Table 1.
Baseline characteristics (overall population)
| TRS‐HFDM category | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Very‐high risk (≥3 points) | High risk (2 points) | Low‐intermediate risk (0/1 point) | |||||||
| Placebo (n = 600) | Pooled empagliflozin (n = 1116) | Total (N = 1716) | Placebo (n = 575) | Pooled empagliflozin (n = 1232) | Total (N = 1807) | Placebo (n = 1142) | Pooled empagliflozin (n = 2287) | Total (N = 3429) | |
| Age, years | 65.2 ± 8.5 | 65.6 ± 8.3 | 65.5 ± 8.4 | 64.6 ± 8.8 | 64.2 ± 8.5 | 64.3 ± 8.6 | 61.6 ± 8.6 | 61.3 ± 8.4 | 61.4 ± 8.5 |
| Male | 451 (75.2) | 821 (73.6) | 1272 (74.1) | 421 (73.2) | 901 (73.1) | 1322 (73.2) | 795 (69.6) | 1574 (68.8) | 2369 (69.1) |
| White race | 436 (72.7) | 824 (73.8) | 1260 (73.4) | 416 (72.3) | 876 (71.1) | 1292 (71.5) | 813 (71.2) | 1660 (72.6) | 2473 (72.1) |
| Body mass index, kg/m2 | 31.2 ± 5.3 | 31.1 ± 5.4 | 31.1 ± 5.4 | 31.0 ± 5.3 | 30.6 ± 5.2 | 30.7 ± 5.3 | 30.2 ± 5.1 | 30.3 ± 5.2 | 30.3 ± 5.2 |
| >10 years since diagnosis of diabetes | 392 (65.3) | 711 (63.7) | 1103 (64.3) | 358 (62.3) | 766 (62.2) | 1124 (62.2) | 581 (50.9) | 1166 (51.0) | 1747 (50.9) |
| HbA1c, % | 8.1 ± 0.9 | 8.1 ± 0.9 | 8.1 ± 0.9 | 8.1 ± 0.8 | 8.2 ± 0.9 | 8.1 ± 0.9 | 8.1 ± 0.8 | 8.0 ± 0.8 | 8.0 ± 0.8 |
| Baseline insulin use | 374 (62.3) | 640 (57.3) | 1014 (59.1) | 286 (49.7) | 642 (52.1) | 928 (51.4) | 466 (40.8) | 943 (41.2) | 1409 (41.1) |
| Baseline sulphonylurea use | 221 (36.8) | 445 (39.9) | 666 (38.8) | 248 (43.1) | 525 (42.6) | 773 (42.8) | 516 (45.2) | 1023 (44.7) | 1539 (44.9) |
| Diabetic retinopathy | 191 (31.8) | 312 (28.0) | 503 (29.3) | 125 (21.7) | 292 (23.7) | 417 (23.1) | 203 (17.8) | 402 (17.6) | 605 (17.6) |
| eGFR, mL/min/1.73m2 | 61.3 ± 19.1 | 60.8 ± 19.7 | 61.0 ± 19.5 | 69.5 ± 21.3 | 70.2 ± 21.3 | 70.0 ± 21.3 | 82.5 ± 17.6 | 82.8 ± 18.4 | 82.7 ± 18.2 |
| Baseline eGFR < 60 mL/min/1.73m2 | 349 (58.2) | 658 (59.0) | 1007 (58.7) | 209 (36.3) | 449 (36.4) | 658 (36.4) | 45 (3.9) | 93 (4.1) | 138 (4.0) |
| UACR | |||||||||
| Normal | 139 (23.2) | 269 (24.1) | 408 (23.8) | 213 (37.0) | 430 (34.9) | 643 (35.6) | 1030 (90.2) | 2090 (91.4) | 3120 (91.0) |
| Microalbuminuria | 240 (40.0) | 419 (37.5) | 659 (38.4) | 323 (56.2) | 721 (58.5) | 1044 (57.8) | 112 (9.8) | 197 (8.6) | 309 (9.0) |
| Macroalbuminuria | 221 (36.8) | 428 (38.4) | 649 (37.8) | 39 (6.8) | 81 (6.6) | 120 (6.6) | 0 | 0 | 0 |
| CV disease | |||||||||
| CAD† | 542 (90.3) | 999 (89.5) | 1541 (89.8) | 486 (84.5) | 1027 (83.4) | 1513 (83.7) | 723 (63.3) | 1478 (64.6) | 2201 (64.2) |
| Myocardial infarction | 355 (59.2) | 653 (58.5) | 1008 (58.7) | 266 (46.3) | 601 (48.8) | 867 (48.0) | 458 (40.1) | 911 (39.8) | 1369 (39.9) |
| Peripheral artery disease | 128 (21.3) | 254 (22.8) | 382 (22.3) | 101 (17.6) | 243 (19.7) | 344 (19.0) | 247 (21.6) | 475 (20.8) | 722 (21.1) |
| Stroke | 122 (20.3) | 207 (18.5) | 329 (19.2) | 104 (18.1) | 246 (20.0) | 350 (19.4) | 325 (28.5) | 617 (27.0) | 942 (27.5) |
| Atrial fibrillation | 101 (16.8) | 173 (15.5) | 274 (16.0) | 26 (4.5) | 51 (4.1) | 77 (4.3) | 15 (1.3) | 18 (0.8) | 33 (1.0) |
| Multivessel CAD | 341 (56.8) | 635 (56.9) | 976 (56.9) | 321 (55.8) | 646 (52.4) | 967 (53.5) | 428 (37.5) | 871 (38.1) | 1299 (37.9) |
| Hypertension | 573 (95.5) | 1070 (95.9) | 1643 (95.7) | 539 (93.7) | 1144 (92.9) | 1683 (93.1) | 1027 (89.9) | 2006 (87.7) | 3033 (88.5) |
| Current smoker | 76 (12.7) | 120 (10.8) | 196 (11.4) | 77 (13.4) | 139 (11.3) | 216 (12.0) | 147 (12.9) | 359 (15.7) | 506 (14.8) |
| Systolic blood pressure, mmHg | 137.6 ± 19.0 | 138.3 ± 18.0 | 138.1 ± 18.4 | 137.9 ± 17.4 | 136.7 ± 17.3 | 137.1 ± 17.3 | 133.9 ± 15.9 | 132.9 ± 15.8 | 133.2 ± 15.8 |
| Diastolic blood pressure, mmHg | 76.4 ± 10.5 | 76.3 ± 10.2 | 76.3 ± 10.3 | 76.9 ± 10.9 | 76.6 ± 9.9 | 76.7 ± 10.2 | 77.1 ± 9.6 | 76.8 ± 9.4 | 76.9 ± 9.5 |
Abbreviations: CAD, coronary artery disease; CV, cardiovascular; eGFR, estimated glomerular filtration rate; HbA1c, glycated haemoglobin; TRS‐HFDM, Thrombolysis In Myocardial Infarction Risk Score for Heart Failure in Diabetes; UACR, urine albumin‐to‐creatinine ratio.
†
CAD was defined as any of the components of a history of myocardial infarction, coronary artery bypass graft, single vessel CAD or multivessel CAD.
Note: Data are n (%) or mean ± SD.