TABLE 1

Baseline characteristics in placebo and bosentan groups

PlaceboBosentanAll
Patients n175159334
Sex
 Female128 (73.1)125 (78.6)253 (75.7)
 Male47 (26.9)34 (21.4)81 (24.3)
Age years
 Mean±sd54.7±15.752.9±15.453.9±15.6
 Median (interquartile range)56.0 (41.0–68.0)55.0 (40.0–65.0)55.0 (40.0–66.0)
BMI# kg·m−2
 Mean±sd29.1±6.9528.5±6.8328.8±6.9
 Median (interquartile range)28.2 (24.5–32.8)27.5 (23.9–32.2)28.0 (24.1–32.8)
Geographical region
 USA83 (47.4)73 (45.9)156 (46.7)
 Europe56 (32.0)50 (31.4)106 (31.7)
 Brazil35 (20.0)36 (22.6)71 (21.3)
 Saudi Arabia1 (0.6)1 (0.3)
Time from PAH diagnosis months
 Mean±sd26.2±51.225.3±47.325.7±49.4
 Median (interquartile range)11.4 (6.0–24.9)12.2 (6.6–28.4)12.1 (6.3–26.0)
Aetiology of PAH
 Idiopathic114 (65.1)99 (62.3)213 (63.8)
 Familial2 (1.1)3 (1.9)5 (1.5)
 Connective tissue disease45 (25.7)43 (27.0)88 (26.3)
 Repaired congenital shunts11 (6.3)9 (5.7)20 (6.0)
 Drugs and toxins3 (1.7)5 (3.1)8 (2.4)
6-min walk distance m
 Mean±sd357.6±73.1363.1±78.5360.3±75.7
 Median (interquartile range)372.0 (305–410)385.0 (306–423)375.5 (306–416)
WHO functional class
 II69 (39.4)71 (44.7)140 (41.9)
 III104 (59.4)88 (55.3)192 (57.5)
 IV2 (1.1)2 (0.6)
NT-proBNP pmol·L−1
 Mean±sd170.1±239.4189.7±384.0179.6±317.2
 Median (interquartile range)56.6 (21.6–208.5)54.3 (19.4–201.0)54.9 (19.7–202.6)
Baseline sildenafil dose mg
 Mean±sd81.1±45.177.8±48.579.6±46.7
 Median (interquartile range)60 (60–75)60 (60–60)60 (60–60)
  • Data are presented as n (%) unless otherwise stated. BMI: body mass index; PAH: pulmonary arterial hypertension; WHO: World Health Organization; NT-proBNP: N-terminal pro-brain natriuretic peptide. #: placebo, n=172; bosentan, n=157. : placebo, n=117; bosentan, n=110.