TABLE 3 ] .
Baseline Values (± SD) and Changes (Least Squares Mean) From Baseline in Secondary Hemodynamic Parameters
Parameter | Placebo (n = 11) | Riociguat | Treatment Difference (95% CI)a | ||||||
0.5 mg (n = 8) | 1 mg (n = 7) | 2 mg (n = 10) | |||||||
Baseline | Change | Baseline | Change | Baseline | Change | Baseline | Change | ||
Cardiac index, L/min/m2 | 2.2 ± 0.8 | 0.04 | 2.7 ± 0.5 | 0.1 | 2.6 ± 0.9 | 0.3 | 2.5 ± 0.5 | 0.5 | 0.4 (0.2 to 0.7) |
P = .001 | |||||||||
Cardiac output, L/min | 4.2 ± 1.9 | 0.08 | 5.0 ± 0.7 | 0.3 | 5.2 ± 1.9 | 0.6 | 4.9 ± 1.5 | 1.0 | 0.9 (0.3 to 1.4) |
P = .002 | |||||||||
Diastolic BP, mm Hg | 62.3 ± 11.9 | −2.4 | 57.4 ± 9.7 | −2.4 | 61.0 ± 10.2 | −5.8 | 58.7 ± 11.2 | −8.7 | −6.3 (−11.8 to −0.7) |
P = .03 | |||||||||
Systolic BP, mm Hg | 129.5 ± 20.2 | −2.1 | 143.3 ± 19.3 | −2.8 | 144.7 ± 22.8 | −16.3 | 141.6 ± 24.9 | −13.7 | −11.7 (−22.4 to −0.9) |
P = .03 | |||||||||
Heart rate, bpm | 66.1 ± 14.1 | 2.3 | 63.4 ± 12.2 | 0.9 | 73.0 ± 28.5 | −0.2 | 67.5 ± 7.6 | 4.6 | 2.3 (−4.4 to 9.0) |
P = .5 | |||||||||
Stroke volume, mL | 66.6 ± 34.0 | 0.6 | 81.5 ± 18.0 | 5.2 | 77.8 ± 36.7 | 4.0 | 75.1 ± 27.1 | 9.4 | 8.8 (0.4 to 17.3) |
P = .04 | |||||||||
Stroke volume index, mL/m2 | 34.2 ± 14.3 | 0.4 | 42.9 ± 7.9 | 2.6 | 39.1 ± 17.1 | 2.2 | 38.4 ± 10.4 | 4.6 | 4.2 (−0.1 to 8.4) |
P = .05 | |||||||||
Systemic vascular resistance, dyn/s/cm5 | 1,583 ± 689 | −90 | 1,246 ± 392 | −113 | 1,352 ± 795 | −366 | 1,294 ± 481 | −336 | −247 (−490 to −4) |
P < .05 | |||||||||
Systemic vascular resistance index, dyn/s/cm5/m2 | 2,938 ± 1127 | −170 | 2,356 ± 797 | −229 | 2,581 ± 1,379 | −691 | 2,398 ± 633 | −624 | −455 (−905 to −4) |
P < .05 | |||||||||
Pulmonary vascular resistance, dyn/s/cm5 | 303.5 ± 168.8 | −4.6 | 217.1 ± 60.5 | −5.7 | 223.7 ± 169.5 | −28.2 | 227.7 ± 105.7 | −20.8 | −16.2 (−78.2 to 45.9) |
P = .6 | |||||||||
Pulmonary vascular resistance index, dyn/s/cm5/m2 | 554.5 ± 265.6 | −6.4 | 417.5 ± 140.6 | −13.1 | 435.9 ± 317.4 | −53.2 | 425.0 ± 178.0 | −39.4 | −33.0 (−147.2 to 81.3) |
P = .6 | |||||||||
Pulmonary arterial wedge pressure, mm Hg | 21.1 ± 6.4 | −2.8 | 18.6 ± 2.1 | −1.7 | 19.4 ± 2.1 | 0.1 | 21.8 ± 4.6 | −2.9 | −0.2 (−3.0 to 2.6) |
P = .9 | |||||||||
Right atrial pressure, mm Hg | 11.6 ± 3.0 | −0.9 | 9.5 ± 3.1 | −0.7 | 12.7 ± 4.6 | 0.5 | 11.7 ± 4.4 | −1.7 | −0.8 (−3.9 to 2.2) |
P = .6 | |||||||||
Mean arterial pressure, mm Hg | 83.9 ± 15.9 | −4.3 | 85.0 ± 11.9 | −4.1 | 86.0 ± 13.1 | −9.3 | 85.6 ± 14.8 | −12.3 | −8.0 (−15.5 to −0.6) |
P = .04 | |||||||||
Mixed venous oxygen saturation, % | 60.4 ± 7.8 | 1.2 | 66.6 ± 7.3 | −1.1 | 67.8 ± 5.4b | 3.1 | 64.3 ± 5.3c | 2.5 | 1.3 (−3.2 to 5.8) |
P = .6 | |||||||||
Transpulmonary pressure gradient, mm Hg | 13.8 ± 5.6 | −0.1 | 13.4 ± 3.1 | 0.4 | 11.7 ± 4.9 | 0.9 | 13.3 ± 6.3 | 0.7 | 0.8 (−2.2 to 3.9) |
P = .6 |
The mean changes from baseline of all evaluations up to 6 h after study drug administration are shown. bpm = beats/min.
Riociguat 2 mg vs placebo.
n = 6.
n = 9.