Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Febuxostat Versus Allopurinol in the Treatment of Gout in Subjects 65 Years of Age: A Subgroup Analysis of the CONFIRMS Trial.

Krishnan1,  Eswar, MacDonald2,  Patricia A., Hunt2,  Barbara, Jackson2,  Robert

Stanford University, Stanford, CA
Takeda Global Research & Development Center, Inc., Lake Forest, IL

Purpose:

Efficacy and safety of urate-lowering therapy (ULT) in an older gout population has been infrequently reported. Febuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for the treatment of hyperuricemia in patients with chronic gout. This is a subset analysis of 374 elderly subjects (>=65 years of age) from a total of 2269 subjects treated with febuxostat (FEB) or allopurinol (ALLO) for 6 months from the CONFIRMS study.1

Methods:

Subjects with gout and serum urate levels (sUA) >=8.0 mg/dL were randomized to FEB 40 mg, FEB 80 mg, or ALLO (200/300 mg based on renal function) once daily. Gout flare prophylaxis (colchicine or naproxen) was provided for the entire study duration. The outcomes of interest were percent of elderly subjects with sUA <6.0 mg/dL by renal functional status and safety in this at-risk population.

Results:

The 374 subjects were predominately male (86%), Caucasian (85%), and obese (51% with body mass index [BMI]>=30 kg/m2), with a mean age of 71 years. Baseline characteristics and comorbidities were similar across groups; 82% had hypertension, 25% diabetes, 24% coronary artery disease, 21% cardiac arrhythmia, and 11% previous myocardial infarction. The three treatment groups were similar in age, gender, race, and duration of gout. Mean duration of gout was 15 years with a baseline sUA 9.4 mg/dL, with history of tophi (19%) and kidney stones (20%); 98% of subjects had some degree of renal impairment. Urate-lowering therapy use, at some time prior to study entry, was reported by 71% of subjects (ALLO 63% and 15% FEB). The proportions of subjects whose final sUA was <6.0 mg/dL were 62% (71/115), 82% (105/128), and 47% (62/131) in the FEB 40 mg, FEB 80 mg, and ALLO groups, respectively. Results by renal function status are presented in the table. The most frequently reported AEs irrespective of treatment were diarrhea (10%) and upper respiratory infection (8%). The majority were transient and resolved while on treatment. Serious AEs were reported by 8% in the FEB 40 mg, 6% in the FEB 80 mg, and 11% in the ALLO group. The most common serious AEs were cardiac disorders, 1%, 2%, and 3%, and lower respiratory tract infections, 1%, 0%, and 2%, in the FEB 40 mg, FEB 80 mg, and ALLO treatment groups, respectively. There were no hypersensitivity reactions. Overall response rates were similar to those seen in the combined CONFIRMS population.

Percent of Subjects Achieving sUA <6 mg/dLFEB 40 mg n/N (%)FEB 80 mg n/N (%)ALLO 200/300 mg n/N (%)
Normal (CLcr >=90 mL/min)2/3 (67)1/2 (50)1/1 (100)
Mild (CLcr >=60 to 89 mL/min)33/45 (73)39/44 (89)*31/50 (62)
Moderate (CLcr >30 to 59 mL/min)36/67 (54)65/82 (79)*,**30/80 (38)
*p<0.05, FEB 80 mg vs ALLO;**p<0.05, FEB 80 vs FEB 40 mg.

Conclusions:

Treatment with FEB reduced sUA to <6.0 mg/dL in this elderly population with significant cardiovascular comorbidities and was well tolerated. Response in the elderly moderately renally impaired population was statistically significantly better with either dose of FEB vs ALLO.

Reference:

1.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:R63.

To cite this abstract, please use the following information:
Krishnan, Eswar, MacDonald, Patricia A., Hunt, Barbara, Jackson, Robert; Febuxostat Versus Allopurinol in the Treatment of Gout in Subjects 65 Years of Age: A Subgroup Analysis of the CONFIRMS Trial. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :154
DOI: 10.1002/art.27923

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