Table 1.
Demographic, clinical, pharmacologic, and laboratory characteristics of the BETonMACE trial participants at baseline according to CKD status and assigned treatment group
| Characteristics | Full Study Cohort according to CKD Status a | Patients with CKD by Assigned Treatment Group b | ||
|---|---|---|---|---|
| eGFR ≥60 ml/min per 1.73 m2 (no-CKD) | eGFR <60 ml/min per 1.73 m2 (CKD) | Placebo (eGFR <60 ml/min per 1.73 m2) | Apabetalone (eGFR <60 ml/min per 1.73 m2) | |
| No. of participants | 2125 | 288 | 164 | 124 |
| Age, yr | 61 (54–67) | 71 (65–76) | 71 (66–77) | 70 (65–75) |
| Female, n (%) | 497 (23) | 120 (42) | 72 (44) | 48 (39) |
| White race, n (%) | 1879 (88) | 235 (82) | 137 (84) | 98 (79) |
| Asian race, n (%) | 28 (1) | 11 (4) | 5 (3) | 6 (5) |
| Body mass index, kg/m2 | 30.6 (4.9) | 27.4 (3.9) | 27.5 (4.1) | 27.2 (3.6) |
| Hypertension history, n (%) | 1876 (88) | 263 (91) | 148 (90) | 115 (93) |
| Smoking status, n (%) | 253 (12) | 19 (7) | 11 (7) | 8 (6) |
| Diabetes duration, yr | 8.2 (7.3) | 11.3 (9.1) | 11.9 (9.1) | 10.5 (9.1) |
| Prior myocardial infarction, n (%) | 300 (14) | 49 (17) | 27 (16) | 22 (18) |
| Prior revascularization, n (%) | 442 (21) | 71 (25) | 37 (23) | 34 (27) |
| Index acute coronary syndrome c | ||||
| Myocardial infarction, n (%) | 1560 (74) | 215 (75) | 126 (78) | 89 (72) |
| NSTEMI, n (%) | 718 (46) | 116 (55) | 68 (55) | 48 (54) |
| STEMI, n (%) | 835 (54) | 96 (45) | 56 (45) | 40 (45) |
| Unstable angina, n (%) | 553 (26) | 70 (25) | 36 (22) | 34 (28) |
| Time from index ACS, d | 38 (25–63) | 35 (23–57) | 36 (23–58) | 33 (23–54) |
| Cardiovascular medications, n (%) | ||||
| Atorvastatin | 1084 (51) | 153 (53) | 91 (55) | 62 (50) |
| Rosuvastatin | 1041 (49) | 135 (47) | 73 (45) | 62 (50) |
| Intensive statin therapy | 1929 (91) | 247 (86) | 139 (85) | 108 (87) |
| Ezetimibe | 50 (2) | 17 (6) | 13 (8) | 4 (3) |
| ACE inhibitors or ARB | 1957 (92) | 268 (93) | 154 (94) | 114 (92) |
| β-Blockers | 1925 (91) | 262 (91) | 150 (91) | 112 (90) |
| Antiplatelet agents | 2099 (99) | 287 (99) | 164 (100) | 123 (99) |
| Diabetes medications, n (%) | ||||
| Metformin | 1794 (84) | 200 (69) | 104 (63) | 96 (77) |
| Insulin | 787 (37) | 121 (42) | 74 (45) | 47 (38) |
| Sulfonylureas | 619 (29) | 88 (31) | 46 (28) | 42 (34) |
| DPP4 inhibitors | 307 (14) | 51 (18) | 28 (17) | 23 (19) |
| SGLT2 inhibitors | 279 (13) | 18 (6) | 9 (5) | 9 (7) |
| GLP1 receptor agonists | 81 (4) | 5 (2) | 4 (2) | 1 (0.8) |
| Other d | 90 (4) | 17 (6) | 10 (6) | 7 (6) |
| Biochemical parameters | ||||
| Serum creatinine, mg/dl | 0.90 (0.21) | 1.4 (0.5) | 1.4 (0.5) | 1.4 (0.4) |
| eGFR, ml/min per 1.73 m2 | 111 (35) | 49 (9) | 48 (9) | 49 (9) |
| eGFR 45 to <60 ml/min per 1.73 m 2 | N/A | 186 (65) | 104 (63) | 82 (66) |
| eGFR <45 ml/min per 1.73 m 2 | N/A | 102 (35) | 57 (35) | 41 (33) |
| HbA1c, % | 7.3 (6.4–8.7) | 7.2 (6.4–8.5) | 7.1 (6.4–8.4) | 7.3 (6.5–8.6) |
| Serum glucose, mg/dl | 152 (61) | 149 (66) | 147 (65) | 151 (68) |
| Total cholesterol, mg/dl | 135 (35) | 140 (46) | 145 (49) | 134 (41) |
| LDL cholesterol, mg/dl | 70 (30) | 73 (39) | 77 (42) | 69 (35) |
| HDL cholesterol, mg/dl | 33 (5) | 33 (6) | 34 (6) | 33 (5) |
| Triglycerides, mg/dl | 147 (113–200) | 157 (117–202) | 163 (130–205) | 145 (107–190) |
| Alkaline phosphatase, U/L | 81 (29) | 91 (71) | 90 (61) | 93 (83) |
| Alanine aminotransferase, U/L | 26 (14) | 23 (18) | 24 (22) | 21 (10) |
| Systolic BP (mm Hg) | 129 (15) | 129 (15) | 128 (16) | 131 (14) |
| Diastolic BP (mm Hg) | 77 (9) | 75 (9) | 75 (10) | 75 (9) |
| Total bilirubin, umol/L | 0.6 (0.2) | 0.6 (0.3) | 0.6 (0.3) | 0.6 (0.3) |
| hsCRP, mg/L | 2.7 (1.2–5.9) | 3.2 (1.1–7.6) | 3.9 (1.1–10.1) | 3.0 (1.3–5.7) |
| NLR | 2.5 (1.9–3.3) | 2.9 (2.2–3.9) | 2.9 (2.2–4.0) | 2.8 (2.1–3.7) |
Continuous variables are presented as mean (SD) or median (interquartile range). Categoric variables are presented as n (%). NSTEMI, non–ST-segment elevation myocardial infarction; STEMI, ST-segment elevation myocardial infarction; ACS, acute coronary syndrome; ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blocker; DPP4, dipeptidyl peptidase-4; SGLT2, sodium-glucose cotransporter 2; GLP1, glucagon-like peptide 1; N/A, not applicable; HbA1c, hemoglobin A1C; hsCRP, high-sensitivity C-reactive protein; NLR, neutrophil/lymphocyte ratio.
Data for the full study cohort according to baseline CKD status.
Data for the CKD subgroup according to assigned treatment group.
There was no significant difference in proportion of myocardial infarction versus unstable angina as an index event (P=0.61); but, among those with myocardial infarction as the index event, there were significant differences in proportion of STEMI versus non-STEMI (P=0.03).
Other diabetes medications include acarbose, pioglitazone, and repaglinide.