Table 2.
Primary and secondary efficacy endpoints
| End point | Category | Placebo (n = 19) | Dotinurad | ||
|---|---|---|---|---|---|
| 1 mg (n = 20) | 2 mg (n = 19) | 4 mg (n = 21) | |||
| Percent change in serum uric acid level from the baseline to the final visit | Mean ± SD | 0.85 ± 14.53 | 37.03 ± 8.92 | 50.91 ± 10.61 | 64.37 ± 7.67 |
| 95% Confidence Interval | − 6.15 to 7.86 | 32.85 to 41.21 | 45.80 to 56.03 | 60.88 to 67.86 | |
| Jonckheere–Terpstra test | P < 0.001* | ||||
| Tukey–Kramer test | – | P < 0.001* | P < 0.001* | P < 0.001* | |
| Percentage of patients with a serum uric acid level ≤ 6.0 mg/dL at the final visit | Number (%) | 0 (0.0) | 15 (75.0) | 17 (89.5) | 20 (95.2) |
| 95% Confidence Interval | 0.0 to 17.6 | 50.9 to 91.3 | 66.9 to 98.7 | 76.2 to 99.9 | |
| Cochran–Armitage test | P < 0.001* | ||||
| χ2 test | – | P < 0.001* | P < 0.001* | P < 0.001* | |
Jonckheere–Terpstra test and Cochran–Armitage test were used to evaluate dose dependency in the groups of 1 mg, 2 mg, and 4 mg, and placebo
Tukey–Kramer test and χ2 test were adjusted about placebo vs. each dotinurad group
*P < 0.05