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Table 2 Changes of clinical parameters from baseline to 6 months

From: Early treatment with ambrisentan of mildly elevated mean pulmonary arterial pressure associated with systemic sclerosis: a randomized, controlled, double-blind, parallel group study (EDITA study)

Parameter [unit] Placebo Ambrisentan 95% CI of difference
Changes (n = 15) Changes (n = 17)
Baseline–6 months Baseline–6 months
Mean ± SD 95% CI n Mean ± SD 95% CI n
Hemodynamics at rest
 CVP [mmHg] − 0.20 ± 2.76 (− 1.73 to 2.94)   0.82 ± 4.11 (− 1.29 to 2.94)   (− 1.54 to 3.59)
 mPAP [mmHg] − 0.73 ± 3.59 (− 2.72 to 1.26)   − 1.00 ± 6.40 (− 4.29 to 2.29)   (− 4.09 to 3.56)
 PAWP [mmHg] 0.13 ± 3.20 (− 1.64 to 1.91)   1.24 ± 5.31 (− 1.50 to 3.97)   (− 2.12 to 4.32)
 CO [l/min] − 0.26 ± 1.11 (−  0.88 to 0.36)   0.58 ± 1.17 (− 0.03 to 1.18)   (0.01 to 1.66)
 CI [l/min/m2] − 0.31 ± 0.71 (− 0.71 to 0.08)   0.36 ± 0.66 (0.01 to 0.71) (16) (0.18 to 1.18)
 SvO2 [%] − 3.48 ± 12.26 (− 10.89 to 3.93) (13)# − 2.79 ± 7.56 (− 7.60 to 2.01) (12)# (− 7.83 to 9.20)
 PVR [WU] 0.02 ± 0.76 (− 0.48 to 0.43)   − 0.59 ± 0.79 (− 1.05 to − 0.14)   (− 1.25 to − 0.17)
Hemodynamics at peak exercise
 mPAP [mmHg] 1.08 ± 7.39 (− 3.39 to 5.54) (13) − 0.73 ± 6.23 (− 4.18 to 2.71) (15) (− 7.10 to 3.48)
 PAWP [mmHg] 0.85 ± 6.3 (− 2.96 to 4.65) (13) 4.93 ± 6.52 (1.16 to 8.69) (14) (− 1.01 to 9.17)
 CO [l/min] − 0.05 ± 1.46 (− 0.94 to 0.83) (13) 1.24 ± 1.47 (0.43 to 2.05) (15) (0.15 to 2.44)
 CI [l/min/m2] − 0.45 ± 1.36 (− 1.27 to 0.37) (13) 0.70 ± 0.81 (0.25 to 1.15) (15) (0.29 to 2.00)
 SvO2 [%] − 28.35 ± 10.5 (− 35.41 to − 21.30) (11) − 30.05 ± 17.73 (− 42.73 to − 17.37) (10) (− 14.85 to 11.46)
 Workload [Watt] 1.92 ± 16.01 (− 7.75 to 11.60) (13) 5.00 ± 16.9 (− 4.36 to 14.36) (15) (− 9.77 to 15.93)
 HR max [b/min] 6.00 ± 18.74 (− 5.32 to 17.32) (13) 7.47 ± 12.01 (0.82 to 14.12) (15) (− 10.59 to 13.53)
 PVR [WU] − 0.003 ± 0.34 (− 0.21 to 0.21) (13) − 0.84 ± 0.48 (− 1.12 to − 0.57) (14) (− 1.17 to − 0.51)
 TPR [mmHg min L− 1] 0.16 ± 0.63 (− 0.22 to 0.54) (13) − 0.56 ± 0.48 (− 0.83 to − 0.29) (15) (− 1.16 to − 0.29)
6MWD
 6MWD [m] − 16.53 ± 77.32 (− 59.35 to 26.29)   21.53 ± 34.6 (3.74 to 39.31)   (− 4.30 to 80.43)
 Borg dyspnea score 0.08 ± 1.54 (− 0.77 to 0.93)   0.62 ± 1.7 (− 0.25 to 1.50)   (− 0.63 to 1.72)
 SaO2 after 6MWD [%] 1.30 ± 5.1 (− 2.35 to 4.95) (10)# 2.07 ± 5.7 (− 1.22 to 5.37) (14) (− 3.92 to 5.46)
 HR after 6MWD [/min] 6.83 ± 24.97 (− 9.04 to 22.70) (12)# − 1.53 ± 18.43 (− 11.74 to 8.68) (15) (− 25.56 to 8.83)
Quality of life SF-36
 Physical functioning − 2.00 ± 25.20 (− 15.96 to 11.96)   − 7.65 ± 21.66 (− 18.78 to 3.49)   (− 22.56 to 11.27)
 Physical role functioning 13.33 ± 38.81 (− 8.12 to 34.82)   − 10.29 ± 42.44 (− 32.12–11.53)   (− 53.14 to 5.88)
 Bodily pain − 2.47 ± 28.19 (− 18.08 to 13.15)   − 9.29 ± 23.87 (− 21.57 to 2.98)   (− 25.62 to 11.97)
 General health perceptions 0.20 ± 19.39 (− 10.54 to 10.94)   − 2.71 ± 10.62 (− 8.17 to 2.75)   (− 14.01 to 8.20)
 Vitality − 5.00 ± 16.37 (− 14.06 to 4.06)   − 3.53 ± 12.34 (− 9.88 to 2.82)   (− 8.92 to 11.86)
 Social role functioning 0.87 ± 27.69 (− 14.47 to 16.20)   − 2.18 ± 19.21 (− 12.05 to 7.70)   (− 20.08 to 13.99)
 Emotional role functioning 8.80 ± 49.68 (− 18.71 to 36.31)   − 9.82 ± 36.76 (− 28.73 to 9.08)   (− 49.93 to 12.68)
 Mental health − 3.73 ± 11.85 (− 10.30 to 2.83)   − 4.47 ± 10.94 (− 10.10 to 1.16)   (− 8.97 to 7.49)
 Physical health score 0.87 ± 16.01 (− 8.00 to 9.73)   − 6.71 ± 12.17 (− 12.97 to − 0.45)   (− 17.77 to 2.62)
 Mental health score 0.27 ± 19.77 (− 10.68 to 11.22)   − 4.65 ± 9.47 (− 9.51 to 0.22)   (− 15.89 to 6.06)
 mRSS 0.73 ± 2.15 (− 0.46 to 1.93)   0.24 ± 0.97 (− 0.26 to 0.73)   (− 1.68 to 0.68)
Lung function
 FVC [%] − 1.04 ± 5.60 (− 4.15 to − 2.06)   − 3. 31 ± 5.56 (− 6.27 to − 0.34) (16) (− 6.37 to 1.84)
 FEV1 [L] − 0.06 ± 0.20 (− 0.17 to 0.05)   − 0.11 ± 0.21 (− 0.22 to 0.01) (16) (− 0.20 to 0.11)
 FEV1% VC max [%] − 0.67 ± 4.50 (− 3.16 to 1.82)   − 4.17 ± 7.12 (− 7.97 to − 0.38) (16) (− 7.91 to 0.91)
 PEF [l/s] −0.22 ± 1.76 (−1.12 to 0.76)   0.01 ± 1.15 (−0.61 to 0.62) (16) (−0.86 to 1.31)
 TLC [l] − 0.03 ± 0.36 (− 0.23 to 0.17)   − 0.06 ± 0.37 (− 0.26 to 0.14) (16) (− 0.30 to 0.24)
 Residual volume [l] 0.05 ± 0.37 (− 0.16 to 0.25)   − 0.03 ± 0.33 (− 0.20 to 0.15) (16) (− 0.33 to 1.83)
 DLCO [mmol/min/kPa] − 0.45 ± 1.70 (− 1.48 to 0.57) (13) − 0.32 ± 1.44 (− 1.06 to 0.42)   (− 1.04 to 1.30)
 DLCO % predicted − 0.44 ± 1.84 (− 1.55 to 0.67) (13) 1.19 ± 1.81 (0.26 to 2.12) (17) (25.10 to 30.04)
 SaO2 [%] 0.15 ± 1.86 (− 0.88 to 1.18)   − 0.62 ± 1.50 (− 1.39 to 0.16)   (− 1.99 to 0.44)
 PaO2 [mmHg] 1.69 ± 9.95 (− 3.82 to 7.21)   − 4.88 ± 7.60 (− 8.78 to − 0.97)   (− 12.92 to − 0.22)
 PaCO2 [mmHg] − 0.03 ± 2.63 (− 1.48 to 1.43)   − 0.65 ± 2.77 (− 2.08 to 0.77)   (− 2.58 to 1.33)
Echocardiography
 Estimated sPAP [mmHg] − 0.93 ± 6.08 (− 4.30 to 2.43)   − 0.82 ± 4.46 (− 3.11 to 1.47)   (− 3.71 to 3.93)
 RA area [cm2] − 0.47 ± 4.07 (− 2.72 to 1.79)   1.65 ± 2.67 (0.28 to 3.01)   (− 0.34 to 4.57)
 RV area [cm2] − 0.80 ± 3.05 (− 2.49 to 0.89)   − 0.15 ± 3.46 (− 1.93 to 1.63)   (− 1.72 to 3.02)
 TAPSE [cm] − 0.19 ± 0.54 (− 0.49 to 0.11)   0.12 ± 0.41 (− 0.09 to 0.33)   (− 0.04 to 0.65)
Laboratory
 Hemoglobin [g/dl] 0.19 ± 0.68 (− 0.19 to 0.56)   − 0.59 ± 0.86 (− 1.03 to − 0.15)   (− 1.34 to − 0.21)
 Hematocrit [l/l] 0.00 ± 0.02 (− 0.009 to 0.02)   − 0.01 ± 0.02 (− 0.03 to − 0.0001)   (− 0.03 to 0.00)
 Platelets [100/nl] − 0.08 ± 0.39 (− 0.29 to 0.14)   − 0.15 ± 0.37 (− 0.34 to 0.04)   (− 0.35 to 0.20)
 Creatinine [mg/dl] − 0.03 ± 0.09 (− 0.08 to 0.02)   − 0.04 ± 0.11 (− 0.09 to 0.02)   (− 0.08 to 0.07)
 Potassium [mmol/l] 0.09 ± 0.40 (− 0.13 to 0.31)   − 0.06 ± 0.62 (− 0.38 to 0.26)   (− 0.53 to 0.24)
 AST [U/l] − 4.40 ± 13.94 (− 12.12 to 3.32)   3.59 ± 7.96 (− 0.51 to 7.68)   (− 0.08 to 16.06)
 ALT [U/l] − 4.93 ± 15.01 (− 13.25 to 3.38)   5.12 ± 7.83 (1.09 to 9.15)   (1.56 to 18.55)
 LDH [U/l] − 7.00 ± 27.36 (− 22.15 to 8.15)   2.82 ± 29.57 (− 12.38 to 18.03)   (− 10.84 to 30.49)
 CK [U/l] 9.21 ± 40.50 (− 14.17 to 32.60) (14) 5.53 ± 36.80 (− 13.39 to 24.45)   (− 32.10 to 24.73)
 CRP [mg/l] − 1.08 ± 3.52 (− 3.03 to 0.87)   − 2.71 ± 12.17 (− 8.97 to 3.54)   (− 8.29 to 5.03)
 NTproBNP [pg/ml] 31.00 ± 85.83 (− 20.87 to 82.87) (13) − 15.63 ± 207.48 (− 126.18 to 94.93) (16) (−  172.95 to 79.70)
  1. SD standard deviation, CVP central venous pressure, mPAP mean pulmonary arterial pressure, PAWP pulmonary capillary wedge pressure, CO cardiac output, CI cardiac index, SvO2 venous oxygen saturation, PVR pulmonary vascular resistance, WU Wood Units, HR heart rate, b beats, min minute, TPR total pulmonary resistance, 6MWD Six-minute walking distance, SaO2 oxygen saturation, HR heart rate, mRSS modified Rodnan Skin Score, FVC forced vital capacity, FEV1 forced expiratory volume in first second, VC vital capacity, PEF peak expiratory flow, TLC total lung capacity, DLCO diffusing capacity of the lung for carbon monoxide, SaO2 oxygen saturation, PaO2 partial pressure of oxygen, PaCO2 partial pressure of carbon dioxide, sPAP systolic pulmonary arterial pressure, RA right atrial, RV right ventricular, TAPSE tricuspid annular plane systolic excursion, AST aspartate-aminotransferase, ALT alanine-aminotransferase, LDH lactate dehydrogenase, CK creatine kinase, CRP C-reactive protein, NTproBNP N-terminal pro-brain natriuretic peptide
  2. In case of missing data, sample sizes are given in brackets
  3. #Values with more than 20% missing data