Table 1.
Baseline Characteristics*
| Characteristic | Oral Treprostinil (n = 346) | Placebo (n = 344) | Overall (n = 690) |
|---|---|---|---|
| Age, yr | 45.6 ± 15.7 | 44.8 ± 15.4 | 45.2 ± 15.5 |
| Sex, F, n (%) | 275 (79.5) | 269 (78.2) | 544 (78.8) |
| Race, n (%) | |||
| White | 187 (54.0) | 173 (50.3) | 360 (52.2) |
| Black or African American | 8 (2.3) | 13 (3.8) | 21 (3.0) |
| Asian | 150 (43.4) | 156 (45.3) | 306 (44.3) |
| Unknown | 1 (0.3) | 2 (0.6) | 3 (0.4) |
| Region, n (%) | |||
| North America | 39 (11.3) | 54 (15.7) | 93 (13.5) |
| Asia-Pacific | 162 (46.8) | 160 (46.5) | 322 (46.7) |
| Europe | 55 (15.9) | 44 (12.8) | 99 (14.3) |
| Latin America | 90 (26.0) | 86 (25.0) | 176 (25.5) |
| Median time since diagnosis (IQR), mo | 6.2 (2.4–13.3) | 6.5 (2.28–13.2) | 6.4 (2.3–13.3) |
| Etiology of PAH, n (%) | |||
| Idiopathic or heritable PAH | 219 (63.3) | 216 (62.8) | 435 (63.0) |
| Connective tissue disease | 94 (27.2) | 84 (24.4) | 178 (25.8) |
| HIV infection | 2 (0.6) | 7 (2.0) | 9 (1.3) |
| Congenital heart defect | 20 (5.8) | 27 (7.8) | 47 (6.8) |
| Other | 11 (3.2) | 10 (2.9) | 21 (3.0) |
| 6MWD, n (%) | |||
| ≤350 m | 95 (27.5) | 93 (27.0) | 188 (27.2) |
| >350 m | 251 (72.5) | 251 (73.0) | 502 (72.8) |
| 6MWD, m | 392.9 ± 92.5 | 398.5 ± 100.0 | 395.7 ± 96.3 |
| WHO functional class at baseline, n (%) | |||
| I | 9 (2.6) | 13 (3.8) | 22 (3.2) |
| II | 205 (59.2) | 228 (66.3) | 433 (62.8) |
| III | 131 (37.9) | 103 (29.9) | 234 (33.9) |
| IV | 1 (0.3) | 0 | 1 (0.1) |
| Background PAH therapy at baseline, n (%) | |||
| PDE5 inhibitor or SGC stimulator alone | 248 (71.7) | 246 (71.5) | 494 (71.6) |
| ERA alone | 98 (28.3) | 98 (28.5) | 196 (28.4) |
| Median time on background PAH therapy at baseline (IQR), mo | 5.3 (2.3–10.7) | 5.5 (2.4–10.6) | 5.4 (2.4–10.7) |
| Risk stratification by number of low-risk criteria met†‡, n (%) | — | ||
| 0 | 85 (25.2) | 59 (17.7) | |
| 1 | 112 (33.2) | 110 (32.9) | |
| 2 | 102 (30.3) | 94 (28.1) | |
| 3 | 38 (11.3) | 71 (21.3) |
Definition of abbreviations: 6MWD = 6-minute-walk distance; ERA = endothelin receptor antagonist; IQR = interquartile range; PAH = pulmonary arterial hypertension; PDE5 = phosphodiesterase type 5; SGC = soluble guanylate cyclase; WHO = World Health Organization.
Plus/minus values are means ± SD. Testing of baseline characteristics showed that there were no significant between-group differences at baseline, except regarding risk stratification by number of low-risk criteria.
Low-risk criteria defined as WHO functional class I or II, 6MWD greater than 440 m, and/or N-terminal pro–brain natriuretic peptide less than 300 pg/ml. Low-risk criteria met were only counted for subjects with all three measures available; n = 337 oral treprostinil, n = 334 placebo.
P = 0.002; P value was obtained from Fisher’s exact test.