Table 2.
Pitavastatin pharmacokinetic parameters
| Control (n = 6) | Child-Pugh A (n = 6) | Child-Pugh B (n = 6) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Median, range | Geomean | Median, range | Geomean | Geomean ratio 95% CI | Median, range | Geomean | Geomean ratio 95% CI | ||
| Cmax (ng ml−1) | 62.3 | 59.5 | 68.1 | 70.7 | 1.19 | 180.5 | 147.1 | 2.47 | P = 0.010 |
| 41.4–75.7 | 37.8–18.3 | 0.74–1.90 | 47.1–208.4 | 1.39–4.39 | |||||
| AUCt (ng ml−1) | 114.7 | 121.2 | 138.5 | 154.2 | 1.27 | 477.9 | 441.7 | 3.64 | P = 0.003 |
| 93.8–205.4 | 55.9–574.0 | 0.63–2.58 | 155.1–863.9 | 1.80–7.39 | |||||
| AUCinf (ng h ml−1) | 136.4 | 135.9 | 166.3 | 174.1 | 1.28 | 505.4 | 481.1 | 3.54 | P = 0.002 |
| 101.5–221.7 | 65.7–601.0 | 0.66–2.49 | 185.4–876.4 | 1.82–6.88 | |||||
| Tmax (h) | 0.5 | 0.67 | 0.5 | 0.56 | 0.83 | 0.5 | 0.56 | 0.83 | P = 0.608 |
| 0.5–1.5 | 0.5–1.0 | 0.53–1.30 | 0.5–1.0 | 0.53–1.30 | |||||
| t1/2 (h) | 10.0 | 7.0 | 9.0 | 8.3 | 1.18 | 13.8 | 14.4 | 2.06 | P = 0.06 |
| 2.8–11.1 | 3.2–19.3 | 0.64–2.19 | 12.2–18.8 | 1.11–3.82 | |||||
Geomean ratio = (Child-Pugh A or B geomean)/(Control geomean)
Cmax: maximum concentration of the drug in plasma, AUCt– the area under the plasmaconcentration-time curve from administration to last observed concentration of time, AUCinf: total area under the plasma concentration-time curve extrapolated from administration to infinite time, Tmax: time to reach maximum concentration of drug in plasma, t½: elimination half-time, SD: standard deviation, 95%CI: 95% confidence interval.