Table 2.
Median % changes (range minimum-maximum) in haemodynamic parameters during right heart catheterization from baseline to 60 min and the pharmacokinetic parameters of vardenafil after a single oral dose
| n | Baseline median (min, max) | 60 min median (min, max) | *Change (%) median (min, max) | P value1 | |
|---|---|---|---|---|---|
| Heart rate (beats min−1) | 16 | 71 (56, 94) | 72 (50, 102) | −0.9 (−19.2, 19.4) | 0.978 |
| Aortic pressure (mmHg) | 14 | 135 (118, 224) | 127.50 (104, 321) | −5.8 (−26.2, 122.9) | 0.153 |
| Mean aortic pressure (mmHg) | 14 | 94 (81, 139) | 88 (68, 119) | −6.0 (−27.0, 2.1) | <0.001 |
| Systolic PAP (mmHg) | 16 | 65.50 (41, 98) | 52.50 (26, 89) | −17.2 (−36.6, 3.8) | <0.001 |
| mPAP (mmHg) | 16 | 40 (29, 65) | 34.50 (15, 58) | −20.3 (−48.3, 3.0) | <0.001 |
| mPAWP (mmHg) | 16 | 11 (4, 32) | 10.50 (3, 32) | 0.0 (−40.0, 50.0) | 0.977 |
| mRAP (mmHg) | 16 | 8.50 (2, 28) | 6.50 (1, 23) | −13.1 (−83.3, 100.0) | 0.720 |
| CO (l min−1) | 16 | 3.95 (2.10, 5.83) | 4.95 (2.60, 7.90) | 10.6 (−25.0, 88.1) | 0.015 |
| CI (l min−1 m−2) | 16 | 2.30 (1.40, 3.40) | 2.75 (1.70, 4.50) | 12.1 (−24.0, 94.4) | 0.010 |
| PVR (dyn .s cm−5) | 16 | 612 (192, 1144) | 404 (80, 816) | −28.9 (−61.5, −5.9) | <0.001 |
| SVR (dyn .s cm−5) | 14 | 1852 (848, 2968) | 1444 (640, 2248) | −20.6 (−61.2, 1.7) | <0.001 |
| PVR : SVR | 14 | 0.28 (0.09, 0.53) | 0.25 (0.09, 0.50) | −16.9 (−49.0, 16.5) | 0.002 |
| PA sat (%) | 13 | 60.50 (45.90, 69.40) | 62.45 (51, 76.50) | 2.6 (−7.7, 36.1) | 0.168 |
| Art sat (%) | 11 | 91.20 (85, 93.70) | 90.40 (79.70, 96.55) | −1.3 (−6.6, 5.2) | 0.375 |
| Vardenafil concentration (µg l−1) | 16 | 5.07 (0.33, 39.6) | |||
| Vardenafil AUC(0,45 min) (µg l−1 h) | 15 | 2.53 (0.00, 17.9) | |||
| Vardenafil AUC(0,60 min) (µg l−1 h) | 15 | 3.88(0.04, 23.08) |
1
Wilcoxon's signed-rank test.
*
Values shown represent the median % change (with range minimum to maximum). m, mean; PAP, pulmonary artery pressure; PAWP, pulmonary arterial wedge pressure; RAP, right atrial pressure; CO, cardiac output; CI, cardiac index; PVR, pulmonary vascular resistance; SVR, systemic vascular resistance; PA, pulmonary artery; Art, arterial; AUC(0,45 min) and (0,60 min), area under the plasma concentration−time curve from time zero to 45 and 60 min, respectively.