TABLE 1.
Baseline demographics and characteristics by baseline glycaemic status
| Variable | Diabetes a | Prediabetes b | Normoglycaemia c | |||
|---|---|---|---|---|---|---|
| BA (n = 755) | Placebo (n = 380) | BA (n = 1259) | Placebo (n = 609) | BA (n = 410) | Placebo (n = 208) | |
| Age, mean (SD), y | 65.7 (8.7) | 67.0 (8.3) | 65.3 (9.1) | 65.8 (8.9) | 64.1 (10.6) | 64.6 (10.2) |
| Male, % (n) | 64.8 (489) | 63.9 (243) | 69.1 (870) | 67.2 (409) | 58.8 (241) | 61.1 (127) |
| White, % (n) | 91.1 (688) | 93.9 (357) | 95.9 (1208) | 94.9 (578) | 95.9 (393) | 93.8 (195) |
| BMI, mean (SD), kg/m2 | 31.7 (5.3) | 31.7 (5.4) | 29.4 (4.8) | 29.4 (4.8) | 27.6 (4.2) | 28.0 (4.1) |
| eGFR category, % (n) | ||||||
| ≥90 ml/min/1.73m2 | 26.8 (202) | 21.1 (80) | 19.3 (243) | 21.2 (129) | 20.7 (85) | 22.1 (46) |
| ≥60 to <90 ml/min/1.73m2 | 54.8 (414) | 59.7 (227) | 66.2 (834) | 65.4 (398) | 69.3 (284) | 63.9 (133) |
| <60 ml/min/1.73m2 | 18.4 (139) | 19.2 (73) | 14.5 (182) | 13.5 (82) | 10.0 (41) | 13.9 (29) |
| Fasting glucose, mean (SD), mg/dl | 130.8 (38.0) | 129.7 (37.4) | 100.3 (10.6) | 100.0 (10.8) | 89.7 (6.2) | 90.1 (6.2) |
| HbA1c, mean (SD) | ||||||
| %, mean (SD) | 6.8 (1.0) | 6.8 (1.0) | 5.8 (0.3) | 5.8 (0.3) | 5.4 (0.2) | 5.4 (0.2) |
| mmol/mol, mean | 51 | 51 | 40 | 40 | 36 | 36 |
| On antihyperglycaemic medication at baseline, d % (n) | 75.5 (570) | 73.9 (281) | — | — | — | — |
| On insulin at baseline, e % (n) | 18.5 (140) | 21.6 (82) | — | — | — | — |
| History of hypertension, % | 86.5 (653) | 89.2 (339) | 77.0 (970) | 76.4 (465) | 62.7 (257) | 67.3 (140) |
| History of ASCVD, % | 83.6 (631) | 84.5 (321) | 80.5 (1013) | 81.8 (498) | 74.9 (307) | 74.5 (155) |
| Lipid variables mean (SD), mg/dl | ||||||
| Total cholesterol | 189.6 (41.2) | 188.4 (40.8) | 194.5 (44.4) | 194.2 (45.5) | 199.1 (45.0) | 193.4 (42.8) |
| Non‐HDL‐C | 142.4 (39.5) | 141.3 (40.2) | 144.0 (42.7) | 143.2 (43.3) | 144.6 (43.6) | 139.2 (39.8) |
| LDL‐C | 110.1 (33.6) | 109.6 (33.7) | 115.2 (37.2) | 115.0 (38.4) | 119.1 (39.1) | 113.9 (35.3) |
| HDL‐C | 47.1 (11.7) | 47.1 (10.4) | 50.5 (12.8) | 51.0 (14.6) | 54.5 (13.8) | 54.2 (12.5) |
| Triglycerides, median (Q1, Q3), mg/dl | 148.0 (114.5, 202.0) | 144.5 (110.8, 192.8) | 131.0 (100.0, 176.5) | 127.0 (97.0, 177.5) | 114.2 (88.0, 154.0) | 114.0 (88.0, 149.2) |
| Apo B, mean (SD), mg/dl | 101.6 (29.6) | 101.3 (30.9) | 102.4 (31.7) | 101.5 (32.0) | 101.9 (31.0) | 97.6 (29.7) |
| hsCRP, median (Q1, Q3), mg/dl | 2.1 (1.0, 4.6) | 2.1 (1.0, 5.2) | 1.6 (0.8, 3.3) | 1.6 (0.8, 3.5) | 1.3 (0.7, 2.8) | 1.3 (0.7, 2.5) |
| Baseline LLT use, % (n) | ||||||
| Statin alone | 71.0 (536) | 70.8 (269) | 70.1 (882) | 71.9 (438) | 69.3 (284) | 67.3 (140) |
| Statin plus other LLT | 14.3 (108) | 13.9 (53) | 13.3 (167) | 12.8 (78) | 12.9 (53) | 13.0 (27) |
| Other LLT alone | 7.9 (60) | 8.2 (31) | 9.3 (117) | 8.9 (54) | 12.7 (52) | 12.5 (26) |
| None | 6.8 (51) | 7.1 (27) | 7.4 (93) | 6.4 (39) | 5.1 (21) | 7.2 (15) |
| Baseline statin intensity, % (n) | ||||||
| None | 14.7 (111) | 15.3 (58) | 16.7 (210) | 15.3 (93) | 17.8 (73) | 19.7 (41) |
| Low f | 8.2 (62) | 6.3 (24) | 7.6 (96) | 7.4 (45) | 10.5 (43) | 12.0 (25) |
| Moderate | 37.4 (282) | 37.1 (141) | 31.1 (392) | 31.9 (194) | 33.2 (136) | 33.2 (69) |
| High | 39.7 (300) | 41.3 (157) | 44.6 (561) | 45.5 (277) | 38.5 (158) | 35.1 (73) |
| Baseline ezetimibe use, % (n) | 11.4 (86) | 12.1 (46) | 16.4 (206) | 14.6 (89) | 17.8 (73) | 20.7 (43) |
Abbreviations: Apo B, apolipoprotein B; ASCVD, atherosclerotic cardiovascular disease; BA, bempedoic acid; BMI, body mass index; eGFR, estimated glomerular filtration rate; hsCRP, high‐sensitivity C‐reactive protein; LLT, lipid‐lowering therapy; SD, standard deviation.
Patients with one or more of the following: history of type 1 or type 2 diabetes; receiving diabetes medication prior to baseline; and/or HbA1c ≥ 6.5% at baseline, or at least one fasting plasma glucose value of ≥100 mg/dl, but not more than one value of ≥126 mg/dl between screening and randomization.
Patients with all of the following: no medical history of diabetes; not receiving diabetes medication prior to baseline; and HbA1c of 5.7% to 6.4% (inclusive) at baseline, or at least one fasting glucose value of ≥100 mg/dl, but not more than one value of ≥126 mg/dl between screening and randomization.
Patients not fulfilling the criteria for diabetes or prediabetes.
Included insulin and non‐insulin medications.
Included insulin and analogues.
Included low‐dose or very‐low‐dose statin regimens in studies that enrolled patients with statin intolerance.