Table 1.
Patient baseline characteristics and baseline lipids (randomized population)
| ALI 150 vs PBO (with statins) | ALI 75/150 vs PBO (with statins) | ALI 75/150 vs EZE (with statins) | ALI 75/150 vs EZE (without statins) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| ALI | PBO | ALI | PBO | ALI | EZE | ALI | EZE | ||
| Group, n | MetS | 599 | 334 | 294 | 137 | 254 | 168 | 75 | 79 |
| Non‐MetS | 429 | 184 | 261 | 131 | 166 | 100 | 60 | 70 | |
| Age, years, mean (SD) | MetS | 59.5 (10.5) | 60.4 (9.9) | 56.7 (12.2) | 55.2 (13.1) | 61.3 (9.5) | 61.9 (9.8) | 62.6 (8.2) | 63.2 (8.3) |
| Non‐MetS | 58.3 (12.1) | 58.6 (12.2) | 50.6 (13.6) | 52.6 (12.5) | 60.7 (9.7) | 60.3 (11.2) | 61.8 (7.3) | 59.9 (10.5) | |
| Male, % (n) | MetS | 65.8 (394) | 66.2 (221) | 60.9 (179) | 64.2 (88) | 74.0 (188) | 70.2 (118) | 58.7 (44) | 54.4 (43) |
| Non‐MetS | 64.3 (276) | 62.5 (115) | 52.5 (137) | 58.8 (77) | 74.1 (123) | 70.0 (70) | 51.7 (31) | 50.0 (35) | |
| Race, white, % (n) | MetS | 96.2 (576) | 96.4 (322) | 94.9 (279) | 91.2 (125) | 85.4 (217) | 91.7 (154) | 94.7 (71) | 87.3 (69) |
| Non‐MetS | 97.9 (420) | 96.7 (178) | 93.5 (244) | 94.7 (124) | 90.4 (150) | 88.0 (88) | 95.0 (57) | 98.6 (69) | |
| BMI, kg/m2, mean (SD) | MetS | 30.8 (5.3) | 30.6 (4.7) | 31.0 (4.4) | 30.9 (5.8) | 31.1 (5.2) | 30.7 (5.0) | 30.7 (5.1) | 30.3 (5.4) |
| Non‐MetS | 26.6 (3.7) | 26.5 (3.5) | 26.9 (4.0) | 27.0 (4.0) | 26.3 (3.2) | 26.8 (3.5) | 25.4 (3.3) | 25.1 (3.0) | |
| SBP, mm Hg, mean (SD) | MetS | 135.2 (15.7) | 135.2 (13.8) | 131.5 (13.7) | 129.3 (12.5) | 132.3 (14.0) | 131.9 (11.8) | 131.5 (12.6) | 130.4 (12.9) |
| Non‐MetS | 124.7 (15.1) | 125.5 (15.1) | 121.3 (12.9) | 122.4 (14.2) | 124.7 (14.1) | 121.9 (12.9) | 123.3 (13.4) | 124.4 (13.3) | |
| HbA1c, %, mean (SD) | MetS | 5.7 (0.4) | 5.6 (0.3) | 5.7 (0.4) | 5.6 (0.3) | 5.7 (0.3) | 5.7 (0.4) | 5.7 (0.3) | 5.6 (0.4) |
| Non‐MetS | 5.6 (0.3) | 5.6 (0.3) | 5.5 (0.3) | 5.5 (0.3) | 5.6 (0.3) | 5.6 (0.3) | 5.5 (0.3) | 5.5 (0.3) | |
| FPG, mg/dL, mean (SD) | MetS | 101.3 (11.5) | 100.0 (11.9) | 101.1 (12.3) | 100.4 (10.0) | 104.2 (11.4) | 101.7 (11.8) | 101.7 (15.4) | 98.6 (10.2) |
| Non‐MetS | 93.6 (9.7) | 94.0 (10.8) | 92.4 (9.3) | 93.3 (12.0) | 97.8 (15.2) | 96.9 (14.6) | 93.9 (11.7) | 93.0 (8.5) | |
| Hypertension, % (n) | MetS | 80.3 (481) | 82.9 (277) | 67.3 (198) | 65.0 (89) | 83.1 (211) | 88.1 (148) | 72.0 (54) | 72.2 (57) |
| Non‐MetS | 37.8 (162) | 39.7 (73) | 21.8 (57) | 22.9 (30) | 57.8 (96) | 46.0 (46) | 20.0 (12) | 18.6 (13) | |
| ASCVD,a % (n) | MetS | 85.8 (514) | 88.3 (295) | 61.6 (181) | 66.4 (91) | 91.3 (232) | 89.9 (151) | 44.0 (33) | 43.0 (34) |
| Non‐MetS | 76.5 (328) | 77.2 (142) | 42.9 (112) | 39.7 (52) | 90.4 (150) | 82.0 (82) | 23.3 (14) | 15.7 (11) | |
| Very high cardiovascular risk, % (n) | MetS | 87.5 (524) | 91.3 (305) | 63.6 (187) | 69.3 (95) | 92.5 (235) | 90.5 (152) | 44.0 (33) | 45.6 (36) |
| Non‐MetS | 78.8 (338) | 78.3 (144) | 44.4 (116) | 41.2 (54) | 91.0 (151) | 82.0 (82) | 25.0 (15) | 15.7 (11) | |
| LDL‐C, mg/dL, mean (SD) | MetS | 129.9 (50.6) | 128.9 (47.7) | 132.6 (48.7) | 134.0 (48.6) | 111.9 (37.5) | 106.1 (38.2) | 184.5 (69.3) | 174.2 (58.4) |
| Non‐MetS | 131.9 (48.3) | 129.4 (46.1) | 132.9 (47.0) | 131.6 (40.3) | 109.7 (38.4) | 110.3 (42.8) | 177.6 (73.0) | 182.7 (75.3) | |
| HDL‐C, mg/dL, mean (SD) | MetS | 47.7 (11.5) | 48.3 (12.2) | 47.8 (14.9) | 46.4 (13.7) | 46.7 (13.1) | 47.3 (12.6) | 46.9 (13.0) | 47.3 (10.1) |
| Non‐MetS | 55.2 (13.2) | 54.9 (11.2) | 56.4 (15.6) | 55.5 (15.0) | 55.0 (12.6) | 53.9 (13.5) | 60.1 (17.0) | 61.9 (18.8) | |
| TGs, mg/dL, median (Q1:Q3) | MetS | 145.1 (108.8:198.0) | 154.0 (108.8:197.3) | 141.0 (97.0:196.0) | 134.5 (101.0:174.0) | 148.5 (109.0:200.0) | 154.5 (112.5:207.0) | 174.0 (135.0:235.0) | 163.0 (115.0:225.0) |
| Non‐MetS | 93.8 (75.0:126.5) | 99.1 (73.7:124.9) | 93.0 (72.0:121.0) | 90.0 (72.0:109.0) | 98.0 (76.0:127.0) | 96.5 (78.0:118.5) | 100.0 (74.5:120.5) | 93.0 (77.0:128.0) | |
| TGs in patients on non‐statin LLTs | MetS | 130.5 (96.0: 177.9) | 145.1 (95.0: 196.0) | 125.0 (93.5: 180.5) | 123.0 (97.0: 170.0) | 131.0 (106.0: 208.0) | 142.0 (95.0: 191.5) | 207.0 (132.0: 240.0) | 197.0 (120.0: 232.5) |
| Non‐MetS | 88.0 (72.0: 111.5) | 94.7 (67.7: 126.5) | 89.0 (70.0: 109.0) | 90.0 (70.5: 104.5) | 89.0 (79.5: 106.0) | 111.0 (107.0: 113.0) | 122.0 (105.0: 125.0) | 108.0 (83.0: 129.0) | |
| TGs in patients not on non‐statin LLTs | MetS | 153.1 (115.9: 205.0) | 158.0 (115.9: 199.0) | 170.5 (118.0: 211.0) | 147.0 (113.0: 198.0) | 153.0 (110.0: 199.0) | 159.0 (115.0: 218.5) | 172.5 (153.0: 233.0) | 159.0 (112.0: 218.0) |
| Non‐MetS | 95.6 (75.0: 131.0) | 99.1 (78.8: 124.4) | 95.0 (72.0: 126.0) | 91.0 (73.0: 120.0) | 99.0 (76.0: 129.0) | 96.0 (78.0: 120.0) | 95.0 (74.0: 119.0) | 91.0 (73.0: 128.0) | |
Abbreviations: ALI, alirocumab; ASCVD, atherosclerotic cardiovascular disease; BMI, body mass index; EZE, ezetimibe; FPG, fasting plasma glucose; HbA1c, glycated haemoglobin; HDL‐C, high‐density lipoprotein cholesterol; LDL‐C, low‐density lipoprotein cholesterol; LLTs, lipid‐lowering therapies; MetS, metabolic syndrome; PBO, placebo; SBP, systolic blood pressure; SD, standard deviation; TGs, triglycerides.
a
Including coronary heart disease, peripheral arterial disease and ischaemic stroke; transient ischaemic attack, carotid endarterectomy or carotid artery stent procedure, and renal artery stent procedure were also included in the definition used for the FH II, ALTERNATIVE and OPTIONS I & II trials.