Table 1.
Demographic and Baseline Characteristics
| 450 mg Q4W |
Overall (N = 303) | ||
|---|---|---|---|
| Tafolecimab (n = 205) | Placebo (n = 98) | ||
| Age, y | 56.9 ± 9.2 | 56.8 ± 9.4 | 56.8 ± 9.2 |
| Asian | 205 (100) | 98 (100) | 303 (100) |
| Male | 147 (71.7) | 62 (63.3) | 209 (69.0) |
| BMI, kg/m2 | 26.6 ± 4.0 | 26.3 ± 3.7 | 26.5 ± 3.9 |
| Screening LDL-Ca | |||
| <3.4 mmol/L | 158 (77.1) | 76 (77.6) | 234 (77.2) |
| ≥3.4 mmol/L | 47 (22.9) | 22 (22.4) | 69 (22.8) |
| FH classificationb | |||
| HeFH | 25 (12.2) | 13 (13.3) | 38 (12.5) |
| Non-FH | 180 (87.8) | 85 (86.7) | 265 (87.5) |
| Cardiovascular riskc | |||
| High risk | 54 (26.3) | 23 (23.5) | 77 (25.4) |
| Very high risk | 150 (73.2) | 75 (76.5) | 225 (74.3) |
| Missingd | 1 (0.5) | 0 | 1 (0.3) |
| Concomitant disease | |||
| Cardiovascular disease | 105 (51.2) | 52 (53.1) | 157 (51.8) |
| Cerebrovascular disease | 44 (21.5) | 16 (16.3) | 60 (19.8) |
| Type 2 diabetes | 68 (33.2) | 36 (36.7) | 104 (34.3) |
| Chronic kidney disease | 70 (34.1) | 31 (31.6) | 101 (33.3) |
| Mixed dyslipidemia | 113 (55.1) | 57 (58.2) | 170 (56.1) |
| Lipid-regulating medication | |||
| Moderate-dose statin | 198 (96.6) | 97 (99.0) | 295 (97.4) |
| High-dose statine | 7 (3.4) | 1 (1.0) | 8 (2.6) |
| Ezetimibe | 23 (11.2) | 8 (8.2) | 31 (10.2) |
| Lipid parameters | |||
| LDL-C, mmol/L | 3.05 ± 0.95 | 3.10 ± 0.78 | 3.06 ± 0.90 |
| Apolipoprotein B, g/L | 0.90 ± 0.25 | 0.88 ± 0.22 | 0.89 ± 0.24 |
| Apolipoprotein B/apolipoprotein A1 | 0.64 ± 0.23 | 0.63 ± 0.18 | 0.63 ± 0.21 |
| Lipoprotein(a), g/L | 0.15 (0.08-0.33) | 0.16 (0.08-0.34) | 0.16 (0.08-0.34) |
| Non-HDL-C, mmol/L | 3.49 ± 1.10 | 3.52 ± 0.93 | 3.50 ± 1.05 |
Values are mean ± SD, median (IQR), or n (%).
BMI = body mass index; CV = cardiovascular; HDL-C = high-density lipoprotein cholesterol; FH = familial hypercholesterolemia; HeFH = heterozygous familial hypercholesterolemia; LDL-C = low-density lipoprotein cholesterol; PI = principal investigator; PPS = per protocol set; Q4W = every 4 weeks.
Randomization stratification factors.
By Simon Broome diagnostic criteria.
Refer to ESC guideline for criteria for high/very high CV risk.
After the patient successfully quit smoking, the patient was no longer characterized to have a high CV risk, and after discussion with the lead PI, the patient was included in the PPS.
Defined as atorvastatin 40-80 mg or rosuvastatin 20 mg.