Table 1.
Baseline demographics (ITT population)
| Alirocumab (n = 128) | Usual carea (n = 58) | |
|---|---|---|
| Age, years, mean (SD) | 62.1 (9.5) | 63.4 (9.0) |
| Male, n (%) | 65 (50.8) | 28 (48.3) |
| Race, n (%) | ||
| American Indian or Alaska Native | 3 (2.3) | 0 |
| Asian/Oriental | 2 (1.6) | 6 (10.3) |
| Black | 4 (3.1) | 2 (3.4) |
| Other | 3 (2.3) | 0 |
| White/Caucasian | 116 (90.6) | 50 (86.2) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 17 (13.3) | 8 (13.8) |
| Not Hispanic or Latino | 110 (85.9) | 50 (86.2) |
| Not reported/unknown | 1 (0.8) | 0 |
| Weight, kg, mean (SD) | 93.6 (19.7) | 93.8 (16.4) |
| BMI, kg/m2, mean (SD) | 32.6 (4.9) | 33.0 (4.6) |
| Systolic blood pressure, mmHg, mean (SD) | 130.0 (14.4) | 134.9 (15.7) |
| Diastolic blood pressure, mmHg, mean (SD) | 76.3 (9.8) | 77.2 (9.2) |
| ASCVD (CHD, ischemic stroke, PAD), n (%) | 47 (36.7) | 24 (41.4) |
| HbA1c, %, mean (SD) | 7.0 (0.9) | 7.3 (0.8) |
| Fasting plasma glucose, mg/dL, mean (SD) | 150.2 (39.2) | 153.2 (41.1) |
| Individuals receiving insulin at baseline, n (%) | 52 (40.6) | 26 (44.8) |
| Baseline lipids, mean (SD) | ||
| Non-HDL-C, mg/dL | 170.3 (48.2) | 166.3 (48.8) |
| mmol/L | 4.41 (1.25) | 4.31 (1.26) |
| LDL-C (beta-quantification), mg/dL | 112.8 (43.7) | 110.7 (42.1) |
| mmol/L | 2.92 (1.13) | 2.87 (1.09) |
| ApoB, mg/dL | 109.3 (27.4) | 108.1 (28.9) |
| LDL particle number, nmol/L | 1497.3 (532.0) | 1491.5 (545.1) |
| Lipoprotein(a), mg/dL, median (Q1:Q3) | 18.0 (5.0:55.0) | 9.5 (4.0:30.0) |
| TGs, mg/dL, median (Q1:Q3) | 281.5 (245.0:369.0) | 269.0 (232.0:328.0) |
| mmol/L | 3.19 (2.77:4.17) | 3.04 (2.62:3.71) |
| HDL-C, mg/dL | 34.4 (6.2) | 34.3 (5.9) |
| mmol/L | 0.89 (0.16) | 0.89 (0.15) |
ASCVD atherosclerotic cardiovascular disease, ApoB apolipoprotein B, BMI body mass index, CHD coronary heart disease, HbA1c glycated hemoglobin, HDL-C high-density lipoprotein cholesterol, ITT intention-to-treat, LDL low-density lipoprotein, LDL-C low-density lipoprotein cholesterol, PAD peripheral artery disease, SD standard deviation, TG triglyceride
aOptions included ezetimibe, fenofibrate, no additional lipid-lowering therapy, omega-3 fatty acid, and nicotinic acid