TABLE 9.
Renal function categoryb | Gender | Obesity | n | Covariate Valuea
|
PK parameter value
|
||||
---|---|---|---|---|---|---|---|---|---|
CrCL (ml/min) | IBW (kg) | Age (yr) | WTKG (kg) | AUCc (μg · h/ml) | Cmax (mg/liter) | ||||
Moderate (30-50 ml/min) | Male | Nonobese | 22 | 44 | 71 | 77 | 73 | 88.3 | 6.12 |
Obese | 5 | 45 | 66 | 75 | 92 | 80.8 | 5.52 | ||
Female | Nonobese | 15 | 43 | 50 | 74 | 54 | 115 | 8.69 | |
Obese | 17 | 45 | 45 | 67 | 73 | 104 | 7.49 | ||
Mild (51-80 ml/min) | Male | Nonobese | 67 | 67 | 69 | 67 | 75 | 79.9 | 5.77 |
Obese | 19 | 65 | 67 | 60 | 100 | 74.3 | 5.18 | ||
Female | Nonobese | 61 | 71 | 52 | 49 | 60 | 99.7 | 7.83 | |
Obese | 52 | 68 | 52 | 55 | 81 | 85.3 | 6.58 | ||
Normal (>80 ml/min) | Male | Nonobese | 133 | 107 | 77 | 41 | 80 | 67.7 | 5.24 |
Obese | 41 | 105 | 76 | 46 | 116 | 60.9 | 4.51 | ||
Female | Nonobese | 84 | 96 | 58 | 35 | 61 | 85.5 | 7.29 | |
Obese | 61 | 99 | 59 | 42 | 99 | 71.7 | 5.67 |
The covariate values represent the median patient covariates for each renal function category, subset by gender and obesity, rounded to the nearest integer.
There was an insufficient number of patients (n = 3) with severe renal function (15 to 29 ml/min) to perform this comparison.
CL (milliliters per minute) = (400 mg·103)/AUC (micrograms per hour per milliliter)·60.