Table 3.
Statistical Analysis of Unbound Evolocumab Pharmacokinetic Parameters After a Single Subcutaneous 140‐mg Dose of Evolocumab by Renal Function Group
| Parameter | Renal Function Group | N | LS Geometric Mean | LS Geometric Mean Ratio, % (90%CI)a | JT test P‐Valueb |
|---|---|---|---|---|---|
| Cmax (μg/mL) | Normal | 6 | 19.8 | .23 | |
| Severe renal impairment | 6 | 12.8 | 64.9 (38.4–109.6) | ||
| ESRD receiving hemodialysis | 5 | 13.2 | 66.6 (38.4–115.6) | ||
| AUClast (day × μg/mL) | Normal | 6 | 167.6 | .22 | |
| Severe renal impairment | 6 | 105.2 | 62.8 (31.9–123.4) | ||
| ESRD receiving hemodialysis | 5 | 109.0 | 65.1 (32.0–132.1) | ||
| AUCinf (day × μg/mL) | Normal | 6 | 178.8 | .77 | |
| Severe renal impairment | 3 | 183.6 | 102.7 (52.2–202.1) | ||
| ESRD receiving hemodialysis | 5 | 119.2 | 66.7 (37.3–119.1) |
AUClast, area under the drug concentration‐time curve from time zero to time of last quantifiable concentration; AUCinf, area under the drug concentration‐time curve from zero to infinity; CI, confidence interval; Cmax, maximum observed drug concentration; ESRD, end‐stage renal disease; JT, Jonckheere‐Terpstra; LS, least squares.
LS geometric mean from the SAS PROC MIXED procedure are based on natural log scale data converted back to the original scale. Ratio and CI are multiplied by 100 to express the RI group response as a percentage of the normal renal function group.
P‐value determined using the JT trend test. Group ordering for trend test: normal renal function, ESRD receiving hemodialysis, and severe RI.