Table 1.
Baseline demographic and clinical characteristics (ITT population)
| Characteristics | ORION-9, ORION-10 and ORION-11 pooled15 | ORION-913 | ORION-1014 | ORION-1114 | ||||
|---|---|---|---|---|---|---|---|---|
| Inclisiran | Placebo | Inclisiran | Placebo | Inclisiran | Placebo | Inclisiran | Placebo | |
| n = 1833 | n = 1827 | n = 242 | n = 240 | n = 781 | n = 780 | n = 810 | n = 807 | |
| Age, years, mean (SD) | 64.1 (9.98) | 63.9 (9.87) | 56 (47–63)a | 56 (46–64)a | 66.4 (8.9) | 65.7 (8.9) | 64.8 (8.3) | 64.8 (8.7) |
| Male, n (%) | 1226 (66.9) | 1244 (68.1) | 112 (46.3) | 115 (47.9) | 535 (68.5) | 548 (70.3) | 579 (71.5) | 581 (72.0) |
| ASCVD, n (%) | 1552 (84.7) | 1555 (85.1) | 59 (24.4) | 73 (30.4) | 781 (100) | 780 (100) | 712 (87.9) | 702 (87.0) |
| Prior MI, n (%) | 831 (45.3) | 863 (47.2) | 22 (9.1) | 29 (12.1) | 375 (48.0) | 410 (52.6) | 434 (53.6) | 424 (52.5) |
| CHF, n (%) | 213 (11.6) | 227 (12.4) | 4 (1.7) | 9 (3.8) | 100 (12.8) | 116 (14.9) | 109 (13.5) | 102 (12.6) |
| CV risk factors, n (%) | ||||||||
| ȃSmoking (current) | 311 (17.0) | 271 (14.8) | 28 (11.6) | 28 (11.7) | 123 (15.7) | 111 (14.2) | 160 (19.8) | 132 (16.4) |
| ȃHypertension | 1456 (79.4) | 1463 (80.1) | 102 (42.1) | 101 (42.1) | 714 (91.4) | 701 (89.9) | 640 (79.0) | 661 (81.9) |
| ȃDiabetes | 687 (37.5) | 631 (34.5) | 20 (8.3) | 28 (11.7) | 371 (47.5) | 331 (42.4) | 296 (36.5) | 272 (33.7) |
| Lipid-lowering therapy, n (%) | ||||||||
| ȃStatins | 1686 (92.0) | 1675 (91.7) | 219 (90.5) | 217 (90.4) | 701 (89.8) | 692 (88.7) | 766 (94.6) | 766 (94.9) |
| ȃHigh-intensity statins | 1356 (74.0) | 1345 (73.6) | 185 (76.4) | 171 (71.3) | 538 (68.9) | 546 (70.0) | 633 (78.1) | 628 (77.8) |
| ȃEzetimibe | 251 (13.7) | 270 (14.8) | 119 (49.2) | 134 (55.8) | 80 (10.2) | 74 (9.5) | 52 (6.4) | 62 (7.7) |
| Anti-platelet therapy, n (%) | ||||||||
| ȃASA | 1309 (71.4) | 1286 (70.4) | 84 (34.7) | 89 (37.1) | 614 (78.6) | 614 (78.7) | 611 (75.4) | 583 (72.2) |
| ȃP2Y12ib | 442 (24.1) | 499 (27.3) | 12 (5.0) | 13 (5.4) | 283 (36.2) | 312 (40.0) | 147 (18.1) | 174 (21.6) |
| Lipid measures, mmol/L, mean (SD) | ||||||||
| ȃLDL-C | 2.89 (1.16) | 2.87 (1.13) | 3.92 (1.30) | 4.00 (1.50) | 2.70 (1.02) | 2.71 (0.96) | 2.77 (1.08) | 2.68 (0.94) |
| ȃHDL-C | 1.26 (0.39) | 1.24 (0.36) | 1.33 (0.39) | 1.31 (0.34) | 1.20 (0.37) | 1.19 (0.37) | 1.29 (0.40) | 1.27 (0.36) |
| HbA1c (%), median (IQR) | 5.9 (5.6, 6.5) | 5.9 (5.6, 6.5) | 5.6 (5.4, 5.9) | 5.5 (5.4, 5.8) | 6.1 (5.6, 7.0) | 6.0 (5.6, 6.9) | 5.9 (5.6, 6.5) | 5.9 (5.6, 6.4) |
Age, years, mean (IQR).
P2Y12i includes clopidogrel, prasugrel, and ticagrelor.
ASA, acetylsalicylic acid; ASCVD, atherosclerotic cardiovascular disease; CHF, congestive heart failure; CV, cardiovascular; HbA1c, glycated haemoglobin; HDL-C, high-density lipoprotein cholesterol; ITT, intention-to-treat; IQR, interquartile range; LDL-C, low-density lipoprotein cholesterol; MI, myocardial infarction; n, number of patients; P2Y12i, purinergic signalling receptor Y12 inhibitor; SD, standard deviation.