TABLE 1.
Baseline characteristics of patients included in the background population and the EMPA-REG OUTCOME trial.
| Characteristic | Background population (N = 6355) | EMPA-REG OUTCOME trial total population (N = 7020) | |
|---|---|---|---|
| Placebo (N = 2333) | Treatment (N = 4687) | ||
| Age (years) | 61.0 (9.0) | 63.2 (8.8) | 63.1 (8.6) |
| Female, N (%) | 2128 (33.5) | 653 (28.0) | 1351 (28.8) |
| Race, N (%) | |||
| Caucasian | 3529 (55.5) | 1678 (71.9) | 3403 (72.6) |
| Black | 569 (9.0) | 120 (5.1) | 237 (5.1) |
| Asian | 1527 (24.0) | 511 (21.9) | 1006 (21.4) |
| Others | 730 (11.5) | 24 (1.0) | 41 (0.9) |
| eGFR (ml/min/1.73m2) | 49.8 (23.3) | 73.8 (21.1) | 74.2 (21.6) |
| Glycated hemoglobin (%) | 8.1 (1.7) | 8.1 (0.8) | 8.1 (0.9) |
| Systolic BP (mmHg) | 144.8 (20.0) | 135.8 (17.2) | 135.3 (16.9) |
| UACR (mg/g) | 276.9 (54.5, 1193.9) | 17.7 (7.1, 74.3) | 17.7 (7.1, 71.6) |
| Weight (kg) | 83.4 (19.8) | 86.6 (19.1) | 86.2 (18.9) |
| Hemoglobin (g/L) | 128 (18.7) | 137.2 (14.8) | 137.3 (14.7) |
| HDL-cholesterol (mmol/L) | 1.2 (0.4) | 1.1 (0.3) | 1.2 (0.3) |
| LDL-cholesterol (mmol/L) | 3.1 (1.3) | 2.2 (0.9) | 2.2 (0.9) |
| Uric acid (umol/L) | 404.6 (105.7) | 359.0 (99.5) | 356.0 (98.0) |
| Potassium (mmol/L) | 4.6 (0.5) | 4.6 (0.5) | 4.5 (0.5) |
For numerical variables which are normally distributed, data is presented as mean (SD). For UACR, with a skewed distribution, median (IQR) is presented. Categorical variables are presented as frequency (%). BP, blood pressure; UACR, urinary-albumin-creatinine-ratio; HDL, high-density-lipoprotein; LDL, low-density-lipoprotein. Estimated glomerular filtration rate (eGFR) was estimated according to the Modification of Diet in Renal Disease (MDRD) formula as per the EMPA-REG OUTCOME trial protocol.