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. 2017 Feb 28;38(15):1147–1155. doi: 10.1093/eurheartj/ehx025

Table 2.

Changes from baseline to month 6 and values at month 6 for haemodynamic parameters and NT-proBNP

Placebo
 Macitentan 3 mg
 Macitentan 10 mg
n Mean change from baseline ±SDa Mean  ± SD at month 6 n Mean change from baseline ± SDa Mean  ± SD at month 6 Mean treatment effect vs. placebo (95% CL)b n Mean change from baseline ±SDa Mean±SD at month 6 Mean treatment effect vs. placebo (95% CL)b
CI, L/min/m2 50 −0.33  ± 0.65 2.21  ± 0.63 47 0.36  ± 0.57 2.69  ± 0.83 0.69  (0.44, 0.93)* 48 0.30  ± 0.85 2.93  ± 0.73 0.63  (0.33,0.93)*
RAP, mmHg 50 0.2  ± 4.5 8.1  ± 5.7 47 −0.3  ± 5.5 8.8  ± 5.2 −0.5  (−2.5, 1.5) 49 −0.6  ± 4.8 7.7  ± 5.5 −0.8  (−2.7, 1.0)
mPAP, mmHg 50 1.0  ± 7.4 54.3  ± 21.4 47 −3.4  ± 7.9 49.3  ± 15.9 −4.4  (−7.5, −1.3)* 49 −5.3  ± 11.4 47.5  ± 19.9 −6.4  (−10.2, −2.5)*
PVR, dyn·sec/cm5 50 115.8  (104.7, 128.1) 1042  ± 656 47 76.9  (69.8, 84.6) 736  ± 434 −33.6  (−42.2, −23.8)* 48 71.3  (62.4, 81.4) 680  ± 497 −38.5  (−47.8, −27.5)*
SvO2, % 48 −2.0  ± 6.2 64.8  ± 8.6 40 0.8  ± 7.2 64.8  ± 7.2 2.7  (−0.1, 5.6) 45 0.1  ± 6.9 66.0  ± 8.2 2.0  (−0.7, 4.7)
NT−proBNP, fmol/ml 49 194  ± 575 1451  ± 1258 45 −168  ± 633 1280  ± 958 −362  (−610, −115)* 46 −109  ± 552 1064  ± 891 −303  (−533, −73)*
*

P-value < 0.05 for the comparison between macitentan and placebo.

a

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

b

PVR 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.

n represents the number of patients in the haemodynamic sub-study with non-missing values for change from baseline to month 6. Results are based on observed data with no imputation rules applied for missing values.

CI, cardiac index; CL, confidence limits; mPAP, mean pulmonary arterial pressure; RAP, right atrial pressure; NT-proBNP, N-terminal pro-brain natriuretic peptide; PVR, pulmonary vascular resistance; SD, standard deviation; SvO2, mixed venous oxygen saturation.