 256–261, February 2012
How to Cite
Chohan, S., Becker, M. A., MacDonald, P. A., Chefo, S. and Jackson, R. L. (2012), Women with gout: Efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res, 64: 256–261. doi: 10.1002/acr.20680
ClinicalTrials.gov identifiers: NCT00174915, NCT00102440, and NCT00430248.
- Issue published online: 25 JAN 2012
- Article first published online: 25 JAN 2012
- Accepted manuscript online: 2 NOV 2011 08:55AM EST
- Manuscript Accepted: 19 OCT 2011
- Manuscript Received: 1 JUN 2011
- TAP Pharmaceutical Products (now part of Takeda Global Research & Development Center, Inc.)
To compare the characteristics of female versus male gout patients and assess urate-lowering efficacy and safety of febuxostat or allopurinol treatment in women with gout.
This was a retrospective analysis of 4,101 hyperuricemic (serum urate [sUA] level ≥8.0 mg/dl) gout subjects enrolled in 3 phase III comparative trials and randomized to receive placebo, febuxostat (40 mg, 80 mg, 120 mg, or 240 mg daily), or allopurinol (100 mg, 200 mg, or 300 mg daily, based on renal function). Baseline demographics and characteristics were summarized and compared between female and male subjects. Urate-lowering efficacy, which was defined as the proportion of subjects with sUA levels <6.0 mg/dl at final visit, was assessed for all subjects and, among women, according to baseline renal function.
Female gout subjects (n = 226) were older with significantly higher rates of obesity and metabolic and cardiovascular comorbidities than their male counterparts. The percentage of female subjects with sUA levels <6.0 mg/dl at final visit was 0% in the placebo group, 54.3%, 85.1%, 81.0%, and 100.0% in the febuxostat 40 mg, 80 mg, 120 mg, and 240 mg groups, respectively, and 45.9% in the allopurinol group. Similar patterns of urate-lowering efficacy rates were observed when stratified by renal function. Among all the female subjects, febuxostat 80 mg was significantly more efficacious than allopurinol (P < 0.001). Rates of adverse events (AEs) were low. The most frequently reported AEs were upper respiratory tract infections, musculoskeletal/connective tissue disorders, and diarrhea.
These data suggest that febuxostat 80 mg may be more efficacious than commonly prescribed doses of allopurinol in female gout subjects with high rates of comorbidities.