Table 1.
Baseline characteristics of randomized patients
| Variable | Oral treprostinil (N = 157) |
Placebo (N = 153) |
P value |
|---|---|---|---|
| Age, years | 52.0 (18.0–76.0) | 50.0 (20.0–75.0) | 0.470a |
| Female sex | 119 (75.8) | 122 (79.7) | 0.404 |
| PAH etiology: | 0.661b | ||
| Idiopathic or familial | 104 (66.2) | 99 (64.7) | |
| Connective tissue disease | 48 (30.6) | 49 (32.0) | |
| HIV infection | 2 (1.3) | 4 (2.6) | |
| Congenital heart disease | 3 (1.9) | 1 (.7) | |
| NYHA/WHO functional class:c | 0.217b | ||
| II | 43 (27.6) | 37 (24.3) | |
| III | 110 (70.5) | 115 (75.7) | |
| IV | 3 (1.9) | 0 (.0) | |
| 6MWD, m | 359.0 (150.0–422.0) | 355.0 (152.0–422.0) | 0.386a |
| NT-proBNP, pg/mLd | 712.0 (25.5–11,256.0) | 796.0 (25.5–20,456.0) | 0.392a |
| Background PAH therapy: | 0.840 | ||
| ERA | 25 (15.9) | 28 (18.3) | |
| PDE5I | 67 (42.7) | 65 (42.5) | |
| ERA + PDE5I | 65 (41.4) | 60 (39.2) | |
| Years since PAH diagnosis | 1.7 (0.0–15.0) | 1.9 (0.0–26.4) | 0.367a |
| Angiopoietin-2, ng/mLe | 9.3 (1.8–52.0) | 8.4 (2.5–43.0) | 0.638a |
| Soluble P-selectin, ng/mLe | 64.0 (21.0–146.0) | 67.0 (33.0–800.0) | 0.234a |
Note
Adapted from Tapson et al.25 Data are presented as median (range) or number (%). 6MWD: 6-minute walk distance; ERA: endothelin receptor antagonist; NT-proBNP: N-terminal pro-brain natriuretic peptide; NYHA: New York Heart Association; PAH: pulmonary arterial hypertension; PDE5I: phosphodiesterase 5 inhibitor; WHO: World Health Organization.
a
Nonparametric test (Mann-Whitney U test).
b
Fisher exact test.
c
Data available for 156 and 152 patients in the oral treprostinil and placebo groups, respectively.
d
Data available for 149 and 148 patients in the oral treprostinil and placebo groups, respectively.
e
Data available for 83 and 95 patients in the oral treprostinil and placebo groups, respectively.