Table 1.
Baseline characteristics of randomized patients with DM and ASCVD
| Study pools | Alirocumab 150 mg Q2W vs placebo (with statin) | Alirocumab 75/150 mg Q2W vs placebo (with statin) | Alirocumab 75/150 mg Q2W vs ezetimibe (with statin) | Alirocumab 75/150 mg Q2W vs ezetimibe (without statin) | ||||
|---|---|---|---|---|---|---|---|---|
| Treatment groups | Alirocumab (n = 346) | Placebo (n = 176) | Alirocumab (n = 93) | Placebo (n = 46) | Alirocumab (n = 176) | Ezetimibe (n = 112) | Alirocumab (n = 23) | Ezetimibe (n = 12) |
| Age, years, mean ± SD | 63.2 ± 8.7 | 62.0 ± 9.5 | 64.0 ± 8.9 | 62.7 ± 9.1 | 64.2 ± 9.3 | 64.6 ± 8.8 | 70.3 ± 7.1 | 63.0 ± 7.6 |
| Males, n (%) | 218 (63.0) | 104 (59.1) | 60 (64.5) | 29 (63.0) | 122 (69.3) | 78 (69.6) | 14 (60.9) | 9 (75.0) |
| Race, white, n (%) | 302 (87.3) | 158 (89.8) | 72 (77.4) | 36 (78.3) | 147 (83.5) | 90 (80.4) | 21 (91.3) | 11 (91.7) |
| BMI, kg/m2, mean ± SD | 31.9 ± 5.7 | 32.1 ± 5.2 | 33.2 ± 6.5 | 33.5 ± 7.2 | 31.7 ± 6.3 | 32.8 ± 5.8 | 31.9 ± 6.3 | 29.5 ± 3.7 |
| HbA1c, %, median (Q1:Q3) | 6.7 (6.1:7.8) | 6.9 (6.1:8.0) | 6.6 (6.1:7.3) | 6.4 (5.9:7.2) | 6.8 (6.2:7.5) | 6.7 (6.1:7.4) | 6.5 (5.9:6.8) | 6.2 (6.0:7.0) |
| FPG, mg/dL, median (Q1:Q3) | 127.9 (108.1:154.9) | 129.7 (108.1:162.5) | 121.0 (104.0:151.3) | 119.0 (104.0:138.0) | 131.0 (110.5:149.5) | 122.3 (102.8:142.3) | 127.9 (101.0:145.0) | 117.6 (101.0:150.8) |
| HeFH, n (%) | 23 (6.6) | 17 (9.7) | 23 (24.7) | 20 (43.5) | 1 (0.6) | 0 | 0 | 0 |
| Insulin usage, n (%) | 85 (24.6) | 48 (27.3) | 22 (23.7) | 5 (10.9) | 42 (23.9) | 19 (17.0) | 8 (34.8) | 5 (41.7) |
| Statin usage, n (%) | 345 (99.7) | 176 (100.0) | 93 (100.0) | 46 (100.0) | 176 (100.0) | 112 (100.0) | 1 (4.3) | 0 |
| High‐intensity statina usage, n (%) | 151 (43.6) | 83 (47.2) | 62 (66.7) | 32 (69.6) | 111 (63.1) | 65 (58.0) | 0 | 0 |
| ASCVD history, n (%) | ||||||||
| CHD | 304 (87.9) | 149 (84.7) | 84 (90.3) | 44 (95.7) | 161 (91.5) | 105 (93.8) | 21 (91.3) | 12 (100.0) |
| Acute coronary syndromeb | 195 (56.4) | 101 (57.4) | 52 (55.9) | 33 (71.7) | 108 (61.4) | 66 (58.9) | 10 (43.5) | 8 (66.7) |
| Coronary revascularization procedure | 202 (58.4) | 101 (57.4) | 69 (74.2) | 32 (69.6) | 108 (61.4) | 77 (68.8) | 13 (56.5) | 10 (83.3) |
| Other clinically significant CHD | 118 (34.1) | 57 (32.4) | 27 (29.0) | 17 (37.0) | 77 (43.8) | 60 (53.6) | 12 (52.2) | 7 (58.3) |
| Peripheral arterial disease | 29 (8.4) | 21 (11.9) | 3 (3.2) | 2 (4.3) | 18 (10.2) | 6 (5.4) | 0 | 1 (8.3) |
| Ischaemic stroke | 48 (13.9) | 24 (13.6) | 12 (12.9) | 2 (4.3) | 23 (13.1) | 12 (10.7) | 2 (8.7) | 1 (8.3) |
| Hypertension, n (%) | 314 (90.8) | 157 (89.2) | 86 (92.5) | 43 (93.5) | 159 (90.3) | 104 (92.9) | 21 (91.3) | 10 (83.3) |
| Lipid parameters, mean ± SD, mg/dL | ||||||||
| Calculated LDL‐C | 117.3 ± 36.1 | 120.6 ± 39.6 | 105.2 ± 34.3 | 114.2 ± 47.1 | 105.6 ± 32.3 | 97.8 ± 29.5 | 157.6 ± 33.6 | 194.4 ± 84.3 |
| Non‐HDL‐C | 152.0 ± 41.5 | 153.0 ± 45.5 | 135.8 ± 38.1 | 143.0 ± 53.7 | 139.3 ± 41.0 | 129.2 ± 31.8 | 196.9 ± 42.6 | 253.0 ± 72.7 |
| ApoB | 102.3 ± 26.1 | 102.6 ± 28.2 | 95.4 ± 25.4 | 96.0 ± 30.2 | 95.7 ± 23.8 | 88.3 ± 17.4 | 125.7 ± 23.2 | 150.1 ± 37.3 |
| Lp(a), median (Q1:Q3) | 20.1 (6.0:54.1) | 17.2 (6.0:61.9) | 38.5 (7.0:86.0) | 43.5 (12.5:105.5) | 27.0 (8.0:63.0) | 19.5 (9.5:50.0) | 28.0 (7.0:71.0) | 8.0 (3.0:26.0) |
| Triglycerides, median (Q1:Q3) | 154.9 (111.5:215.0) | 148.7 (105.2:205.3) | 133.0 (100.0:173.0) | 120.0 (101.0:188.0) | 146.5 (109.0:208.5) | 146.5 (112.5:188.0) | 201.0 (125.0:272.0) | 247.0 (140.5:346.5) |
| HDL‐C | 47.9 ± 10.8 | 47.5 ± 12.4 | 44.8 ± 13.2 | 46.0 ± 12.5 | 43.5 ± 11.2 | 43.6 ± 10.7 | 43.7 ± 12.5 | 45.3 ± 11.1 |
Abbreviations: Apo, apolipoprotein; ASCVD, atherosclerotic cardiovascular disease; BMI, body mass index; CHD, coronary heart disease; DM, diabetes mellitus; FPG, fasting plasma glucose; HbA1c, glycated haemoglobin; HDL‐C, high‐density lipoprotein cholesterol; HeFH, heterozygous familial hypercholesterolaemia; LDL‐C, low‐density lipoprotein cholesterol; Lp(a), lipoprotein(a); MI, myocardial infarction; Q2W, every 2 weeks; SD, standard deviation.
a
Atorvastatin 40 or 80 mg, rosuvastatin 20 or 40 mg or simvastatin 80 mg daily.
b
Includes silent MI, acute MI and unstable angina.