Table 2.
Primary and secondary outcomes of single dose fasudil administration versus placebo in SSc patients with Raynaud’s phenomenon.
| Placebo | Fasudil 40 mg | Fasudil 80 mg | p-value | |
|---|---|---|---|---|
| Recovery Time to 50% pre-CC Temperature* (min) | 7.9 ± 3.1 | 7.5 ± 3.2 | 8.2 ± 3.0 | 0.791 |
| Recovery Time to 70% pre-CC Temperature* (min) | 18.2 ± 10.7 | 15.0 ± 9.4 | 17.1 ± 10.8 | 0.654 |
| Minutes in the cold chamber | 6.94 ± 3.2 | 8.41 ± 4.7 | 7.06 ± 4.0 | 0.496 |
| Rate of skin cooling during CC (°C/min) | 2.74 ± 1.0 | 2.75 ± 1.6 | 3.09 ± 1.3 | 0.674 |
| Digital skin blood flow (PU)† | ||||
| Pre-CC | 122.6 ± 57.6 | 134.1 ± 73.4 | 138.3 ± 55.1 | 0.751 |
| End-CC | 78.6 ± 46.5 | 94.5 ± 64.0 | 110.5 ± 60.6 | 0.28 |
| 5 min | 97.8 ± 56.0 | 112.3 ± 67.9 | 118.6 ± 64.8 | 0.712 |
| 10 min | 101.6 ± 60.7 | 116.0 ± 79.2 | 120.3 ± 70.1 | 0.722 |
| 15 min | 107.4 ± 65.0 | 128.0 ± 84.4 | 126.7 ± 76.8 | 0.676 |
| 20 min | 113.8 ± 69.0 | 134.0 ± 91.9 | 136.5 ± 82.2 | 0.676 |
| 25 min | 123.7 ± 72.5 | 146.9 ± 94.1 | 144.4 ± 91.7 | 0.694 |
| 30 min | 138.7 ± 74.0 | 153.0 ± 96.2 | 143.0 ± 96.8 | 0.894 |
| 35 min | 143.3 ± 84.2 | 152.6 ± 86.9 | 154.0 ± 86.8 | 0.924 |
| 40 min | 147.6 ± 80.7 | 158.9 ± 95.7 | 158.9 ± 93.3 | 0.914 |
| 45 min | 151.7 ± 89.5 | 161.1 ± 100.2 | 170.6 ± 93.5 | 0.849 |
| 50 min | 163.8 ± 93.9 | 166.2 ± 104.3 | 172.4 ± 92.5 | 0.966 |
| 55 min | 155.8 ± 92.1 | 168.7 ± 103.2 | 179.5 ± 88.2 | 0.767 |
| 60 min | 161.3 ± 95.7 | 171.8 ± 97.4 | 177.9 ± 86.2 | 0.875 |
| 4 hrs (after drug administration) | 133.7 ± 63.5 | 156.1 ± 97.1 | 145.1 ± 43.6 | 0.708 |
Recovery times are defined as follows: 0.5 or 0.7 * [(pre-cold challenge digital skin temperature – end-cold challenge digital skin temperature) + end-cold challenge digital skin temperature]
Digital blood flow was measured on the dorsum of the 2nd, 3rd, 4th finger distally to the metacarpal-phalangeal joint. The mean skin surface area analyzed was 68.24 ± 12.88 cm2 CC = cold-challenge; pre-CC = skin temperature measured right before the beginning of the CC; end-CC = skin temperature measured at the end of the CC (CC stopped when digital skin temperature reached 12 °C or the patient could no longer tolerate the cold); PU = perfusion units calculated by the instrument accounting for erythrocyte density and velocity in the sampled volume.