Table 1 Baseline demographics and clinical characteristics
Placebo (n = 53) | Sildenafil (n = 50) | |
|---|---|---|
Men, n (%) | 12 (23) | 13 (26) |
Age, mean ± SD, y | 56.9 ± 14.1 | 55.2 ± 15.1 |
Ethnicity, n (%) | ||
White | 45 (85) | 44 (88) |
Asian | 2 (4) | 4 (8) |
Other or unspecified | 6 (11) | 2 (4) |
Primary diagnosis, n (%) | ||
IPAH/HPAH | 32 (60) | 35 (70) |
Duration since diagnosis, median (range), y | 1.3 (0.3–10.5) | 1.5 (0.4–19.3) |
APAH-CTD | 21 (40) | 15 (30) |
Duration since diagnosis, median (range), y | 2.0 (0.3–8.1) | 1.5 (0.3–7.2) |
Scleroderma | 19 | 10 |
Othera | 2 | 5 |
Bosentan treatment | ||
Dosage, n (%) | ||
62.5 mg BID | 3 (6) | 2 (4) |
125 mg BID | 49 (93) | 47 (94) |
Other or missing | 1 (2) | 1 (2) |
Duration, median (range), mo | 11.4 (3.1–90.9) | 11.2 (3.2–65.3) |
≤ 1 y, n (%) | 27 (51) | 26 (52) |
> 1 y, n (%) | 26 (49) | 24 (48) |
6MWD, mean ± SD, m | 350.4 ± 87.6 | 354.4 ± 73.1 |
<325 m, n (%) | 17 (32) | 15 (30) |
≥325 m, n (%) | 36 (68) | 35 (70) |
Strata (aetiology, baseline 6MWD), n (%) | ||
IPAH/HPAH, <325 m | 7 (13) | 10 (20) |
IPAH/HPAH, ≥325 m | 25 (47) | 25 (50) |
APAH-CTD, <325 m | 10 (19) | 5 (10) |
APAH-CTD, ≥325 m | 11 (21) | 10 (20) |
WHO functional class, n (%) | ||
II | 15 (28) | 20 (40) |
III | 38 (72) | 29 (58) |
IV | 0 | 1 (2) |
Borg dyspnoea score, mean ± SD, median (range) | 4.2 ± 1.9 4.0 (0.5–8.0) | 4.1 ± 2.3 4.0 (0–8.0) |
mPAP, mean ± SD, mmHg | 44.9 ± 13.3 | 46.9 ± 12.5 |