Table 1.
Patient demographic and disease characteristics at baseline
| Characteristic | High TGs and normal HDL-C | High TGs and low HDL-C | Normal TGs and normal HDL-C | |||
|---|---|---|---|---|---|---|
| Placebo N = 64 | Evolocumab N = 132 | Placebo N = 125 | Evolocumab N = 264 | Placebo N = 178 | Evolocumab N = 341 | |
| Sex, female, n (%) | 28 (43.8) | 58 (43.9) | 72 (57.6) | 143 (54.2) | 95 (53.4) | 161 (47.2) |
| Age, years, mean (SD) | 63.0 (8.6) | 61.9 (8.6) | 60.2 (8.2) | 60.9 (8.5) | 62.6 (8.8) | 62.2 (8.1) |
| Ethnicity Hispanic/Latino, n (%) | 12 (18.8) | 28 (21.2) | 29 (23.2) | 60 (22.7) | 23 (12.9) | 55 (16.1) |
| Race, n (%) | ||||||
| White | 40 (62.5) | 82 (62.1) | 79 (63.2) | 165 (62.5) | 83 (46.6) | 157 (46.0) |
| Asian | 15 (23.4) | 40 (30.3) | 32 (25.6) | 73 (27.7) | 72 (40.4) | 144 (42.2) |
| Black or African American | 7 (10.9) | 8 (6.1) | 6 (4.8) | 11 (4.2) | 20 (11.2) | 31 (9.1) |
| American Indian or Alaska native | 1 (1.6) | 1 (0.8) | 6 (4.8) | 6 (2.3) | 0 (0.0) | 2 (0.6) |
| Native Hawaiian or other Pacific Islander | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.4) | 0 (0.0) | 0 (0.0) |
| Multiple | 1 (1.6) | 1 (0.8) | 2 (1.6) | 7 (2.7) | 3 (1.7) | 6 (1.8) |
| Other | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.4) | 0 (0.0) | 1 (0.3) |
| BMI, kg/m2, mean (SD) | 31.2 (7.4) | 30.2 (6.0) | 31.2 (6.6) | 31.6 (6.3) | 28.8 (6.2) | 28.4 (5.2) |
| Waist circumference, cm, mean (SD) | 103.9 (17.2) | 103.2 (14.4) | 104.1 (16.6) | 104.2 (15.7) | 96.8 (14.4) | 97.3 (12.8) |
| Duration of diabetes, years, mean (SD) | 9.6 (7.51) | 10.6 (7.80) | 9.9 (7.52) | 10.5 (7.18) | 10.1 (7.75) | 10.2 (7.60) |
| Fasting serum glucose, mmol/L, median (Q1, Q3) | 7.25 (6.00, 8.85) | 7.30 (6.20, 9.50) | 7.50 (6.20, 9.70) | 8.15 (6.35, 10.50) | 6.80 (5.80, 8.30) | 7.00 (5.80, 8.70) |
| HbA1c (fraction of 1), median (Q1, Q3) |
0.0690 (0.0640, 0.0755) |
0.0700 (0.0645, 0.0815) | 0.0740 (0.0640, 0.0860) | 0.0740 (0.0655, 0.0840) | 0.0670 (0.0620, 0.0760) | 0.0700 (0.0630, 0.0800) |
| Cardiovascular risk category per 2019 ESC/EAS [5] guidelines, n (%) | ||||||
| Very high risk | 58 (90.6) | 124 (93.9) | 116 (92.8) | 243 (92.0) | 154 (86.5) | 303 (88.9) |
| High risk | 6 (9.4) | 8 (6.1) | 9 (7.2) | 21 (8.0) | 24 (13.5) | 38 (11.1) |
| Statin use per 2018 ACC/AHA guidelines [21], n (%) | ||||||
| Any statin usea | 48 (75.0) | 104 (78.8) | 95 (76.0) | 213 (80.7) | 120 (67.4) | 216 (63.3) |
| High-intensity statin | 12 (18.8) | 29 (22.0) | 35 (28.0) | 67 (25.4) | 23 (12.9) | 45 (13.2) |
| Moderate-intensity statin | 35 (54.7) | 71 (53.8) | 56 (44.8) | 134 (50.8) | 93 (52.2) | 162 (47.5) |
| Ezetimibe | 1 (1.6) | 4 (3.0) | 4 (3.2) | 7 (2.7) | 5 (2.8) | 9 (2.6) |
| Lipid concentration | ||||||
| LDL-C, mmol/L, mean (SD) | 2.811 (0.901) | 2.737 (0.971) | 2.508 (0.817) | 2.599 (0.895) | 2.539 (0.884) | 2.511 (0.818) |
| Non-HDL-C, mmol/L, mean (SD) | 3.819 (0.977) | 3.752 (1.004) | 3.720 (0.933) | 3.793 (0.985) | 3.052 (0.926) | 3.033 (0.849) |
| Total ApoB, g/L, mean (SD) | 0.986 (0.225) | 0.974 (0.229) | 0.983 (0.238) | 0.996 (0.239) | 0.825 (0.217) | 0.827 (0.205) |
| Lp(a), nmol/L, median (Q1, Q3) |
21.0 7.0, 58.0 |
37.0 9.0, 128.8 |
29.0 8.0, 136.0 |
22.0 8.0, 76.0 |
47.0 12.0, 128.0 |
33.0 11.5, 121.0 |
| VLDL-C, mmol/L, median (Q1, Q3) |
0.970 (0.830, 1.140) |
0.953 (0.840, 1.110) |
1.040 (0.880, 1.335) |
1.090 (0.910, 1.370) |
0.520 (0.410, 0.600) |
0.520 (0.410, 0.645) |
| Remnant cholesterol, mmol/L, median (Q1, Q3) |
0.965 (0.830, 1.125) |
0.953 (0.840, 1.120) |
1.060 (0.875, 1.400) |
1.100 (0.900, 1.370) |
0.520 (0.420, 0.600) |
0.520 (0.420, 0.640) |
| TG, mmol/L, median (Q1, Q3) |
2.133 1.815, 2.475 |
2.078 1.830, 2.445 |
2.300 1.940, 3.065 |
2.440 1.975, 3.038 |
1.115 0.915, 1.300 |
1.140 0.900, 1.390 |
| HDL-C, mmol/L, mean (SD) | 1.353 (0.245) | 1.343 (0.206) | 0.947 (0.163) | 0.935 (0.185) | 1.488 (0.338) | 1.440 (0.286) |
When the calculated LDL-C was < 1.0 mmol/L or TGs were > 4.5 mmol/L, calculated LDL-C was replaced with ultracentrifugation to inform LDL-C and VLDL-C from the same blood sample, if available
ACC American College of Cardiology, AHA American Heart Association, ApoB apolipoprotein B, BMI body mass index, EAS European Atherosclerosis Society, ESC European Society of Cardiology, HbA1c hemoglobin A1c, HDL-C high-density lipoprotein cholesterol, LDL-C low-density lipoprotein cholesterol, Lp(a) lipoprotein(a), non-HDL-C non-high-density lipoprotein cholesterol, Q quartile, TG triglycerides, VLDL-C very low-density lipoprotein cholesterol
aRepresents use of statin therapy before initiating any treatment intervention (including atorvastatin and/or study drug); in BANTING, 99.3% of patients were on moderate- or high-intensity statin at randomization; in BERSON, all patients initiated moderate-intensity atorvastatin at enrollment