| 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) |