Table 1.
Baseline characteristics and lipid levels, pooled by comparator and prediabetes status (randomized population)
| Placebo‐controlled pool | Ezetimibe‐controlled pool | |||||||
|---|---|---|---|---|---|---|---|---|
| Prediabetes (N = 1285) | Normoglycaemia (N = 1084) | Prediabetes (N = 575) | Normoglycaemia (N = 397) | |||||
| Alirocumab (N = 865) | Placebo (N = 420) | Alirocumab (N = 718) | Placebo (N = 366) | Alirocumab (N = 332) | Ezetimibe (N = 243) | Alirocumab (N = 223) | Ezetimibe (N = 174) | |
| Mean (sd) age, years | 59.8 (10.4) | 60.5 (10.2) | 54.1 (13.4) | 54.7 (12.8) | 62.0 (8.8) | 62.6 (9.3) | 60.5 (9.7) | 59.9 (10.8) |
| Men, n (%) | 551 (63.7) | 276 (65.7) | 435 (60.6) | 225 (61.5) | 241 (72.6) | 165 (67.9) | 145 (65.0) | 101 (58.0) |
| Mean (sd) BMI, kg/m2 | 29.9 (5.1) | 29.6 (5.1) | 28.0 (4.7) | 28.6 (4.8) | 29.9 (5.1) | 29.6 (5.4) | 27.7 (4.7) | 27.6 (4.1) |
| Mean (sd) HbA1c | ||||||||
| mmol/mol | 40 (3) | 40 (3) | 35 (2) | 35 (2) | 40 (3) | 40 (3) | 35 (2) | 35 (3) |
| % | 5.8 (0.3) | 5.8 (0.3) | 5.3 (0.2) | 5.4 (0.2) | 5.8 (0.3) | 5.8 (0.3) | 5.4 (0.2) | 5.4 (0.2) |
| Mean (sd) FPG | ||||||||
| mmol/l | 5.7 (0.6) | 5.7 (0.6) | 5.1 (0.5) | 5.1 (0.5) | 5.8 (0.8) | 5.7 (0.7) | 5.2 (0.5) | 5.1 (0.5) |
| mg/dl | 102.1 (11.4) | 102.1 (11.5) | 92.5 (9.5) | 92.3 (9.7) | 105.3 (14.5) | 102.8 (12.7) | 94.2 (9.2) | 92.6 (8.3) |
| Hypertension, n (%) | 547 (63.2) | 276 (65.7) | 351 (48.9) | 193 (52.7) | 246 (74.1) | 166 (68.3) | 127 (57.0) | 98 (56.3) |
| HeFH, n (%) | 346 (40.0) | 153 (36.4) | 393 (54.7) | 200 (54.6) | 8 (2.4) | 19 (7.8) | 27 (12.1) | 22 (12.6) |
| ASCVDa, n (%) | 676 (78.2) | 347 (82.6) | 459 (63.9) | 233 (63.7) | 269 (81.0) | 178 (73.3) | 160 (71.7) | 100 (57.5) |
| Any statin, n (%) | 865 (100.0) | 419 (99.8) | 717 (99.9) | 366 (100.0) | 268 (80.7) | 175 (72.0) | 152 (68.2) | 100 (57.5) |
|
High‐dose statinb, n (%) |
540 (62.4) | 261 (62.1) | 451 (62.8) | 244 (66.7) | 184 (55.4) | 116 (47.7) | 95 (42.6) | 57 (32.8) |
| Any other LLTs, n (%) | 338 (39.1) | 177 (42.1) | 318 (44.3) | 168 (45.9) | 34 (10.2) | 37 (15.2) | 43 (19.3) | 46 (26.4) |
| Baseline lipid levels, mean (sd) unless otherwise specified | ||||||||
| LDL cholesterol | ||||||||
| mmol/l | 3.3 (1.2) | 3.2 (1.1) | 3.5 (1.3) | 3.6 (1.3) | 3.1 (1.2) | 3.3 (1.5) | 3.6 (1.7) | 3.6 (1.7) |
| mg/dl | 126.9 (46.1) | 123.1 (40.7) | 136.8 (51.8) | 138.6 (50.8) | 119.6 (46.5) | 127.3 (57.3) | 140.8 (67.1) | 140.7 (65.8) |
| HDL cholesterol | ||||||||
| mmol/l | 1.3 (0.3) | 1.3 (0.3) | 1.4 (0.4) | 1.3 (0.4) | 1.3 (0.3) | 1.3 (0.4) | 1.4 (0.4) | 1.4 (0.4) |
| mg/dl | 50.0 (13.1) | 50.6 (12.9) | 52.7 (14.6) | 50.9 (13.6) | 48.8 (13.5) | 50.0 (14.1) | 53.4 (15.0) | 53.1 (15.3) |
| Fasting triglycerides, median (Q1:Q3) | ||||||||
| mmol/l | 1.4 (1.0: 2.0) | 1.4 (1.1: 2.0) | 1.2 (0.9: 1.7) | 1.2 (0.9: 1.8) | 1.5 (1.1: 2.2) | 1.5 (1.1: 2.2) | 1.3 (0.9: 1.8) | 1.3 (0.9: 2.0) |
| mg/dl | 126.5 (92.0: 176.0) | 126.5 (94.0: 173.0) | 106.6 (79.0: 149.0) | 109.7 (80.0: 162.0) | 135.0 (98.0: 191.5) | 135.0 (100.0: 197.0) | 114.0 (82.0: 161.0) | 112.0 (83.0: 178.0) |
| Non‐HDL cholesterol | ||||||||
| mmol/l | 4.0 (1.3) | 3.9 (1.1) | 4.2 (1.4) | 4.3 (1.4) | 3.9 (1.3) | 4.2 (1.8) | 4.4 (1.9) | 4.3 (1.8) |
| mg/dl | 155.4 (49.8) | 151.6 (44.1) | 161.4 (54.7) | 164.2 (54.3) | 150.4 (49.8) | 160.1 (69.9) | 168.0 (74.9) | 167.7 (68.1) |
| Apo B, mg/dl | 104.1 (28.9) | 102.0 (26.0) | 106.9 (31.1) | 109.3 (31.3) | 99.4 (28.2) | 102.8 (33.2) | 106.6 (36.9) | 108.9 (35.6) |
| Median (Q1:Q3) Lp(a), mg/dl | 29.0 (10.0: 75.0) | 25.0 (8.1: 71.3) | 24.5 (10.0: 70.6) | 24.4 (7.0: 77.5) | 25.0 (8.0: 75.0) | 24.0 (8.0: 59.0) | 24.0 (7.0: 64.0) | 22.0 (9.0: 55.0) |
Apo, apolipoprotein; ASCVD, atherosclerotic cardiovascular disease; FPG, fasting plasma glucose; HeFH, heterozygous familial hypercholesterolaemia; LLT, lipid‐lowering therapy; Lp(a) lipoprotein(a).
a
ASCVD included coronary heart disease, peripheral arterial disease and ischaemic stroke; for the FH II, ALTERNATIVE, OPTIONS I and OPTIONS II studies; transient ischaemic attack, carotid endarterectomy or carotid artery stent procedure, and renal artery stent procedure were also included.
b
High‐dose statin was defined as atorvastatin ≥ 40 mg, rosuvastatin ≥ 20 mg or simvastatin ≥ 80 mg.