TABLE 1.
Baseline characteristics of patients included in the background dataset and in the LEADER trial.
| Characteristic | Background population (N = 6,355) | Total population in the LEADER trial (N = 9,340) | |
|---|---|---|---|
| Placebo (N = 4,672) | Treatment (N = 4,668) | ||
| Age (years) | 61.0 (9.0) | 68.4 (7.2) | 64.2 (7.2) |
| Female, n (%) | 2,128 (33.5) | 1,680 (36.0) | 1,657 (35.5) |
| Race, n (%) | |||
| Caucasian | 3,529 (55.5) | 3,622 (77.5) | 3,616 (77.5) |
| Black | 569 (9.0) | 407 (8.7) | 370 (7.9) |
| Asian | 1,527 (24.0) | 465 (10.0) | 471 (10.1) |
| Others | 730 (11.5) | 178 (3.8) | 211 (4.5) |
| eGFR (ml/min/1.73m2) | 51.2 (22.5) | 79.3 (21.8) | 78.9 (22.4) |
| Glycated hemoglobin (%) | 8.1 (1.7) | 8.7 (1.5) | 8.7 (1.6) |
| Systolic BP (mmHg) | 144.8 (20.0) | 135.9 (17.7) | 135.9 (17.8) |
| UACR (mg/g) | 276.9 [54.5, 1193.9] | 26.2 [7.2, 156.6] | 23.3 [7.0, 134.4] |
| Weight (kg) | 83.4 (19.8) | 91.6 (20.8) | 91.9 (21.2) |
| Hemoglobin (g/L) | 128 (18.7) | 137.1 (14.8) | 137.1 (15.3) |
| HDL-cholesterol (mmol/L) | 1.2 (0.4) | 1.2 (0.3) | 1.2 (0.3) |
| LDL-cholesterol (mmol/L) | 3.1 (1.3) | 2.3 (0.9) | 2.3 (0.9) |
| Potassium (mmol/L) | 4.6 (0.5) | 4.5 (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 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula which is in accordance to the LEADER trial protocol (Levey et al., 2009; Marso et al., 2016a).