Table 4.

Changes from baseline to month 6 for hemodynamic parameters and NT-proBNP [16]

Variable	Combination therapy: macitentan 10 mg + background therapy (N = 24)		Monotherapy: placebo + background therapy (N = 34)		Mean treatment effect vs. placebo (95% CL)a
	n	Mean change ± SDb	n	Mean change ± SDb
Cardiac index, l/min/m2	22	0.28 ± 0.79	29	− 0.34 ± 0.52	0.61 (0.24, 0.98)c
PVR, %	22	75.5 (63.7–89.6)	29	119.7 (105.4–135.8)	− 36.9 (− 48.5 to − 22.7)c
mPAP, mmHg	22	− 3.3 ± 7.9	29	1.1 ± 6.7	− 4.4 (− 8.5, − 0.3)c
NT-proBNP, fmol/ml	21	− 228.8 ± 501	28	37.5 ± 321.9	− 266 (− 503, − 29)c

N represents the number of patients in the hemodynamic sub-study at baseline who were receiving background PAH therapy; n represents the number of patients receiving background PAH therapy with non-missing values for the change from baseline to month 6. Results are based on observed data with no imputation rules applied for missing values

CL confidence limit, mPAP mean pulmonary arterial pressure, NT-proBNP N-terminal pro-brain natriuretic peptide, PVR pulmonary vascular resistance, SD standard deviation

^aPVR data are expressed as a percent change (%) between macitentan and placebo: (ratio of geometric means − 1) × 100, data for all other variables are the placebo corrected mean ± SD

^bPVR data are the geometric mean of month 6/baseline (%) (95% CL), data for all other variables are mean ± SD

^c P value < 0.05 for the comparison between macitentan and placebo