Table 1.
Demographic and baseline characteristics of the pooled analysis population with eGFR <60 mL/min/1.73 m2 (N = 2,367)
| CKD category and study treatment | ||||||
|---|---|---|---|---|---|---|
| G3A | G3B | G4 | ||||
| Characteristic | Placebo | EMPA 10/25 mg | Placebo | EMPA 10/25 mg | Placebo | EMPA 10/25 mg |
| Patients, n | 519 | 1,003 | 277 | 445 | 52 | 71 |
| Male sex, n (%) | 358 (69.0) | 653 (65.1) | 167 (60.3) | 277 (62.2) | 30 (57.7) | 41 (57.7) |
| Age (years), mean ± SD | 67.1 ± 8.1 | 67.1 ± 7.5 | 67.9 ± 8.2 | 67.7 ± 8.7 | 63.7 ± 10.7 | 68.8 ± 9.1 |
| Race,* n (%) | ||||||
| White | 369 (71.1) | 730 (72.8) | 195 (70.4) | 308 (69.2) | 24 (46.2) | 47 (66.2) |
| Asian | 118 (22.7) | 210 (20.9) | 70 (25.3) | 109 (24.5) | 28 (53.8) | 22 (31.0) |
| Black or African American | 29 (5.6) | 52 (5.2) | 8 (2.9) | 24 (5.4) | 0 | 1 (1.4) |
| Ethnicity, n (%) | ||||||
| Not Hispanic or Latino | 450 (86.7) | 864 (86.1) | 245 (88.4) | 384 (86.3) | 50 (96.2) | 65 (91.5) |
| Hispanic or Latino | 68 (13.1) | 138 (13.8) | 33 (11.6) | 61 (13.7) | 2 (3.8) | 6 (8.5) |
| HbA1c, mean ± SD | ||||||
| % | 8.0 ± 0.8 | 8.01 ± 0.8 | 8.1 ± 0.9 | 8.1 ± 0.9 | 8.1 ± 0.9 | 7.95 ± 0.91 |
| mmol/mol | 64 ± 9 | 64 ± 9 | 65 ± 10 | 65 ± 10 | 65 ± 10 | 63 ± 10 |
| BMI (kg/m2), mean ± SD | 30.6 ± 5.2 | 31.0 ± 5.5 | 31.1 ± 5.8 | 31.3 ± 5.6 | 30.9 ± 5.7 | 29.5 ± 4.9 |
| Blood pressure (mmHg),† mean ± SD | ||||||
| Systolic | 136.7 ± 18.7 | 135.9 ± 17.1 | 135.0 ± 17.7 | 137.4 ± 18.0 | 143.0 ± 23.9 | 137.5 ± 21.0 |
| Diastolic | 75.4 ± 10.2 | 75.5 ± 10.1 | 73.6 ± 10.2 | 74.0 ± 9.9 | 75.2 ± 12.4 | 72.6 ± 10.8 |
| Heart failure,‡ n (%) | 51 (9.8) | 114 (11.4) | 31 (11.2) | 53 (11.9) | 8 (15.4) | 7 (9.9) |
| Hypertension, n (%) | 486 (93.6) | 950 (94.7) | 270 (97.5) | 426 (95.7) | 51 (98.1) | 68 (95.8) |
| Concomitant medications, n (%) | ||||||
| Metformin | 352 (67.8) | 662 (66.0) | 118 (42.6) | 198 (44.5) | 9 (17.3) | 35 (49.3) |
| Insulin | 268 (51.6) | 502 (50.0) | 172 (62.1) | 276 (62.0) | 38 (73.1) | 53 (74.6) |
| ACE inhibitors/ARBs | 424 (81.7) | 843 (84.0) | 224 (80.9) | 361 (81.1) | 36 (69.2) | 51 (71.8) |
| Loop diuretics | 109 (21) | 195 (19.4) | 91 (32.9) | 151 (33.9) | 24 (46.2) | 35 (49.3) |
| Statins | 370 (71.3) | 752 (75.0) | 198 (71.5) | 315 (70.8) | 40 (76.9) | 52 (73.2) |
| Aspirin | 387 (74.6) | 739 (73.7) | 209 (75.5) | 333 (74.8) | 34 (65.4) | 51 (71.8) |
CKD categories by eGFR: G3A, 45 to <60 mL/min/1.73 m2; G3B, 30 to <45 mL/min/1.73 m2; G4, 15 to <30 mL/min/1.73 m2. ARB, angiotensin receptor blocker; EMPA 10/25, empagliflozin 10 or 25 mg.
*
Race identified as other (American Indian, Alaska Native, Hawaiian, Pacific Islander) or race information not recorded for seven patients in the CKD category G3A group.
†
Baseline systolic/diastolic blood pressure readings were missing for one patient in the empagliflozin 10 mg group.
‡
A history of heart failure at baseline was identified by narrow standardized MedDRA query 20000004.