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Table 1 Demographics, baseline characteristics, and comorbiditiesa

From: The efficacy and safety of febuxostat for urate lowering in gout patients ≥65 years of age

Variable

Febuxostat 40 mg

N = 115

Febuxostat 80 mg

N = 128

Allopurinol 200/300 mg

N = 131

Gender, n (%)

   

Male

104 (90.4)

109 (85.2)

108 (82.4)

Female

11 (9.6)

19 (14.8)

23 (17.6)

Race, n (%)

   

American Indian or Alaska Native

1 (0.9)

1 (0.8)

0

Asian

2 (1.7)

4 (3.1)

5 (3.8)

Black or African American

10 (8.7)

16 (12.5)

8 (6.1)

Native Hawaiian or Other Pacific Islander

1 (0.9)

2 (1.6)

0

White

98 (85.2)

103 (80.5)

116 (88.5)

Other

3 (2.6)

2 (1.6)

2 (1.5)

Ethnicity, n (%)

   

Hispanic or Latino

2 (1.7)

3 (2.3)

9 (6.9)

Not Hispanic or Latino

113 (98.3)

125 (97.7)

122 (93.1)

Age (years)

   

Mean ± SD

70.8 ± 5.19

71.2 ± 5.22

70.1 ± 4.59

Range

65-85

65-85

65-85

Body mass index (kg/m 2 )

   

Mean ± SD

31.0 ± 5.47

30.7 ± 5.13

31.6 ± 5.60

Range

20-48

16-49

22-48

Alcohol use, n (%)

   

Non-/Ex-drinker

42 (36.5)

49 (38.3)

53 (40.5)

Drinker (1-14 drinks/week)

73 (63.5)

79 (61.7)

78 (59.5)

Serum urate (mg/dL)

   

Mean ± SD

9.4 ± 1.14

9.5 ± 1.17

9.3 ± 1.04

Range

8-14

8-13

8-13

Years with gout

   

Mean ± SD

15.0 ± 11.3

14.8 ± 12.40

14.1 ± 12.44

Range

0-53

0-50

0-48

Tophi present, n (%)

   

No

93 (80.9)

104 (81.3)

105 (80.2)

Yes

22 (19.1)

24 (18.8)

26 (19.8)

Participated in a previous febuxostat study b, n (%)

   

Yes

18 (15.7)

23 (18.0)

21 (16.0)

Prior urate lowering therapies, n (%)

   

No

31 (27.0)

34 (26.6)

44 (33.6)

Yes (any)

84 (73.0)

94 (73.4)

87 (66.4)

Febuxostat

17 (14.8)

21 (16.4)

18 (13.7)

Allopurinol

76 (66.1)

85 (66.4)

75 (57.3)

Probenecid

5 (4.3)

6 (4.7)

6 (4.6)

Other

4 (3.5)

4 (3.1)

3 (2.3)

Renal Function c, n (%)

   

Moderately Impaired

67 (58.3)

82 (64.1)

80 (61.1)

Mildly Impaired

45 (39.1)

44 (34.4)

50 (38.2)

Normal

3 (2.6)

2 (1.6)

1 (0.8)

Medical History, n (%)

   

Any cardiovascular diseased

102 (88.7)

108 (84.4)

116 (88.5)

Hypertension

98 (85.2)

102 (79.7)

108 (82.4)

Coronary artery disease

26 (22.6)

28 (21.9)

37 (28.2)

Cardiac arrhythmia

16 (13.9)

28 (21.9)

35 (26.7)

Diabetes

23 (20.0)

35 (27.3)

34 (26.0)

Hypercholesterolemia

15 (13.0)

10 (7.8)

17 (13.0)

Hyperlipidemia

66 (57.4)

73 (57.0)

84 (64.1)

Use of low-dose aspirin (≤325 mg daily)

48 (41.7)

52 (40.6)

49 (37.4)

  1. aThere were no statistically significant differences among treatment groups with respect to the distribution of baseline characteristics.
  2. bSubjects previously enrolled in prior febuxostat clinical trials were permitted to enroll in the CONFIRMS trial.
  3. cModerate baseline renal impairment: estimated creatinine clearance (eCLcr) 30- < 60 mL/min; mild baseline renal impairment: eCLcr 60- < 90 mL/min; normal: eCLcr ≥90 mL/min.
  4. d Any cardiovascular disease includes myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass graft procedure, coronary artery disease, transient ischemic attack, peripheral vascular disease, cardiac arrhythmia, venous thrombotic event, valvular heart disease, congestive heart disease, and hypertension. SD = Standard deviation