Table 1.
Baseline Characteristics of Randomized Subjectsa
| 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/m2) | |||
| 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 Functionb | |||
| 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) |
aThere are no statistically significant differences among treatment groups with respect to the distribution of baseline characteristics.
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.