Baseline demographics and clinical characteristics (ITT/safety population)
| Characteristic* | Lesinurad 200 mg+allopurinol (n=46) | Lesinurad 400 mg+allopurinol (n=42) | Lesinurad 600 mg+allopurinol (n=48) | Placebo+allopurinol (n=72) |
|---|---|---|---|---|
| Age, year | 52.9 (10.1) | 50.7 (10.4) | 48.4 (11) | 51.1 (9.2) |
| Men, n (%) | 44 (95.7) | 41 (97.6) | 48 (100) | 71 (98.6) |
| Race, n (%) | ||||
| White | 42 (91.3) | 39 (92.9) | 40 (83.3) | 67 (93.1) |
| Black | 2 (4.3) | 2 (4.8) | 4 (8.3) | 3 (4.2) |
| Asian | 2 (4.3) | 0 | 3 (6.3) | 1 (1.4) |
| Native Hawaiian or Pacific Islander | 0 | 1 (2.4) | 1 (2.1) | 1 (1.4) |
| BMI, kg/m2 | 32.7 (5.5) | 32.3 (5.1) | 33.1 (4.7) | 31.9 (4.8) |
| Years since gout diagnosis | 10.2 (9.3) | 6.7 (6.1) | 8 (6.2) | 7.3 (6.3) |
| Flares in last 12 months | 4.1 (3.8) | 3.5 (2.6) | 4.2 (3.9) | 4.2 (3.7) |
| sUA, mg/dL† | 6.4 (1.3) | 6.9 (1.4) | 7.3 (1.5) | 6.7 (1.3) |
| Baseline CrCl (ideal weight),‡ n (%) | ||||
| ≥90 mL/min | 24 (52.2) | 21 (50) | 29 (60.4) | 33 (45.8) |
| 60–89 mL/min | 19 (41.3) | 19 (45.2) | 17 (35.4) | 37 (51.4) |
| 30–59 mL/min | 3 (6.5) | 2 (4.8) | 2 (4.2) | 2 (2.8) |
| <30 mL/min | 0 | 0 | 0 | 0 |
*Values are mean (SD) unless otherwise specified.
†Last sUA value recorded before the first dose of blinded lesinurad or placebo.
‡Based on Cockcroft–Gault formula using ideal body weight; using actual weight, 79%–95% of patients (across groups) had normal renal function.
BMI, body mass index; CrCl, creatinine clearance; ITT, intention-to-treat; sUA, serum urate.