Table 1.
Baseline characteristics by history of CABG at baseline
| Characteristic | Participants with a history of CABG | Participants without a history of CABG | ||
|---|---|---|---|---|
| Empagliflozin (n = 1175) | Placebo (n = 563) | Empagliflozin (n = 3512) | Placebo (n = 1770) | |
| Age, years | 64.5 ± 8.2 | 65.5 ± 8.0 | 62.6 ± 8.6 | 62.5 ± 8.9 |
| Male | 945 (80.4) | 459 (81.5) | 2391 (68.1) | 1221 (69.0) |
| Race | ||||
| White | 922 (78.5) | 441 (78.3) | 2481 (70.6) | 1237 (69.9) |
| Asian | 191 (16.3) | 78 (13.9) | 815 (23.2) | 433 (24.5) |
| Black/African-American | 51 (4.3) | 35 (6.2) | 186 (5.3) | 85 (4.8) |
| Other/Missing | 11 (0.9) | 9 (1.6) | 30 (0.9) | 15 (0.9) |
| Region | ||||
| Europe | 399 (34.0) | 189 (33.6) | 1527 (43.5) | 770 (43.5) |
| North America (plus Australia and New Zealand) | 389 (33.1) | 201 (35.7) | 543 (15.5) | 261 (14.7) |
| Asia | 138 (11.7) | 58 (10.3) | 759 (21.6) | 392 (22.1) |
| Latin America | 154 (13.1) | 72 (12.8) | 567 (16.1) | 288 (16.3) |
| Africa | 95 (8.1) | 43 (7.6) | 116 (3.3) | 59 (3.3) |
| Weight, kg | 88.8 ± 18.6 | 90.5 ± 19.7 | 85.3 ± 18.9 | 85.4 ± 18.7 |
| BMI, kg/m2 | 30.8 ± 5.1 | 31.2 ± 5.2 | 30.5 ± 5.3 | 30.5 ± 5.2 |
| Time since CABG | ||||
| ≤1 year | 86 (7.3) | 33 (5.9) | n/a | n/a |
| >1 to 5 years | 386 (32.9) | 174 (30.9) | n/a | n/a |
| >5 to 10 years | 373 (31.7) | 170 (30.2) | n/a | n/a |
| >10 years | 322 (27.4) | 181 (32.1) | n/a | n/a |
| CV disease | ||||
| Coronary artery disease | 1175 (100.0) | 563 (100.0) | 2370 (67.5) | 1200 (67.8) |
| Multi-vessel coronary artery disease | 869 (74.0) | 420 (74.6) | 1310 (37.3) | 680 (38.4) |
| History of myocardial infarction | 598 (50.9) | 286 (50.8) | 1592 (45.3) | 797 (45.0) |
| History of strokea | 140 (11.9) | 59 (10.5) | 944 (26.9) | 494 (27.9) |
| Peripheral artery diseaseb | 216 (18.4) | 107 (19.0) | 766 (21.8) | 372 (21.0) |
| Single vessel coronary artery diseasea | 60 (5.1) | 25 (4.4) | 438 (12.5) | 213 (12.0) |
| Cardiac failurec | 119 (10.1) | 70 (12.4) | 343 (9.8) | 174 (9.8) |
| HbA1c, mmol/mold | 64 ± 9.1 | 64 ± 9.3 | 65 ± 9.3 | 65 ± 9.2 |
| HbA1c, %d | 8.05 ± 0.83 | 8.04 ± 0.85 | 8.08 ± 0.85 | 8.09 ± 0.84 |
| Time since diagnosis of type 2 diabetes | ||||
| ≤1 year | 18 (1.5) | 7 (1.2) | 110 (3.1) | 45 (2.5) |
| >1 to 5 years | 125 (10.6) | 63 (11.2) | 587 (16.7) | 308 (17.4) |
| >5 to 10 years | 277 (23.6) | 112 (19.9) | 898 (25.6) | 459 (25.9) |
| >10 years | 755 (64.3) | 381 (67.7) | 1917 (54.6) | 958 (54.1) |
| Glucose-lowering therapy | ||||
| Medication taken alone or in combination | ||||
| Metformin | 840 (71.5) | 411 (73.0) | 2619 (74.6) | 1323 (74.7) |
| Sulfonylurea | 440 (37.4) | 220 (39.1) | 1574 (44.8) | 772 (43.6) |
| Insulin | 675 (57.4) | 318 (56.5) | 1577 (44.9) | 817 (46.2) |
| Monotherapy | 340 (28.9) | 171 (30.4) | 1040 (29.6) | 520 (29.4) |
| Dual therapy | 570 (48.5) | 252 (44.8) | 1689 (48.1) | 896 (50.6) |
| Anti-hypertensive therapy | 1127 (95.9) | 550 (97.7) | 3319 (94.5) | 1671 (94.4) |
| Angiotensin-converting enzyme inhibitor/angiotensin receptor blocker | 961 (81.8) | 452 (80.3) | 2837 (80.8) | 1416 (80.0) |
| Beta-blocker | 902 (76.8) | 434 (77.1) | 2154 (61.3) | 1064 (60.1) |
| Diuretic | 572 (48.7) | 281 (49.9) | 1475 (42.0) | 707 (39.9) |
| Calcium channel blocker | 359 (30.6) | 187 (33.2) | 1170 (33.3) | 601 (34.0) |
| Mineralocorticoid receptor antagonist | 96 (8.2) | 36 (6.4) | 209 (6.0) | 100 (5.6) |
| Renin inhibitor | 10 (0.9) | 5 (0.9) | 17 (0.5) | 14 (0.8) |
| Other | 88 (7.5) | 50 (8.9) | 295 (8.4) | 141 (8.0) |
| Lipid-lowering therapy | 1025 (87.2) | 501 (89.0) | 2795 (79.6) | 1363 (77.0) |
| Statin | 974 (82.9) | 481 (85.4) | 2656 (75.6) | 1292 (73.0) |
| Fibrate | 116 (9.9) | 50 (8.9) | 315 (9.0) | 149 (8.4) |
| Ezetimibe | 65 (5.5) | 26 (4.6) | 124 (3.5) | 55 (3.1) |
| Niacin | 40 (3.4) | 13 (2.3) | 51 (1.5) | 22 (1.2) |
| Other | 137 (11.7) | 69 (12.3) | 228 (6.5) | 106 (6.0) |
| Anticoagulant | 1098 (93.4) | 536 (95.2) | 3064 (87.2) | 1554 (87.8) |
| Acetylsalicylic acid | 1035 (88.1) | 496 (88.1) | 2841 (80.9) | 1431 (80.8) |
| Clopidogrel | 98 (8.3) | 48 (8.5) | 396 (11.3) | 201 (11.4) |
| Vitamin K antagonist | 79 (6.7) | 59 (10.5) | 187 (5.3) | 97 (5.5) |
| Systolic blood pressure, mmHg | 135.5 ± 17.0 | 136.1 ± 17.3 | 135.2 ± 16.9 | 135.7 ± 17.2 |
| Diastolic blood pressure, mmHg | 75.3 ± 9.8 | 75.2 ± 10.6 | 77.1 ± 9.7 | 77.3 ± 10.0 |
| Total cholesterol, mmol/le | 4.1 ± 1.0 | 4.0 ± 1.1 | 4.3 ± 1.2 | 4.2 ± 1.1 |
| LDL-cholesterol, mmol/lf | 2.1 ± 0.9 | 2.1 ± 0.9 | 2.3 ± 1.0 | 2.2 ± 0.9 |
| HDL-cholesterol, mmol/le | 1.1 ± 0.3 | 1.1 ± 0.3 | 1.2 ± 0.3 | 1.2 ± 0.3 |
| Triacylglycerol, mmol/le | 1.8 ± 1.1 | 1.9 ± 1.4 | 2.0 ± 1.6 | 1.9 ± 1.4 |
| eGFR (MDRD), ml min−1 1.73 m−2 | 69.8 ± 20.2 | 68.9 ± 20.1 | 75.6 ± 21.8 | 75.4 ± 21.1 |
| ≥90 | 183 (15.6) | 77 (13.7) | 867 (24.7) | 411 (23.2) |
| 60 to <90 | 612 (52.1) | 290 (51.5) | 1811 (51.6) | 948 (53.6) |
| <60 | 380 (32.3) | 196 (34.8) | 832 (23.7) | 411 (23.2) |
Data are n (%) or mean ± SD in participants treated with ≥1 dose of study drug
aInformation was not available for one participant in the placebo group
bInformation was not available for one participant in the placebo group and one participant in the empagliflozin group
cBased on the narrow standardised Medical Dictionary for Regulatory Activities (MedDRA) query ‘cardiac failure’
dInformation was not available for one participant in the empagliflozin group
eEmpagliflozin n = 1162 and placebo n = 555 for participants with a history of CABG; empagliflozin n = 3464 and placebo n = 1754 for participants without a history of CABG
fEmpagliflozin n = 1161 and placebo n = 555 for participants with a history of CABG; empagliflozin n = 3462 and placebo n = 1754 for participants without a history of CABG
CV, cardiovascular; n/a, not applicable