Table 1.
Characteristic | Single-Dose Phase | Multiple-Dose Phase | ||||
---|---|---|---|---|---|---|
Placebo (N = 6) | Inclisiran (N = 18) | Placebo | Inclisiran | |||
with statin (N = 4)† | without statin (N = 8) | with statin (N = 9)‡ | without statin (N = 24) | |||
Age — yr | 48±14 | 46±10 | 58±3 | 51±14 | 54±16 | 51±12 |
Male sex — no. (%) | 2 (33) | 17 (94) | 2 (50) | 6 (75) | 4 (44) | 17 (71) |
Race — no. (%)§ | ||||||
White | 4 (67) | 12 (67) | 4 (100) | 7 (88) | 6 (67) | 19 (79) |
Other | 2 (33) | 6 (33) | 0 | 1 (12) | 3 (33) | 5 (21) |
Weight — kg | 70.6±12.0 | 77.1±7.7 | 74.3±5.1 | 77.6±10.3 | 77.7±17.0 | 74.7±11.7 |
Height — cm | 168±11 | 173±6 | 168±10 | 171±9 | 171±12 | 171±8 |
LDL cholesterol — mg/dl | 131.5±19.3 | 163.0±32.9 | 143.1±89.7 | 131.5±20.9 | 143.4±29.8 | 139.3±32.3 |
Triglycerides — mg/dl | 70.9±12.4 | 135.5±55.7 | 150.6±46.9 | 124.0±38.1 | 116.3±64.3 | 123.4±82.9 |
PCSK9 — μg/liter | 279.0±99.5 | 275.4±58.2 | 460.7±56.3 | 276.2±58.7 | 451.8±132.2 | 317.1±66.8 |
Plus–minus values are means ±SD. Two participants (one in the placebo group and one in the inclisiran group) in the multiple-dose phase did not receive the assigned regimen according to the protocol and were excluded from the pharmacodynamic analyses but were included in the safety population. To convert the values for low-density lipoprotein (LDL) cholesterol to millimoles per liter, multiply by 0.02586. To convert the values for triglycerides to millimoles per liter, multiply by 0.01129. PCSK9 denotes proprotein convertase subtilisin–kexin type 9.
Three participants were taking simvastatin at a dose of 40 mg per day, and one was taking pravastatin at a dose of 20 mg per day.
Four participants were taking atorvastatin at a dose of 40 mg per day, two at a dose of 20 mg per day, and one at a dose of 10 mg per day; one participant was taking simvastatin at a dose of 40 mg per day and one at a dose of 20 mg per day.
Race was self-reported.