Table 1.
Baseline characteristics (randomized population)
| Alirocumab 75/150 mg every 2 weeksn = 276 | UC n = 137 | |
|---|---|---|
| Age, years | 62.8 (9.3) | 64.1 (8.8) |
| Men | 147 (53.3) | 69 (50.4) |
| Race | ||
| White | 247 (89.5) | 123 (89.8) |
| Black | 16 (5.8) | 6 (4.4) |
| Ethnicity: Hispanic/Latin | 35 (12.7) | 14 (10.2) |
| Body mass index, kg/m2 | 32.7 (5.4) | 33.2 (4.9) |
| HbA1c, % [mmol/mol] | 7.1 (0.8) [53.5 (9.1)] | 7.1 (0.9) [54.5 (9.4)] |
| HbA1c | ||
| <7% (<53.0 mmol/mol) | 134 (48.6) | 57 (41.6) |
| ≥7% to <8% (≥53.0 mmol/mol to <63.9 mmol/mol) | 100 (36.2) | 56 (40.9) |
| ≥8% to <9 (≥63.9 mmol/mol to <74.9 mmol/mol) | 42 (15.2) | 24 (17.5) |
| FPG | ||
| mmol/L | 8.04 (2.11) | 8.22 (2.19) |
| mg/dL | 144.9 (38.1) | 148.1 (39.4) |
| Median (Q1:Q3) duration of DM, years | 10.7 (5.5:17.5) | 11.5 (6.2:18.7) |
| Hypertensiona | 241 (87.3) | 123 (89.8) |
| Current cigarette smoker | 38 (13.8) | 23 (16.8) |
| CKDb | 41 (14.9) | 23 (16.8) |
| Individuals with ASCVD | 95 (34.4) | 47 (34.3) |
| Individuals without ASCVD but with additional CV risk factor | 181 (65.6) | 90 (65.7) |
| Any statinc | 231 (84.0) | 105 (76.6) |
| High‐intensity statind | 107 (46.3) | 38 (36.2) |
| Moderate‐intensity statind | 103 (44.6) | 64 (61.0) |
| Low‐intensity statind | 21 (9.1) | 3 (2.9) |
| Any LLT other than statinse before randomization | 1 (0.4) | 2 (1.5) |
| Fenofibrates | 1 (0.4) | 1 (0.7) |
| Cholesterol absorption inhibitor | 0 | 1 (0.7) |
| Nutraceuticals impacting lipids/other | 0 | 1 (0.7) |
| No LLTc (no statin or other LLT) | 44 (16.0) | 32 (23.4) |
| Statin‐intolerant | 43 (15.6) | 31 (22.6) |
| Concomitant antihyperglycemic drugsc | ||
| Biguanides | 211 (76.7) | 106 (77.4) |
| Insulin | 102 (37.1) | 56 (40.9) |
| Sulphonylureas | 67 (24.4) | 31 (22.6) |
| SGLT2 inhibitors | 39 (14.2) | 18 (13.1) |
| DPP‐4 inhibitors | 36 (13.1) | 20 (14.6) |
| GLP‐1RA | 32 (11.6) | 21 (15.3) |
| Thiazolidinediones | 9 (3.3) | 5 (3.6) |
| α‐glucosidase inhibitors | 2 (0.7) | 2 (1.5) |
| Other blood glucose‐lowering drugs | 9 (3.3) | 2 (1.5) |
| Baseline lipidsf | ||
| Non‐HDL cholesterol | ||
| mmol/L | 4.02 (1.20) | 4.18 (1.26) |
| mg/dL | 155.1 (46.2) | 161.5 (48.8) |
| LDL cholesterol, measuredg | ||
| mmol/L | 2.86 (1.04) | 3.04 (1.13) |
| mg/dL | 110.4 (40.3) | 117.3 (43.5) |
| ApoB, mg/dL [g/L] | 101.9 (25.8) [1.0 (0.3)] | 106.1 (28.7) [1.1 (0.3)] |
| Total cholesterol | ||
| mmol/L | 5.06 (1.19) | 5.25 (1.32) |
| mg/dL | 195.4 (46.0) | 202.5 (51.1) |
| Median (Q1:Q3) Lp(a), mg/dL | 16.0 (5.0:54.0) | 15.0 (5.0:40.0) |
| Median (Q1:Q3) TGs | ||
| mmol/L | 2.43 (1.91:3.22) | 2.40 (1.90:3.12) |
| mg/dL | 214.5 (169.0:285.0) | 212.0 (168.0:276.0) |
| HDL cholesterol | ||
| mmol/L | 1.04 (0.25) | 1.06 (0.30) |
| mg/dL | 40.3 (9.8) | 41.1 (11.6) |
| LDL particle number, nmol/L | 1404.1 (456.1) | 1483.8 (482.8) |
| ApoA1, mg/dL | 138.6 (21.2) | 139.4 (22.9) |
| LDL particle size, nm | 20.3 (0.6) | 20.3 (0.6) |
Abbreviations: Alirocumab 75/150 mg Q2W, alirocumab 75 mg Q2W with possible dose increase to 150 mg Q2W at Week 12; Apo, apolipoprotein; ASCVD, atherosclerotic cardiovascular disease; CKD, chronic kidney disease; CV, cardiovascular; DM, diabetes mellitus; DPP‐4, dipeptidyl peptidase 4; FPG, fasting plasma glucose; eGFR, estimated glomerular filtration rate; GLP‐1RA, glucagon‐like peptide 1 receptor agonist; HbA1c, glycated haemoglobin; LLT, lipid‐lowering therapy; Lp(a), lipoprotein a; Q1/Q3, first/third quartile; SGLT2, sodium‐glucose co‐transporter‐2; TG, triglyceride; UC, usual care.
Data are mean (SD) or n (%), unless otherwise indicated.
Established based on use of antihypertensive medication.
Defined as eGFR 15–60 mL/min/1.73 m2.
Data presented for safety population (275 alirocumab; 137 UC).
High‐intensity statin: atorvastatin 40 to 80 mg, rosuvastatin 20 to 40 mg or simvastatin 80 mg. Moderate‐intensity statin: atorvastatin 10 to 20 mg, fluvastatin 40 mg, fluvastatin extended release 80 mg, lovastatin 40 mg, pitavastatin 2 to 4 mg, pravastatin 10 to 20 mg, rosuvastatin 5 to 10 mg or simvastatin 20 to 40 mg. Low‐intensity statin: fluvastatin 20 to 40 mg, lovastatin 20 mg, pitavastatin 1 mg, pravastatin 10 to 20 mg or simvastatin 10 mg.
In combination with statins or not.
Order based on hierarchical order, except for LDL particle size.
β‐quantification.