Table 1.
Demographics and pharmacokinetic parameters
| Demographic or pharmacokinetic parametera | Mean ± SDb |
|||
|---|---|---|---|---|
| Ambulatory (n = 3) | Hospitalized (n = 12) | Total (n = 15) | Normal wt in 2001 (n = 4)e | |
| Demographics | ||||
| Age (yr) | 35.3 ± 12.5 | 41.5 ± 11.8 | 38.4 ± 12.8 | NR |
| % Male | 67 | 50 | 53 | NR |
| Wt (kg) | 113.3 ± 12.3 | 161.9 ± 67.1 | 145.5 ± 59.4 | NR |
| BMI (kg/m2) | 37.4 ± 5.9 | 54.8 ± 23.5 | 49.3 ± 20.7 | NR |
| Obese classc | ||||
| Obese class I (n) | 1 | 1 | 2 | NR |
| Obese class II (n) | 1 | 3 | 4 | NR |
| Obese class III (n) | 1 | 8 | 9 | NR |
| SCR (mg/dl) | 0.8 ± 0.1 | 1.0 ± 0.3 | 0.98 ± 0.2 | NR |
| CLCR (ml/min) | ||||
| Estimated (Salazar-Corcoran) | 80.1 ± 13 | 99.2 ± 57.8 | 86.1 ± 41.8 | NR |
| Estimated (Cockroft-Gault/BSA) | 87.2 ± 11.7 | 82.2 ± 41.1 | 83.1 ± 36.9 | NR |
| Measured | 184.3 ± 20.8d | 135.6 ± 71 | 140.7 ± 64.4 | NR |
| Pharmacokinetics | ||||
| Cmax (mg/liter) | 7.84 ± 0.99 | 8.4 ± 1.8 | 8.2 ± 1.8 | 8.12 ± 0.99 |
| Ke (h−1) | 0.264 ± 0.069 | 0.100 ± 0.062 | 0.117 ± 0.0697 | NR |
| Half-life (h) | 2.63 ± 0.687 | 6.93 ± 4.27 | 5.92 ± 3.53 | 6.91 ± 0.83 |
| Vol of distribution (liters) | 79.4 ± 12.8 | 82.7 ± 20.5 | 83.8 ± 21.6 | 106 ± 12 |
| Vol of distribution (liters/kg [ABW]) | 0.7 ± 0.11 | 0.51 ± 0.13 | 0.58 ± 0.15 | NR |
| Vol of distribution (liters/kg [IBW]) | 1.2 ± 0.36 | 1.4 ± 0.76 | 1.3 ± 0.69 | NR |
| Systemic clearance (ml/min) | 348.8 ± 3.5 | 139.7 ± 70.4 | 163.3 ± 70.45 | 186 ± 5 |
| AUC0–24 (mg/liter·h) | 36.8 ± 6.4 | 90.12 ± 40.8 | 76.55 ± 32.96 | 61.1 ± 1.3 |
a
BMI, body mass index; CLCR, creatinine clearance; SCR, serum creatinine; ABW, actual body weight; IBW, ideal body weight (9).
b
All values are reported as means ± the standard deviation except as noted in column 1. NR, not reported.
c
Obese class I, BMI 30 to 35; class II, BMI 35 to 40; class III, BMI >40 (24).
d
P < 0.05 measured versus the estimated CLCR determined by the Salazar-Corcoran method and by the Cockcroft-Gault method standardized using the body surface area (BSA).
e
According to Chow et al. (7).