Table 1: Baseline characteristics in the total population in the EMPA-REG OUTCOME study.
| Empagliflozin (10 mg and 25 mg pooled) n=4,687 | Placebo n=2,333 | |
|---|---|---|
| Mean age; years (SD) | 63.1 (± 8.6) | 63.2 (± 8.8) |
| Male, n (%) | 3,336 (71.2) | 1,680 (72.0) |
| Race, n (%) | ||
| White | 3,403 (72.6) | 1,678 (71.9) |
| Asian | 1,006 (21.5) | 511 (21.9) |
| Black/African-American | 237 (5.1) | 120 (5.1) |
| Other/missing | 41 (0.9) | 24 (1.0) |
| Ethnicity n (%) | ||
| Not Hispanic or Latino | 3,835 (81.8) | 1,912 (82.0) |
| Hispanic or Latino | 847 (18.1) | 418 (17.9) |
| Missing | 5 (0.1) | 3 (0.1) |
| Region, n (%) | ||
| Europe | 1,926 (41.1) | 959 (41.1) |
| North America, Australia and New Zealand | 932 (19.9) | 462 (19.8) |
| Asia | 897 (19.1) | 450 (19.3) |
| Latin America | 721 (15.4) | 360 (15.4) |
| Africa | 211 (4.5) | 102 (4.4) |
| Weight; kg (SD) | 86.2 (± 18.9) | 86.6 (± 19.1) |
| Body mass index; kg/m2 (SD) | 30.6 (± 5.3) | 30.7 (± 5.2) |
| CV risk factor, n (%) | 4,657 (99.4) | 2,307 (98.9) |
| Coronary artery disease | 3,545 (75.6) | 1,763 (75.6) |
| Multi-vessel coronary artery disease | 2,179 (46.5) | 1,100 (47.1) |
| History of myocardial infarction | 22,190 (46.7) | 1,083 (46.4) |
| Coronary artery bypass graft | 1,175 (25.1) | 563 (24.1) |
| History of stroke | 1,084 (23.1) | 553 (23.7) |
| Peripheral artery disease | 982 (21.0) | 479 (20.5) |
| Single vessel coronary artery disease* | 498 (10.6) | 238 (10.2) |
| Cardiac failure | 462 (9.9) | 244 (10.5) |
| Glycosylated haemoglobin % (SD) | 8.07 (± 0.85) | 8.08 (± 0.84) |
| Time since diagnosis of type 2 diabetes, n (%) | ||
| ≤1 years | 128 (2.7) | 52 (2.2) |
| >1–5 years | 712 (15.2) | 371 (15.9) |
| >5–10 | 1,175 (25.1) | 571 (24.5) |
| >10 years | 2,672 (57.0) | 1,339 (57.4) |
| Glucose-lowering therapy, n (%) Medication taken alone or in combination | ||
| Metformin | 3,459 (73.8) | 1,734 (74.3) |
| Insulin | 2,252 (48.0) | 1,135 (48.6) |
| Median daily dose, IU | 54.0 | 52.0 |
| Sulfonylurea | 2,014 (43.0) | 992 (42.5) |
| Dipeptidyl peptidase-4 inhibitor | 529 (11.3) | 267 (11.4) |
| Thiazolidinedione | 198 (4.2) | 101 (4.3) |
| Glucagon-like peptide-1 agonist | 126 (2.7) | 70 (3.0) |
| Monotherapy | 1,380 (29.4) | 691 (29.6) |
| Dual therapy | 2,259 (48.2) | 1,148 (49.2) |
| Anti-hypertensive therapy, n (%) | 4,446 (94.9) | 2,221 (95.2) |
| ACE/angiotensin receptor blockers | 3,798 (81.0) | 1,868 (80.1) |
| Beta-blockers | 3,056 (65.2) | 1,498 (64.2) |
| Diuretics | 2,047 (43.7) | 988 (42.3) |
| Calcium channel blockers | 1,529 (32.6) | 788 (33.8) |
| Mineralocorticoid receptor antagonists | 305 (6.5) | 136 (5.8) |
| Renin inhibitors | 27 (0.6) | 19 (0.8) |
| Other | 383 (8.2) | 191 (8.2) |
| Lipid-lowering therapy, n (%) | 3,820 (81.5) | 1,864 (79.9) |
| Statins | 3,630 (77.4) | 1,773 (76.0) |
| Fibrates | 431 (9.2) | 199 (8.5) |
| Ezetimibe | 189 (4.0) | 81 (3.5) |
| Niacin | 91 (1.9) | 35 (1.5) |
| Other | 365 (7.8) | 175 (7.5) |
| Anti-coagulants, n (%) | 4,162 (88.8) | 2,090 (89.6) |
| Acetylsalicylic acid | 3,876 (82.7) | 1,927 (82.6) |
| Clopidogrel | 494 (10.5) | 249 (10.7) |
| Vitamin K antagonists | 266 (5.7) | 156 (6.7) |
| Systolic blood pressure mmHg (SD) | 135.3 (± 16.9) | 135.8 (± 17.2) |
| Diastolic blood pressure mmHg (SD) | 76.6 (± 9.7) | 76.8 (± 10.1) |
| Total cholesterol mg/dL (SD) | 163.5 (± 44.2) | 161.9 (± 43.1) |
| Low density lipoprotein cholesterol mg/dL (SD) | 85.9 (± 36.0) | 84.9 (± 35.3) |
| High density lipoprotein cholesterol mg/dL (SD) | 44.6 (± 11.9) | 44.0 (± 11.3) |
| Triglycerides mg/dL (SD) | 170.5 (± 129.7) | 170.7 (± 121.2) |
| Estimated GFR rate mL/min/1.73 m2 (SD) | 74.2 (± 21.6) | 73.8 (± 21.1) |
| Estimated GFR, n (%) | ||
| ≥90 mL/min/1.73 m2 | 1,050 (22.4) | 488 (20.9) |
| 60–<90 mL/min/1.73 m2 | 2,423 (51.7) | 1,238 (53.1) |
| <60 mL/min/1.73 m2 | 1,212 (25.9) | 607 (26.0) |
| Urine albumin-creatinine ratio, n (%) | ||
| <30 mg/g | 2,789 (59.5) | 1,382 (59.2) |
| 30–300 mg/g | 1,338 (28.5) | 675 (28.9) |
| >300 mg/g | 509 (10.9) | 260 (11.1) |
Reproduced with permission from Zinman et al., 2015.14 ACE = angiotensin-converting enzyme inhibitors; CV = cardiovascular; GFR = glomerular filtration rate; IU = international units; SD = standard deviation.