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Table 1 Baseline Characteristics of Randomized Subjectsa

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

Variable

Febuxostat 40 mg daily

N = 757

Febuxostat 80 mg daily

N = 756

Allopurinol 200/300 mg daily

N = 756

  

n (%)

 

Gender

   

   Male

722 (95.4)

710 (93.9)

709 (93.8)

   Female

35 (4.6)

46 (6.1)

47 (6.2)

Race

   

   American Indian or Alaska Native

6 (0.8)

10 (1.3)

6 (0.8)

   Asian

26 (3.4)

25 (3.3)

37 (4.9)

   Black or African American

83 (11.0)

78 (10.3)

67 (8.9)

   Native Hawaiian or Other Pacific

   

   Islander

11 (1.5)

10 (1.3)

11 (1.5)

   White

620 (81.9)

618 (81.7)

625 (82.7)

   Other

11 (1.5)

15 (2.0)

8 (1.1)

   Missing

0

0

2 (0.3)

Ethnicity

   

   Hispanic or Latino

47 (6.2)

49 (6.5)

53 (7.0)

   Not Hispanic or Latino

710 (93.8)

707 (93.5)

702 (92.9)

   Missing

0

0

1 (0.1)

Age (years)

   

   Mean ± SD

52.5 ± 11.68

53.0 ± 11.79

52.9 ± 11.73

   Range

21 to 85

21 to 85

19 to 85

Body Mass Index (kg/m 2 )

   

   Mean ± SD

32.9 ± 6.37

32.9 ± 6.39

32.7 ± 6.23

   Range

20 to 64

16 to 64

17 to 61

Alcohol Use

   

   Non-/Ex-drinker

242 (32.0)

243 (32.1)

235 (31.1)

   Drinker (1 to 14 drinks/week)

515 (68.0)

513 (67.9)

521 (68.9)

Serum Urate (mg/dL)

   

   <9.0

283 (37.4)

280 (37.0)

274 (36.2)

   9 to <10.0

225 (29.7)

222 (29.4)

252 (33.3)

   10.0 to <11.0

162 (21.4)

159 (21.0)

133 (17.6)

   11.0 to <12.0

58 (7.7)

67 (8.9)

64 (8.5)

   ≥12.0

29 (3.8)

28 (3.7)

33 (4.4)

   Mean ± SD

9.6 ± 1.15

9.6 ± 1.20

9.5 ± 1.19

   Range

8 to 14

8 to 15

8 to 15

Years with Gout

   

   Mean ± SD

12.0 ± 9.13

11.7 ± 9.64

11.2 ± 9.14

   Range

0 to 53

0 to 51

0 to 48

Completed Previous Febuxostat Study

98 (12.9)

88 (11.6)

90 (11.9)

Renal Function b

   

   Moderately Impaired

130 (17.2)

136 (18.0)

136 (18.0)

   Mildly Impaired

349 (46.1)

367 (48.5)

365 (48.3)

   Normal

278 (36.7)

253 (33.5)

255 (33.7)

Medical History

   

   Cardiovascular Disease (including hypertension)

421 (55.6)

440 (58.2)

436 (57.7)

   Diabetes

89 (11.8)

113 (14.9)

110 (14.6)

   Hypercholesterolemia

52 (6.9)

53 (7.0)

57 (7.5)

   Hyperlipidemia

299 (39.5)

308 (40.7)

335 (44.3)

   Use of Low-dose Aspirin (≤ 325 mg daily)

133 (17.6)

133 (17.6)

139 (18.4)

  1. aThere are no statistically significant differences among treatment groups with respect to the distribution of baseline characteristics.
  2. bModerate baseline renal impairment: estimated creatinine clearance (eCrCl) 30 to 59 ml/minute; mild baseline renal impairment: eCrCl 60 to 89 ml/minute; normal: eCrCl ≥ 90 ml/minute.