Table 1. Baseline Demographic, Clinical, and Treatment Characteristics.
| Ezetimibe | Evolocumab | All | |
|---|---|---|---|
| (N = 21) | (N = 40) | (N = 61) | |
| Age, mean (SD), y | 61.8 (11.9) | 65.8 (9.8) | 64.4 (10.6) |
| Female sex, n (%) | 10 (47.6) | 21 (52.5) | 31 (50.8) |
| Screening LDL-C level,§ n (%) | |||
| < 180 mg/dL | 11 (52.4) | 19 (47.5) | 30 (49.2) |
| ≥ 180 mg/dL | 10 (47.6) | 21 (52.5) | 31 (50.8) |
| Statin use,§ n (%) | 6 (28.6) | 8 (20.0) | 14 (23.0) |
| LDL-C, mean (SD), mg/dL | 181.9 (56.1) | 192.8 (53.0) | 189.0 (53.9) |
| Triglycerides, mean (SD), mg/dL | 161.7 (95.9) | 149.6 (59.8) | 153.8 (73.7) |
| Non-HDL-C, mean (SD), mg/dL | 214.1 (56.3) | 222.7 (52.8) | 219.8 (53.7) |
| HDL-C, mean (SD), mg/dL | 63.4 (15.5) | 59.4 (20.1) | 60.8 (18.6) |
| Total cholesterol, mean (SD), mg/dL | 277.5 (61.0) | 282.2 (56.1) | 280.5 (57.3) |
| ApoB, mean (SD), mg/dL | 126.8 (25.0) | 139.5 (28.6) | 135.1 (27.9) |
| ApoA1, mean (SD), mg/dL | 163.9 (24.6) | 156.6 (33.0) | 159.1 (30.3) |
| Lp(a), median (Q1, Q3), nmol/L | 28.0 (19.0, 52.0) | 37.0 (16.5, 79.0) | 30.0 (17.0, 71.0) |
| hsCRP, mean (SD), mg/dL | 0.8 (1.1) | 2.0 (3.6) | 1.6 (3.0) |
| Cardiovascular risk factors, n (%) | |||
| NCEP high risk | 10 (47.6) | 25 (62.5) | 35 (57.4) |
| CAD | 7 (33.3) | 17 (42.5) | 24 (39.3) |
| Cerebrovascular or peripheral artery disease | 1 (4.8) | 10 (25.0) | 11 (18.0) |
| Current cigarette smoking | 1 (4.8) | 3 (7.5) | 4 (6.6) |
| Type 2 diabetes mellitus | 4 (19.0) | 7 (17.5) | 11 (18.0) |
| Hypertension | 12 (57.1) | 23 (57.5) | 35 (57.4) |
| ≥ 2 cardiovascular risk factors | 7 (33.3) | 13 (32.5) | 20 (32.8) |
| Metabolic syndrome without diabetes mellitus | 7 (33.3) | 14 (35.0) | 21 (34.4) |
| Intolerance to statins (number of statins per patient), n (%) | |||
| 1 | 1 (4.8) | 1 (2.5) | 2 (3.3) |
| 2 | 17 (81.0) | 28 (70.0) | 45 (73.8) |
| 3 | 3 (14.3) | 7 (17.5) | 10 (16.4) |
| ≥ 4 | 0 | 4 (10.0) | 4 (6.6) |
| Worst muscle-related side effect for any statin, n (%) | |||
| Myalgia | 12 (57.1) | 25 (62.5) | 37 (60.7) |
| Myositis | 7 (33.3) | 14 (35.0) | 21 (34.4) |
| Rhabdomyolysis | 2 (9.5) | 1 (2.5) | 3 (4.9) |
To convert LDL-C, HDL-C, total cholesterol, and non-HDL-C values from mg/dL to mmol/L, multiply by 0.0259; triglycerides values from mg/dL to mmol/L, multiply by 0.0113; and hsCRP values from mg/L to nmol/L, multiply by 9.524. When the calculated LDL-C was < 40 mg/dL or triglycerides were > 400 mg/dL, calculated LDL-C was replaced with ultracentrifugation LDL-C from the same blood sample, if available.
§
Randomization stratification factor
Abbreviations: ApoA1, apolipoprotein A1; ApoB, apolipoprotein B; CAD, coronary artery disease; HDL-C, high-density lipoprotein-cholesterol; hsCRP, high-sensitivity C-reactive protein; LDL-C, low-density lipoprotein-cholesterol; Lp(a), lipoprotein(a); NCEP, National Cholesterol Education Program.