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. Author manuscript; available in PMC: 2018 Jan 23.
Published in final edited form as: N Engl J Med. 2016 Nov 13;376(1):41–51. doi: 10.1056/NEJMoa1609243

Table 1.

Demographic and Clinical Characteristics of the Participants at Baseline (Safety Population).*

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.