Table 2.
Baseline Characteristics (Randomized Population)
| Alirocumab (n = 96) | Placebo (n = 50) | |
|---|---|---|
| Age, mean (SD), y | 62.8 (9.0) | 62.6 (9.0) |
| Sex, male, n (%) | 60 (62.5) | 34 (68.0) |
| BMI, mean (SD), kg/m2 | 33.6 (6.9) | 34.5 (6.4) |
| Race, white, n (%) | 78 (81.3) | 38 (76.0) |
| ASCVD, n (%) | 58 (60.4) | 29 (58.0) |
| Hypertension, n (%) | 85 (88.5) | 44 (88.0) |
| CKD, n (%) | 5 (5.2) | 5 (10.0) |
| Mild CKD/normal renal functiona | 1 (1.0) | 0 |
| Moderate CKDa | 4 (4.2) | 5 (10.0) |
| FPG, mean (SD), mg/dL | 127.0 (39.3) | 136.4 (46.9) |
| HbA1c, mean (SD), % | 6.9 (0.9) | 6.9 (0.8) |
| eGFR, mean (SD), mL/min/1.73m2 | 74.9 (19.5) | 74.8 (21.4) |
| Diastolic blood pressure, mean (SD), mmHg | 78.4 (8.5) | 77.6 (9.5) |
| Systolic blood pressure, mean (SD), mmHg | 131.1 (12.2) | 132.5 (13.6) |
| Individuals receiving glucose-lowering therapy, n (%) | 72 (75.0) | 44 (88.0) |
| Individuals receiving insulin, n (%) | 26 (27.1) | 14 (28.0) |
| Individuals receiving no glucose-lowering therapy, n (%) | 24 (25.0) | 6 (12.0) |
| LLT other than statins,b n (%) | ||
| Ezetimibe | 12 (12.5) | 5 (10.0) |
| Nutraceuticals | 12 (12.5) | 6 (12.0) |
| Omega-3 fatty acids | 10 (10.4) | 5 (10.0) |
| Fibrates | 8 (8.3) | 3 (6.0) |
| Nicotinic acid and derivatives | 3 (3.1) | 1 (2.0) |
| Lipids, mean (SD), mg/dL | ||
| Non–HDL-C | 139.2 (33.4) | 136.0 (40.7) |
| LDL-C, calculated | 106.8 (29.4) | 106.5 (35.7) |
| HDL-C | 46.2 (11.6) | 44.9 (11.2) |
| TGs, median (Q1:Q3) | 150.0 (106.5:196.0) | 128.0 (103.0:185.0) |
| Lp(a), median (Q1:Q3) | 20.0 (6.0:56.0) | 20.5 (7.0:58.5) |
| ApoB | 96.9 (20.9) | 93.4 (24.7) |
| ApoA1 | 146.0 (23.6) | 137.1 (26.0) |
| TRL-C, median (Q1:Q3) | 30.0 (21.5:39.0) | 26.0 (21.0:37.0) |
Abbreviations: ASCVD, atherosclerotic cardiovascular disease; BMI, body mass index; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; Q, quartile.
a
Mild CKD/normal renal function defined as eGFR 60–89/≥90 mL/min/1.73m2; moderate CKD defined as eGFR 30–59 mL/min/1.73m2.
b
Individuals could be receiving more than one LLT.