Table 1.
Plasma Sildenafil and N-Desmethyl Sildenafil Concentrations in Two Subjects with CTP Class C Cirrhosis and Renal Dysfunction
| Subject 1 | Time after Sildenafil Injection (minutes) |
Sildenafil Concentration (ng/mL) |
N-desmethyl Sildenafil Concentration (ng/mL) |
Mean Arterial Pressure (mmHg)* |
Heart Rate* |
|---|---|---|---|---|---|
| 1 | Predose | BLQ | BLQ | 87 | 50 |
| 1 | 16 | 35.0 | 1.21 | 75 | 53 |
| 1 | 30 | 25.7 | BLQ | 78 | 53 |
| 1 | 60 | 25.9 | 2.26 | 78 | 55 |
| 1 | 88 | 31.9 | 2.10 | N/A | N/A |
| 1 | 120 | 21.6 | 2.49 | 75 | 51 |
| 1 | 178 | 23.5 | 2.64 | 79 | 50 |
| 1 | 242 | 26.7 | 2.19 | 78 | 50 |
| 1 | 360 | 5.01 | 2.00 | 83 | 53 |
| 1 | 480 | 3.87 | 1.53 | 83 | 54 |
| Subject 2 |
Time after Sildenafil Injection (minutes) |
Sildenafil Concentration (ng/mL) |
N-desmethyl Sildenafil Concentration (ng/mL) |
Mean Arterial Pressure (mmHg)* |
Heart Rate* |
| 2 | Predose | BLQ | BLQ | 77 | 98 |
| 2 | 15 | 20.6 | BLQ | 69 | 98 |
| 2 | 30 | 16.0 | BLQ | 73 | 98 |
| 2 | 60 | 13.5 | BLQ | 75 | 98 |
| 2 | 90 | 12.0 | BLQ | N/A | N/A |
| 2 | 122 | 12.0 | BLQ | 81 | 90 |
| 2 | 180 | 10.2 | 1.06 | 80 | 97 |
| 2 | 240 | 9.79 | BLQ | 75 | 93 |
| 2 | 360 | 7.08 | BLQ | 72 | 92 |
| 2 | 480 | 8.02 | BLQ | 75 | 94 |
BLQ=Below llimit of quantitation
*
At few time points, MAP and heart rate were measured 1 or 2 minutes earlier or later than plasma sildenafil and N-desmethyl sildenafil concentrations.