Table 2.
Effect of baseline characteristics on treatment response represented as the percentage of mITT subjects in each subgroup achieving sUA <6.0 mg/dL at Final Visit
| Variable | Febuxostat 40 mg daily N = 757 |
Febuxostat 80 mg daily N = 756 |
Allopurinol 300/200 mg daily N = 755 |
|---|---|---|---|
| % (n/N) | |||
| Renal Functiona | |||
| Moderately Impaired | 43.1 (56/130) | 71.3 (97/136) | 31.6 (43/136) |
| Mildly Impaired | 52.1 (182/349) | 71.7 (263/367) | 46.3 (169/365) |
| Normal | 37.4 (104/278) | 58.1 (147/253) | 41.7 (106/254) |
| Baseline Serum Urate (mg/dL)a | |||
| <9.0 | 60.1 (170/283) | 80.4 (225/280) | 52.7 (144/273) |
| 9.0 to <10.0 | 47.1 (106/225) | 70.7 (157/222) | 40.5 (102/252) |
| ≥10.0 | 26.5 (66/249) | 49.2 (125/254) | 31.3 (72/230) |
| Baseline Tophusa | |||
| No | 48.1 (284/591) | 69.8 (414/593) | 44.6 (271/607) |
| Yes | 34.9 (58/166) | 57.1 (93/163) | 31.8 (47/148) |
| Completed Prior Febuxostat Studya | |||
| No | 43.4 (286/659) | 65.7 (439/668) | 40.8 (271/665) |
| Yes | 57.1 (56/98) | 77.3 (68/88) | 52.2 (47/90) |
aVariable had a significant (P < 0.001) overall effect on attainment of the primary endpoint. After adjusting for the variable, febuxostat 80 mg remained statistically significant compared to both febuxostat 40 mg and allopurinol.