Table 1.
Variable | Placebo |
Ambrisentan (10 mg/day) |
p | ||
---|---|---|---|---|---|
−SPIRO (n = 111) | +SPIRO (n = 21) | −SPIRO (n = 57) | +SPIRO (n = 10) | ||
Age (yrs) | 50 (18–81) | 47 (27–69) | 50 (18–78) | 47 (24–78) | 0.58 |
Women | 87 (78.4%) | 16 (76.2%) | 45 (78.9%) | 8 (80.0%) | 1.00 |
Race | |||||
Caucasian | 84 (75.7%) | 16 (76.2%) | 35 (61.4%) | 9 (90.0%) | 0.15 |
Black | 4 (3.6%) | 0 | 2 (3.5%) | 1 (10.0%) | |
Asian | 4 (3.6%) | 0 | 1 (1.8%) | 0 | |
Hispanic | 19 (17.1%) | 5 (23.8%) | 17 (29.8%) | 0 | |
Other | 0 | 0 | 2 (3.5%) | 0 | |
Pulmonary arterial hypertension origin | |||||
Primary pulmonary hypertension | 66 (59.5%) | 19 (90.5%) | 34 (59.6%) | 7 (70%) | 0.73 |
Nonprimary pulmonary hypertension (CTD; HIV; Anorexigen) |
45 (40.5%) | 2 (9.5%) | 23 (40.4%) | 3 (30%) | |
Baseline WHO functional class | |||||
I | 4 (3.6%) | 0 | 2 (3.5%) | 0 | 0.31 |
II | 40 (36.0%) | 7 (33.3%) | 20 (35.1%) | 2 (20%) | |
III | 55 (58.6%) | 13 (61.9%) | 31 (54.4%) | 5 (50%) | |
IV | 2 (1.8%) | 1 (4.8%) | 4 (7.0%) | 3 (30%) | |
Borg dyspnea index | 3.8 ± 2.1 | 4.3 ± 2.4 | 3.8 ± 2.1 | 3.8 ± 2.1 | 0.95 |
6-MWD (m) | 346.7 ± 75.3 | 318.9 ± 97.7 | 344.8 ± 79.0 | 322.3 ± 74.9 | 0.41 |
Cardiac index (L/min/m2) | 2.4 ± 0.8 | 2.4 ± 0.8 | 2.6 ± 0.7 | 2.4 ± 0.8 | 0.44 |
Pulmonary vascular resistance (Wood units) | 11.3 ± 6.8 | 12.6 ± 7.2 | 10.8 ± 5.7 | 14.5 ± 6.0 | 0.07 |
Mean pulmonary artery pressure (mm Hg) | 49.7 ± 14.2 | 57.0 ± 12.7 | 50.4 ± 15.5 | 57.4 ± 19.0 | 0.21 |
Mean right atrial pressure (mm Hg) | 7.5 ± 4.8 | 9.4 ± 5.9 | 8.8 ± 5.0 | 11.2 ± 8.7 | 0.22 |
Plasma B-type natriuretic peptide (ng/L) | 130.8 (99.1–172.7) | 142.4 (78.9–257.2) | 131.7 (88.0–197.2) | 236.7 (81.5–687.4) | 0.24 |
Values are mean ± SD as appropriate, except for age, which is reported as mean and range. Values for plasma B-type brain natriuretic peptide are geometric mean (95% CI). p Values compare ambrisentan (n = 49 for BNP, n = 54 for pulmonary vascular resistance and mean right atrial pressure, n = 55 for cardiac index, and n = 57 for other variables) and ambrisentan + spironolactone (n = 10) treatment groups. p Value for race compares Caucasian and non-Caucasian. p Value for WHO functional class compares I/II and III/IV.
CTD = connective tissue disease; HIV = human immunodeficiency virus; SPIRO = spironolactone; WHO = World Health Organization.