Table 1.
Demographics and baseline characteristics (all trials)
| Characteristic | Placebo (n = 3835) | Empagliflozin 10 mg (n = 3629) | Empagliflozin 25 mg (n = 3828) | Pooled empagliflozin (n = 7457) |
|---|---|---|---|---|
| Male, n (%) | 2450 (63.9) | 2366 (65.2) | 2513 (65.6) | 4879 (65.4) |
| Age, years | 61.0 ± 9.8 | 60.9 ± 9.6 | 61.2 ± 9.7 | 61.0 ± 9.6 |
| Race, n (%) | ||||
| White | 2493 (65.0) | 2417 (66.6) | 2513 (65.6) | 4930 (66.1) |
| Asian | 1133 (29.5) | 1029 (28.4) | 1113 (29.1) | 2142 (28.7) |
| Black/African American | 171 (4.5) | 155 (4.3) | 166 (4.3) | 321 (4.3) |
| Other1/missing | 38 (1.0) | 28 (0.8) | 36 (0.9) | 64 (0.9) |
| Time since diagnosis, n (%) | ||||
| ≤1 year | 167 (4.4) | 207 (5.7) | 198 (5.2) | 405 (5.4) |
| >1‐5 years | 739 (19.3) | 667 (18.4) | 695 (18.2) | 1362 (18.3) |
| >5‐10 years | 920 (24.0) | 867 (23.9) | 940 (24.6) | 1807 (24.2) |
| >10 years | 1839 (48.0) | 1719 (47.4) | 1840 (48.1) | 3559 (47.7) |
| Missing | 170 (4.4) | 169 (4.7) | 155 (4.0) | 324 (4.3) |
| Weight, kg | 85.1 ± 19.6 | 85.3 ± 19.4 | 85.5 ± 19.5 | 85.4 ± 19.5 |
| BMI, kg/m2 | 30.5 ± 5.5 | 30.5 ± 5.4 | 30.5 ± 5.5 | 30.5 ± 5.5 |
| BMI ≥30 kg/m2, n (%) | 1936 (50.5) | 1829 (50.4) | 1944 (50.8) | 3773 (50.6) |
| HbA1c, mmol/mol | 64.9 ± 9.2 | 64.8 ± 9.3 | 64.6 ± 9.2 | 64.7 ± 9.2 |
| HbA1c, % | 8.1 ± 0.8 | 8.1 ± 0.9 | 8.1 ± 0.8 | 8.1 ± 0.8 |
| SBP, mm Hg | 134.1 ± 17.0 | 133.6 ± 16.4 | 134.0 ± 16.8 | 133.8 ± 16.6 |
| DBP, mm Hg | 77.1 ± 9.8 | 77.3 ± 9.6 | 77.1 ± 9.4 | 77.2 ± 9.5 |
| eGFR, mL/min/1.73 m2 | 75.6 ± 22.6 | 78.1 ± 21.9 | 75.9 ± 23.1 | 77.0 ± 22.5 |
| Smoking status, n (%) | ||||
| Smoker | 497 (13.0) | 488 (13.4) | 488 (12.7) | 976 (13.1) |
| Ex‐smoker | 1426 (37.2) | 1366 (37.6) | 1453 (38.0) | 2819 (37.8) |
| Never smoked | 1912 (49.9) | 1775 (48.9) | 1887 (49.3) | 3662 (49.1) |
| Medical history2, n (%) | ||||
| Hypertension | 3168 (82.6) | 2973 (81.9) | 3149 (82.3) | 6122 (82.1) |
| Coronary artery disease | 2051 (53.5) | 1993 (54.9) | 2036 (53.2) | 4029 (54.0) |
| Peripheral artery occlusive disease | 539 (14.1) | 517 (14.2) | 572 (14.9) | 1089 (14.6) |
| Cerebrovascular disease | 685 (17.9) | 653 (18.0) | 692 (18.1) | 1345 (18.0) |
| Dyslipidemia3, n (%) | 1038 (27.1) | 975 (26.9) | 1008 (26.3) | 1983 (26.6) |
| Antihypertensive therapies, n (%) | 3201 (83.5) | 3031 (83.5) | 3205 (83.7) | 6236 (83.6) |
| Lipid‐lowering drugs, n (%) | 2583 (67.4) | 2524 (69.6) | 2611 (68.2) | 5135 (68.9) |
| Acetylsalicylic acid, n (%) | 2521 (65.7) | 2444 (67.3) | 2510 (65.6) | 4954 (66.4) |
Values are mean ± SD, unless otherwise stated. T2DM, type 2 diabetes mellitus; BMI, body mass index; HbA1c, glycosylated haemoglobin; FPG, fasting plasma glucose; DBP, diastolic blood pressure; SBP, systolic blood pressure; eGFR, estimated glomerular filtration rate by Modification of Diet in Renal Disease (MDRD) equation; MedDRA, Medical Dictionary for Regulatory Activities.
1
American Indian/Alaska Native/Native Hawaiian or other Pacific Islander.
2
Within 6 months prior to informed consent.
3
Concomitant diagnosis at baseline (MedDRA preferred term “dyslipidaemia”).