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.


Urate-Lowering (UL) Efficacy and Safety of Febuxostat (FEB) and Allopurinol (ALLO) in Women with Gout, an Older Subset of Gout Subjects with Increased Comorbidity.

Chohan3,  Saima, Becker3,  Michael A., MacDonald1,  Patricia A., Chefo2,  Solomon, Jackson2,  Robert

Takeda Global R&D Inc, Lake Forest, IL
Takeda Global Research & Development Center, Inc, Deerfield, IL
University of Chicago, Chicago, IL

Background:

Although the incidence and prevalence of gout is increasing in the older population of both genders, literature on women with gout confirms later mean onset of the disease in women than men (averaging a decade or more after menopause) and suggests that the frequent comorbidities (renal impairment, cardiovascular disease, metabolic syndrome components, diuretic use) accompanying hyperuricemia/gout in men may be even more common in women. Given this background, we evaluated the UL efficacy and safety of therapy with FEB or ALLO in the subset of women enrolled in a series of randomized controlled clinical trials (RCTs) comparing these xanthine oxidase inhibitors.

Methods:

4101 subjects (3875 men/226 women) participated in the 12-month FACT or the 6-month APEX or CONFIRMS trials. This post-hoc subset analysis focuses on female subjects with gout and serum urate levels (sUA) >=8.0 mg/dL who were randomized (study specific) to daily PBO (n=11 subjects), FEB (n=139), or ALLO (n=76). Baseline renal functional status was assessed by estimated creatinine clearance (eCLcr) calculated using the Cockcroft-Gault formula. UL efficacy results are reported according to study drug and dose administered and stratified by baseline renal function.

Results:

The 5.5% women subjects in these RCTs had a mean age of 62 y (vs 52 y men), and 74% had BMI >=30 kg/m2 (62% men). Comorbid history (women vs men), was significant for hypertension (81% vs 48%), diabetes (26% vs 10%), hyperlipidemia (46% vs 37%) and renal impairment (64% eCLcr <60 mL/min vs 13%). Gout history: 19% of women and 21% of men had tophi; 86% and 85%, respectively, had experienced a gout flare in the prior year, and mean disease duration was 8 y women and 12 y men. Mean sUA at baseline was 9.7 mg/dL for both men and women. Proportions of women subjects with final visit sUA <6.0 mg/dL are presented by renal functional status in the Table.

Table. Proportions of Women Subjects With Final Visit sUA <6.0 mg/dL

Baseline Renal Function (eCLcr)PBO n/N (%)FEB 40 mg n/N (%)FEB 80 mg n/N (%)FEB 120 mg (n/N (%)FEB 240 mg n/N (%)ALLO 100/200/300 mg* n/N (%)
Normal (>=90 mL/min)0/1 (0)1/2 (50)7/7 (100)1/1 (100)NA1/2 (50)
Mid (>=60–<90 mL/min)0/5 (0)8/10 (80)21/25 (84)4/5 (80)3/3 (100)9/18 (50)
Moderate or severe (17–59 mL/min)0/5 (0)10/23 (44)35/42 (83)12/15 (80)4/4 (100)24/54 (44)
*2 subjects with CLcr <80 mL/min received ALLO 100 mg and 32 received ALLO 200 mg NA=not applicable

The most frequently reported AEs among women were: URI (16%), diarrhea (11%), and musculoskeletal/connective tissue (11%). The majority of AEs were transient and resolved while on treatment. The most common serious AEs were cardiac disorders: FEB (all doses 2%) and ALLO (4%).

Conclusions:

In this female population with gout and significant comorbidities, including renal impairment, UL with FEB 80 mg and FEB 120 mg were both superior to that of ALLO (p<0.05). This is the largest number of female hyperuricemic gout subjects treated in RCTs with either FEB or ALLO. Treatment with febuxostat was effective in reducing sUA to <6.0 mg/dL, independent of renal function, and was well tolerated.

To cite this abstract, please use the following information:
Chohan, Saima, Becker, Michael A., MacDonald, Patricia A., Chefo, Solomon, Jackson, Robert; Urate-Lowering (UL) Efficacy and Safety of Febuxostat (FEB) and Allopurinol (ALLO) in Women with Gout, an Older Subset of Gout Subjects with Increased Comorbidity. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :165
DOI: 10.1002/art.27934

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