Table 1. Demographic and Baseline Characteristics of Patients Who Entered the Open-Label Treatment Period (OLTP), Both Overall and According to Double-Blind (DB) Treatment Group.
| Characteristic | DB placebo IV Q4W (n = 31) | DB evinacumab, 5 mg/kg IV Q4W (n = 32) | DB evinacumab, 15 mg/kg IV Q4W (n = 33) | Total (n = 96) |
|---|---|---|---|---|
| Age, mean (SD), y | 55.7 (10.7) | 56.7 (10.0) | 51.1 (12.6) | 54.4 (11.3) |
| Sex, No. (%) | ||||
| Female | 17 (54.8) | 20 (62.5) | 15 (45.5) | 52 (54.2) |
| Male | 14 (45.2) | 12 (37.5) | 18 (54.5) | 44 (45.8) |
| Race, No. (%)a | ||||
| African American or Black | 2 (6.5) | 0 | 0 | 2 (2.1) |
| Asian | 1 (3.2) | 0 | 0 | 1 (1.0) |
| White | 25 (80.6) | 30 (93.8) | 31 (93.9) | 86 (89.6) |
| Otherb | 3 (9.7) | 2 (6.3) | 2 (6.1) | 7 (7.3) |
| Ethnicity, No. (%)a | ||||
| Hispanic or Latino | 2 (6.5) | 7 (21.9) | 1 (3.0) | 10 (10.4) |
| Not Hispanic or Latino | 29 (93.5) | 25 (78.1) | 32 (97.0) | 86 (89.6) |
| BMI, mean (SD)c | 29.0 (5.2) | 28.4 (3.9) | 28.7 (4.8) | 28.7 (4.6) |
| HeFH, No. (%) | 25 (80.6) | 26 (81.3) | 28 (84.8) | 79 (82.3) |
| By genotyping | 11 (35.5) | 10 (31.3) | 9 (27.3) | 30 (31.3) |
| By clinical diagnosis | 14 (45.2) | 16 (50.0) | 19 (57.6) | 49 (51.0) |
| Non-FH, No. (%) | 6 (19.4) | 6 (18.8) | 5 (15.2) | 17 (17.7) |
| CHD, No. (%) | 24 (77.4) | 17 (53.1) | 19 (57.6) | 60 (62.5) |
| Calculated LDL-C level, mean (SD), mg/dL | 147.8 (45.5) | 143.3 (63.1) | 146.6 (56.9) | 145.9 (55.2) |
| Total cholesterol level, mean (SD), mg/dL | 234.3 (50.5) | 226.1 (61.8) | 222.4 (59.1) | 227.5 (57.0) |
| Non–HDL-C level, mean (SD), mg/dL | 179.0 (48.1) | 167.3 (64.1) | 172.5 (55.5) | 172.8 (55.9) |
| HDL-C level, mean (SD), mg/dL | 55.3 (18.4) | 58.9 (19.7) | 49.9 (14.1) | 54.6 (17.8) |
| Fasting triglyceride level, median (IQR), mg/dL | 147.0 (104.0-200.0) | 101.5 (86.5-148.0) | 120.0 (91.0-166.0) | 122.0 (92.5-171.0) |
| ApoA1, mean (SD), mg/dL | 157.9 (29.2) | 163.3 (32.0) | 146.3 (26.5) | 155.8 (29.9) |
| ApoB, mean (SD), mg/dL | 118.3 (27.0) | 111.8 (35.7) | 114.6 (32.9) | 114.9 (31.9) |
| ApoCIII, mean (SD), mg/dL | 11.3 (3.0) | 10.4 (3.3) | 9.5 (3.2) | 10.4 (3.2) |
| Lp(a), median (IQR), nmol/L | 31.0 (16.0-154.0) | 22.5 (18.0-66.0) | 35.0 (15.0-157.0) | 29.0 (16.5-120.0) |
| Any CV history/risk factors, No. (%) | 29 (93.5) | 28 (87.5) | 30 (90.9) | 87 (90.6) |
| CHD | 24 (77.4) | 17 (53.1) | 19 (57.6) | 60 (62.5) |
| Acute MI | 13 (41.9) | 8 (25.0) | 13 (39.4) | 34 (35.4%) |
| Silent MI | 0 | 0 | 0 | 0 |
| Angina (chronic stable/unstable) | 16 (51.6) | 13 (40.6) | 13 (39.4) | 42 (43.8) |
| Coronary revascularization procedure | 19 (61.3) | 12 (37.5) | 17 (51.5) | 48 (50.0) |
| CHD risk equivalents | 7 (22.6) | 5 (15.6) | 8 (24.2) | 20 (20.8) |
| Peripheral arterial disease | 1 (3.2) | 3 (9.4) | 6 (18.2) | 10 (10.4) |
| Ischemic stroke | 2 (6.5) | 1 (3.1) | 2 (6.1) | 5 (5.2) |
| Chronic kidney disease | 1 (3.2) | 0 | 0 | 1 (1.0) |
| Known history of diabetes (type 1 or 2) and 2 or more additional risk factorsd | 4 (12.9) | 2 (6.3) | 2 (6.1) | 8 (8.3) |
| Categorization of CV risk factors, No. (%)e | ||||
| Very high CV risk | 26 (83.9) | 19 (59.4) | 21 (63.6) | 66 (68.8) |
| High CV risk | 5 (16.1) | 13 (40.6) | 12 (36.4) | 30 (31.3) |
| LLTs, No. (%) | ||||
| Any statin | 26 (83.9) | 25 (78.1) | 30 (90.9) | 81 (84.4) |
| High-intensity statinf | 14 (45.2) | 17 (53.1) | 20 (60.6) | 51 (53.1) |
| Ezetimibe | 11 (35.5) | 14 (43.8) | 11 (33.3) | 36 (37.5) |
| PCSK9 inhibitor | 30 (96.8) | 30 (93.8) | 32 (97.0) | 92 (95.8) |
Abbreviations: Apo, apolipoprotein; BMI, body mass index; CHD, coronary heart disease (including acute or stable MI, chronic stable or unstable angina, or coronary revascularization); CV, cardiovascular; FH, familial hypercholesterolemia; HeFH, heterozygous familial hypercholesterolemia; HDL-C, high-density lipoprotein cholesterol; IV, intravenous; LDL-C, low-density lipoprotein cholesterol; Lp(a), lipoprotein(a); LLT, lipid-lowering therapy; MI, myocardial infarction; PCSK9, proprotein convertase subtilisin/kexin type 9; Q4W, every 4 weeks.
SI conversion factor: To convert ApoA1 to grams per liter, multiply by 0.01; to convert ApoB to grams per liter, multiply by 0.01; to convert HDL-C to millimoles per liter, multiply by 0.0259; to convert LDL-C to millimoles per liter, multiply by 0.0259; to convert total cholesterol to millimoles per liter, multiply by 0.0259.
Race and ethnicity were determined based on self-report to the treating physician.
Patients were categorized as other if they did not self-report as African American or Black, American Indian or Alaska Native, Asian, Native Hawaiian or Other Pacific Islander, or White.
Calculated as weight in kilograms divided by height in meters squared.
Risk factors include history of ankle-brachial index 0.9 or less, hypertension, microalbuminuria or macroalbuminuria, proliferative diabetic retinopathy, and known family history of CHD.
Patients with very-high CV risk were defined as patients with CHD or CHD risk equivalents. Patients with high CV risk were defined as patients without very-high CV risk. To note, the definition of very-high CV risk in this study differs from the 2022 American College of Cardiology expert consensus decision pathway on the role of nonstatin therapies for LDL-C lowering in the management of ASCVD risk, which defines patients with very-high risk as those with a history of multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions.9
High-intensity statin defined as rosuvastatin, 20 mg or 40 mg, daily or atorvastatin, 40 mg or 80 mg, daily.