Table 2.
Demographic and Baseline Characteristics by WHO Functional Class and Treatment Group (Primary Analysis Set)
| Combination Therapy | Pooled Monotherapy | Ambrisentan Monotherapy | Tadalafil Monotherapy | Total (N = 500) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| (n = 253) | (n = 247) | (n = 126) | (n = 121) | |||||||
| Baseline Functional Class | FC II | FC III | FC II | FC III | FC II | FC III | FC II | FC III | FC II | FC III |
| Patients (n) | 76 | 177 | 79 | 168 | 38 | 88 | 41 | 80 | 155 | 345 |
| Age, years | ||||||||||
| Mean | 50 | 56 | 53 | 55 | 52 | 55 | 54 | 55 | 52 | 56 |
| SD | 16 | 13 | 15 | 15 | 15 | 14 | 15 | 15 | 15 | 14 |
| Female | 66% | 78% | 80% | 82% | 82% | 78% | 78% | 85% | 73% | 80% |
| North Americab | 53% | 43% | 53% | 42% | 53% | 35% | 54% | 49% | 53% | 42% |
| Type of PAH | ||||||||||
| Idiopathic/ Heritable PAH | 53% | 53% | 58% | 59% | 58% | 60% | 59% | 58% | 55% | 56% |
| PAH associated with connective tissue diseasea | 34% | 44% | 28% | 37% | 32% | 36% | 24% | 38% | 31% | 40% |
| PAH associated with congenital heart diseasea | 7% | 0 | 4% | 1% | 3% | 0 | 5% | 1% | 5% | < 1% |
| Hemodynamic variables (mean ± SD) | ||||||||||
| Right atrial pressure (mmHg) |
N = 76 7 ± 4 |
N = 176 8 ± 5 |
N = 79 7 ± 5 |
N = 167 8 ± 5 |
N = 38 7 ± 4 |
N = 87 8 ± 5 |
N = 41 8 ± 5 |
N = 80 9 ± 5 |
N = 155 7 ± 4 |
N = 343 8 ± 5 |
| Pulmonary artery pressure (mmHg) |
N = 76 47 ± 14 |
N = 177 49 ± 12 |
N = 79 46 ± 12 |
N = 168 51 ± 12 |
N = 38 47 ± 13 |
N = 88 52 ± 12 |
N = 41 45 ± 12 |
N = 80 50 ± 13 |
N = 155 46 ± 13 |
N = 345 50 ± 12 |
| Pulmonary capillary wedge pressure (mmHg) |
N = 72 9 ± 3 |
N = 172 8 ± 3 |
N = 77 9 ± 3 |
N = 159 9 ± 3 |
N = 38 8 ± 3 |
N = 83 9 ± 3 |
N = 39 10 ± 3 |
N = 76 9 ± 4 |
N = 149 9 ± 3 |
N = 331 9 ± 3 |
| Cardiac index (L/min/m2) |
N = 73 2.5 ± 0.7 |
N = 176 2.4 ± 0.6 |
N = 79 2.6 ± 0.8 |
N = 164 2.4 ± 0.6 |
N = 38 2.7 ± 0.7 |
N = 87 2.3 ± 0.6 |
N = 41 2.5 ± 0.9 |
N = 77 2.4 ± 0.7 |
N = 152 2.5 ± 0.8 |
N = 340 2.4 ± 0.6 |
| Pulmonary vascular resistance, c (dyne/sec/cm5) |
N = 76 740 ± 370 |
N = 177 860 ± 500 |
N = 79 690 ± 320 |
N = 168 890 ± 420 |
N = 38 690 ± 240 |
N = 88 920 ± 420 |
N = 41 700 ± 350 |
N = 80 850 ± 430 |
N = 155 720 ± 340 |
N = 345 870 ± 460 |
FC Functional class, PAH Pulmonary arterial hypertension, SD Standard deviation, WHO World Health Organization
aPost-hoc summary; bNorth America (vs. Rest of World, mostly Western Europe), cValues have been rounded to two significant digits for ease of comparison