Table 1. Baseline Characteristics at Randomization for Participants Entering Post-trial Follow-up.
| Empagliflozin (n=2472) | Placebo (n=2419) | |
|---|---|---|
| Demographics | ||
| Age at randomization (years) | 63 (14) | 63 (14) |
| Sex | ||
| Men | 1632 (66%) | 1595 (66%) |
| Women | 840 (34%) | 824 (34%) |
| Race | ||
| White | 1552 (63%) | 1503 (62%) |
| Black | 91 (4%) | 87 (4%) |
| Asian | 791 (32%) | 791 (33%) |
| Mixed | 14 (1%) | 6 (<1%) |
| Other | 24 (1%) | 32 (1%) |
| Prior disease | ||
| Prior diabetes* | 1087 (44%) | 1020 (42%) |
| Prior cardiovascular disease§ | 639 (26%) | 641 (26%) |
| Clinical measurements | ||
| Systolic blood pressure (mmHg) | 136.9 (18.3) | 136.9 (18.3) |
| Diastolic blood pressure (mmHg) | 78.6 (11.6) | 78.6 (11.8) |
| Body mass index (kg/m2) | 29.9 (6.6) | 30.0 (6.7) |
| Laboratory measurements | ||
| eGFR (mL/min/1.73m2)† | ||
| Mean (SD) | 36.9 (14.1) | 36.9 (14.1) |
| <30 | 854 (35%) | 857 (35%) |
| ≥30 to <45 | 1128 (46%) | 1082 (45%) |
| ≥45 | 490 (20%) | 480 (20%) |
| uACR (mg/g)† | ||
| Geometric mean (approx. SE) | 212 (9) | 214 (9) |
| Median (Q1-Q3) | 324 (44-1045) | 313 (45-1079) |
| <30 | 515 (21%) | 515 (21%) |
| ≥30 to ≤300 | 686 (28%) | 677 (28%) |
| >300 | 1271 (51%) | 1227 (51%) |
| Concomitant medication use | ||
| RAS inhibitor | 2142 (87%) | 2066 (85%) |
| Any diuretic | 1028 (42%) | 1052 (43%) |
| Any lipid-lowering medication | 1638 (66%) | 1582 (65%) |
| Cause of kidney disease | ||
| Diabetic kidney disease | 727 (29%) | 677 (28%) |
| Hypertensive/renovascular disease | 553 (22%) | 572 (24%) |
| Glomerular disease | 670 (27%) | 636 (26%) |
| Other/unknown | 522 (21%) | 534 (22%) |
| 5 year predicted kidney failure risk (%) | ||
| Median (Q1-Q3) | 10 (3-29) | 10 (3-30) |
Data are n (%), mean (SD), geometric mean (approx.. SE), or median (Q1-Q3). eGFR=estimated glomerular filtration rate. uACR=urinary albumin-to-creatinine ratio. RAS=renin-angiotensin system.
*
Prior diabetes mellitus at randomization is defined as participant-reported history of diabetes of any type, use of glucose-lowering medication, or baseline HbA1c ≥48 mmol/mol at Randomization visit.
§
Prior cardiovascular disease defined as self-reported history of myocardial infarction, heart failure, stroke, transient ischemic attack, or peripheral arterial disease.
†
Uses central measurement taken at the randomization visit, or most recent local laboratory result before randomization. Those with missing data for BMI (n=12) not presented in relevant rows.