Table 1.
Clinical Features of Patients at the Time of Enrollment
| Variable | Riociguat | Placebo |
|---|---|---|
| Female to male ratio | 6:2 | 8:0 |
| Race or ethnicity | ||
| Black | 7 | 6 |
| White | 0 | 2 |
| Hispanic | 1 | 0 |
| Age, y | 52 ± 7.0 | 64 ± 6.3a |
| Most recent RHC findings at time of study entry | ||
| PA, mm Hg | ||
| Systolic | 51 ± 4.8 | 49 ± 7.6 |
| Diastolic | 24 ± 4.2 | 19 ± 4.5 |
| Mean | 35 ± 5.1 | 31 ± 5.3 |
| Wedge | 12 ± 4.1 | 10 ± 3.6 |
| Pulmonary vascular resistance, Woods units | 4.4 ± 1.19 | 5.1 ± 2.10 |
| Pulmonary function at enrollment | ||
| FVC, L | 1.98 ± 0.522 | 1.86 ± 0.422 |
| FVC % predicted | 63.8 ± 13.94 | 72.8 ± 13.80 |
| FEV1, L | 1.30 ± 0.491 | 1.23 ± 0.212 |
| FEV1 to FVC ratio, % | 65.7 ± 15.30 | 68.8 ± 16.02 |
| Dlco, mL/min/mm Hg | 10.5 ± 2.73 | 9.1 ± 3.91 |
| Dlco % predicted | 40.6 ± 14.07 | 35.9 ± 9.63 |
| 6MWD, m | 271 ± 95.8 | 332 ± 66.7 |
| Chest radiograph Scadding stage25 | ||
| 1 | 0 | 0 |
| 2 | 1 | 2 |
| 3 | 0 | 1 |
| 4 | 7 | 5 |
| No. of patients receiving individual concurrent antiinflammatory therapy | ||
| Prednisone | ||
| No. | 7 | 5 |
| Daily dose, mg | 10 (5-10) | 10 (5-30) |
| Methotrexate | 2 | 1 |
| Azathioprine | 2 | 0 |
| Mycophenolate mofetil | 1 | 0 |
| Leflunomide | 1 | 0 |
| Hydroxychloroquine | 1 | 2 |
| No therapy | 0 | 1 |
Data are presented as No., median (range), or mean ± SD. 6MWD = 6-min walk distance; Dlco = diffusing capacity for carbon monoxide; PA = pulmonary artery.
a
Significantly higher than riociguat, P < .02.