Table 1.
Baseline characteristics (randomized population)
| DM-DYSLIPIDEMIA | DM-INSULIN | |||
|---|---|---|---|---|
| Alirocumab (n = 95) | UC (n = 47) | Alirocumab (n = 119) | Placebo (n = 58) | |
| Age, years, mean (SD) | 64.9 (9.1) | 65.4 (8.1) | 66.2 (8.7) | 64.9 (8.9) |
| Gender, male, n (%) | 65 (68.4) | 31 (66.0) | 79 (66.4) | 32 (55.2) |
| BMI, kg/m2, mean (SD) | 33.0 (5.4) | 32.7 (4.9) | 32.6 (4.5) | 33.4 (5.8) |
| CHD, n (%) | 90 (94.7) | 45 (95.7) | 102 (85.7) | 51 (87.9) |
| Acute MI | 43 (45.3) | 20 (42.6) | 59 (49.6) | 18 (31.0) |
| Silent MI | 5 (5.3) | 1 (2.1) | 4 (3.4) | 4 (6.9) |
| Unstable angina | 15 (15.8) | 9 (19.1) | 15 (12.6) | 4 (6.9) |
| Coronary revascularization | 77 (81.1) | 35 (74.5) | 80 (67.2) | 37 (63.8) |
| Other clinically significant CHDa | 20 (21.1) | 14 (29.8) | 31 (26.1) | 15 (25.9) |
| Ischemic stroke, n (%) | 14 (14.7) | 5 (10.6) | 27 (22.7) | 9 (15.5) |
| PAD, n (%) | 6 (6.3) | 4 (8.5) | 13 (10.9) | 6 (10.3) |
| HTNb, n (%) | 89 (93.7) | 44 (93.6) | 105 (88.2) | 53 (91.4) |
| CKDc, n (%) | 15 (15.8) | 11 (23.4) | 37 (31.1) | 13 (22.4) |
| Diabetes target organ damaged, n (%) | 31 (32.6) | 15 (31.9) | 60 (50.4) | 28 (48.3) |
| Statin, n (%) | 80 (84.2) | 41 (87.2) | 92 (77.3) | 42 (72.4) |
| Low intensity | 6 (7.5) | 0 | 3 (3.3) | 1 (2.4) |
| Moderate intensity | 21 (26.3) | 20 (48.8) | 46 (50.0) | 24 (57.1) |
| High intensity | 53 (66.3) | 21 (51.2) | 43 (46.7) | 16 (38.1) |
| LLT other than statine, n (%) | 0 | 2 (4.3) | 34 (28.6) | 11 (19.0) |
| HbA1c, %, mean (SD) | 7.0 (0.8) | 7.2 (0.8) | 7.5 (0.9) | 7.4 (1.0) |
| FPG, mg/dL [mmol/L], mean (SD) | 144.1 (39.3) [8.0 (2.2)] | 152.6 (41.7) [8.5 (2.3)] | 162.6 (52.5) [9.0 (2.9)] | 146.7 (45.2) [8.1 (2.5)] |
| Insulin, n (%) | 40 (42.1) | 19 (40.4) | 119 (100) | 57 (98.3)f |
| Non-insulin GLT, n (%) | ||||
| Biguanides | 72 (75.8) | 34 (72.3) | 57 (47.9) | 33 (56.9) |
| Sulfonylureas | 29 (30.5) | 18 (38.3) | 11 (9.2) | 7 (12.1) |
| DPP-4 inhibitor | 12 (12.6) | 8 (17.0) | 21 (17.6) | 7 (12.1) |
| GLP-1 receptor agonist | 16 (16.8) | 6 (12.8) | 11 (9.2) | 8 (13.8) |
| SGLT2 inhibitor | 10 (10.5) | 5 (10.6) | 10 (8.4) | 11 (19.0) |
| Lipids, mg/dL [mmol/L], mean (SD) | ||||
| Non-HDL-C | 156.5 (48.4) [4.05 (1.26)] | 156.8 (43.3) [4.06 (1.12)] | 142.8 (41.5) [3.70 (1.08)] | 147.0 (54.9) [3.81 (1.42)] |
| LDL-C | 108.3 (46.3) [2.81 (1.20)] | 109.4 (44.0) [2.83 (1.14)] | 107.2 (35.1) [2.78 (0.91)] | 111.9 (46.4) [2.90 (1.20)] |
| ApoB | 103.0 (26.7) | 104.3 (27.8) | 96.4 (25.1) | 98.7 (32.0) |
| LDL-PN, nmol/L, mean (SD) | 1400.2 (489.8) | 1437.4 (479.4) | 1339.5 (408.5) | 1425.0 (467.9) |
Apo apolipoprotein, BMI body mass index, CHD coronary heart disease, CKD chronic kidney disease, DPP-4 dipeptidyl peptidase-4, GLP-1 glucagon-like peptide-1, GLT glucose-lowering treatment, FPG fasting plasma glucose, HbA1c glycated hemoglobin, HDL-C high-density lipoprotein cholesterol, HTN hypertension, LDL-C low-density lipoprotein cholesterol, LDL-PN low-density lipoprotein particle number, LLT lipid-lowering therapy, MI myocardial infarction, PAD peripheral artery disease, SD standard deviation, SGLT2 sodium glucose cotransporter 2
aDiagnosis by invasive/non-invasive testing
bIncludes patients with established HTN on anti-HTN medication
cDefined as estimated glomerular filtration rate 15–60 mL/min/1.73 m2
dDefined as microalbuminuria, macroalbuminuria, retinopathy, and/or CKD
eLLT other than statins were not allowed per protocol in DM DYSLIPIDEMIA
fOne individual in the placebo group was not receiving insulin at the time of randomization and remained without insulin treatment for the duration of the study