Baseline characteristics and demographics by treatment group and urinary uric acid status.
| Underexcretors | Overproducers | |||||||
|---|---|---|---|---|---|---|---|---|
| Febuxostat | Febuxostat | |||||||
| Variable | 40 mg, N = 29 | 80 mg, N = 29 | 120 mg, N = 30 | Placebo, N = 30 | 40 mg, N = 8 | 80 mg, N = 9 | 120 mg, N = 7 | Placebo, N = 8 |
| Male, n (%) | 25 (86) | 27 (93) | 25 (83) | 24 (80) | 8 (100) | 9 (100) | 7 (100) | 8 (100) |
| Age, yrs, mean ± SD | 54 ± 13.3 | 57 ± 11.7 | 56 ± 11.0 | 53 ± 11.5 | 46 ± 15.9 | 45 ± 11.4 | 56 ± 11.8 | 50 ± 17.0 |
| Body mass index (kg/m2), n | 29 | 29 | 29 | 30 | 8 | 9 | 7 | 8 |
| Mean ± SD | 32 ± 4.7 | 33 ± 6.5 | 30 ± 5.0 | 32 ± 5.0 | 30 ± 3.7 | 35 ± 7.3 | 36 ± 8.0 | 31 ± 4.4 |
| Tophi present, n (%) | 5 (17) | 7 (24) | 10 (33) | 9 (30) | 1 (13) | 1 (11) | 0 | 0 |
| Nephrolithiasis present, n (%) | 2 (7) | 4 (14) | 1 (3) | 3 (10) | 0 | 3 (33) | 0 | 0 |
| Serum urate (mg/dl), n | 27 | 27 | 28 | 28 | 7 | 8 | 6 | 7 |
| Mean ± SD | 9.3 ± 0.95 | 10.0 ± 1.31 | 9.5 ± 1.09 | 9.9 ± 1.42 | 8.9 ± 0.88 | 9.8 ± 1.49 | 10.1 ± 1.13 | 9.7 ± 0.94 |
| Urine uric acid (mg/day), n | 26 | 27 | 28 | 27 | 7 | 8 | 6 | 7 |
| Mean ± SD | 494 ± 162.5 | 523 ± 155.1 | 473 ± 180.3 | 507 ± 139.0 | 982 ± 178.0 | 1065 ± 336.9 | 1006 ± 206.5 | 934 ± 135.5 |
| Creatinine clearance (ml/min), n | 29 | 28 | 29 | 29 | 8 | 9 | 6 | 8 |
| Mean ± SD | 70 ± 15.4 | 72 ± 18.6 | 64 ± 18.1 | 69 ± 21.5 | 99 ± 31.3 | 112 ± 37.7 | 108 ± 39.4 | 97 ± 8.8 |
| Comorbidities, n (%) | ||||||||
| Cardiovascular disease | 6 (21) | 6 (21) | 6 (20) | 9 (30) | 1 (13) | 0 | 3 (43) | 2 (25) |
| Congestive heart failure | 0 | 4 (14) | 0 | 0 | 0 | 0 | 0 | 1 (13) |
| Diabetes | 5 (17) | 7 (24) | 3 (10) | 2 (7) | 1 (13) | 1 (11) | 1 (14) | 0 |
| Hypercholesterolemia | 4 (14) | 6 (21) | 5 (17) | 2 (7) | 2 (25) | 1 (11) | 2 (29) | 1 (13) |
| Hyperlipidemia | 12 (41) | 15 (52) | 13 (43) | 13 (43) | 4 (50) | 3 (33) | 5 (71) | 4 (50) |
| Hypertension | 13 (45) | 16 (55) | 16 (53) | 17 (57) | 2 (25) | 2 (22) | 3 (43) | 3 (38) |
| Obesity | 4 (14) | 12 (41) | 6 (20) | 8 (27) | 1 (13) | 4 (44) | 4 (57) | 2 (25) |