Table 5.
Summary of laboratory data
| Placebo | Dotinurad | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 mg | 2 mg | 4 mg | ||||||||||
| n | Mean ± SD | P value | n | Mean ± SD | P value | n | Mean ± SD | P value | n | Mean ± SD | P value | |
| AST (standard value: 10–40 U/L) | ||||||||||||
| Run-in period | 20 | 25.9 ± 4.4 | – | 20 | 24.7 ± 6.8 | – | 19 | 28.1 ± 6.0 | – | 21 | 31.6 ± 8.0 | – |
| Week 2 | 20 | 24.6 ± 5.5 | 0.299 | 20 | 23.9 ± 7.0 | 0.247 | 19 | 26.9 ± 8.5 | 0.589 | 21 | 32.5 ± 10.2 | 0.591 |
| Week 4 | 19 | 24.0 ± 4.2 | 0.206 | 20 | 24.7 ± 7.6 | 0.942 | 19 | 29.7 ± 19.3 | 0.657 | 21 | 29.4 ± 10.1 | 0.196 |
| Week 6 | 19 | 24.3 ± 4.9 | 0.347 | 19 | 24.9 ± 11.1 | 0.967 | 19 | 26.8 ± 8.6 | 0.416 | 21 | 30.3 ± 10.5 | 0.480 |
| Week 8 | 19 | 24.4 ± 4.9 | 0.262 | 18 | 22.9 ± 5.4 | 0.095 | 18 | 25.6 ± 6.2 | 0.031* | 21 | 31.6 ± 18.6 | 1.000 |
| ALT (standard value: 5–45 U/L) | ||||||||||||
| Run-in period | 20 | 28.2 ± 13.3 | – | 20 | 22.4 ± 10.6 | – | 19 | 26.0 ± 9.1 | – | 21 | 37.1 ± 19.5 | – |
| Week 2 | 20 | 25.4 ± 11.3 | 0.285 | 20 | 22.8 ± 10.9 | 0.658 | 19 | 26.3 ± 10.3 | 0.895 | 21 | 35.4 ± 16.1 | 0.501 |
| Week 4 | 19 | 23.5 ± 10.2 | 0.166 | 20 | 24.3 ± 11.9 | 0.206 | 19 | 28.1 ± 21.3 | 0.664 | 21 | 31.9 ± 16.9 | 0.132 |
| Week 6 | 19 | 24.7 ± 10.1 | 0.284 | 19 | 23.2 ± 13.6 | 0.757 | 19 | 26.1 ± 11.7 | 0.983 | 21 | 32.5 ± 15.8 | 0.083 |
| Week 8 | 19 | 23.9 ± 8.9 | 0.124 | 18 | 20.6 ± 9.3 | 0.179 | 18 | 24.3 ± 7.4 | 0.132 | 21 | 43.5 ± 69.2 | 0.612 |
| γ-GTP (standard value: ≤ 80 U/L) | ||||||||||||
| Run-in period | 20 | 64.2 ± 49.6 | – | 20 | 46.9 ± 39.8 | – | 19 | 84.4 ± 102.3 | – | 21 | 72.9 ± 46.8 | – |
| Week 2 | 20 | 58.1 ± 31.0 | 0.386 | 20 | 46.6 ± 39.4 | 0.872 | 19 | 93.1 ± 136.4 | 0.356 | 21 | 69.2 ± 48.2 | 0.567 |
| Week 4 | 19 | 52.1 ± 27.2 | 0.253 | 20 | 49.0 ± 41.1 | 0.235 | 19 | 95.7 ± 153.7 | 0.428 | 21 | 69.0 ± 46.1 | 0.572 |
| Week 6 | 19 | 49.5 ± 21.5 | 0.185 | 19 | 47.0 ± 43.4 | 0.234 | 19 | 94.3 ± 140.2 | 0.363 | 21 | 68.1 ± 46.9 | 0.511 |
| Week 8 | 19 | 53.6 ± 25.9 | 0.377 | 18 | 40.6 ± 37.0 | 0.594 | 18 | 98.1 ± 148.3 | 0.403 | 21 | 69.0 ± 47.8 | 0.614 |
| Creatinine (standard value: 0.61–1.04 mg/dL) | ||||||||||||
| Run-in period | 20 | 0.814 ± 0.090 | – | 20 | 0.842 ± 0.084 | – | 19 | 0.879 ± 0.096 | – | 21 | 0.859 ± 0.096 | – |
| Week 2 | 20 | 0.831 ± 0.109 | 0.357 | 20 | 0.856 ± 0.092 | 0.247 | 19 | 0.866 ± 0.075 | 0.353 | 21 | 0.899 ± 0.104 | 0.031* |
| Week 4 | 19 | 0.838 ± 0.105 | 0.269 | 20 | 0.845 ± 0.100 | 0.779 | 19 | 0.865 ± 0.089 | 0.468 | 21 | 0.871 ± 0.117 | 0.322 |
| Week 6 | 19 | 0.830 ± 0.108 | 0.387 | 19 | 0.832 ± 0.108 | 0.587 | 19 | 0.864 ± 0.089 | 0.355 | 21 | 0.872 ± 0.109 | 0.373 |
| Week 8 | 19 | 0.833 ± 0.113 | 0.383 | 18 | 0.844 ± 0.077 | 0.963 | 18 | 0.863 ± 0.102 | 0.480 | 21 | 0.888 ± 0.116 | 0.039* |
Paired t test was used to compare with baseline values
*P < 0.05