Table 1 Baseline characteristics in the treatment groups separately in patients with versus those without metabolic syndrome at baseline
With metabolic syndrome | Without metabolic syndrome | |||
|---|---|---|---|---|
Placebo n = 1902 | Empagliflozin n = 3838 | Placebo n = 426 | Empagliflozin n = 819 | |
Female | 546 (28.7) | 1119 (29.2) | 104 (24.4) | 228 (27.8) |
Ethnicity | ||||
White | 1423 (74.8) | 2891 (75.3) | 251 (58.9) | 491 (60.0) |
Black/African American | 101 (5.3) | 187 (4.9) | 19 (4.5) | 48 (5.9) |
Asian | 359 (18.9) | 723 (18.8) | 151 (35.4) | 276 (33.7) |
Native Hawaiian | 3 (0.2) | 5 (0.1) | 1 (0.2) | 1 (0.1) |
American Indian, Alaskan | 16 (0.8) | 31 (0.8) | 4 (0.9) | 3 (0.4) |
Missing | 0 | 1 (< 0.1) | 0 | 0 |
Age, years | 63.1 ± 8.7 | 63.1 ± 8.5 | 63.7 ± 9.1 | 63.2 ± 8.9 |
T2D duration, years | ||||
≤ 1 | 46 (2.4) | 106 (2.8) | 6 (1.4) | 21 (2.6) |
> 1 to 5 | 309 (16.2) | 579 (15.1) | 61 (14.3) | 126 (15.4) |
> 5 to 10 | 474 (24.9) | 986 (25.7) | 95 (22.3) | 186 (22.7) |
> 10 | 1073 (56.4) | 2167 (56.5) | 264 (62.0) | 486 (59.3) |
Medication | ||||
Metformina | 1415 (74.4) | 2840 (74.0) | 315 (73.9) | 599 (73.1) |
Insulina | 967 (50.8) | 1912 (49.8) | 166 (39.0) | 324 (39.6) |
Beta blocker | 1268 (66.7) | 2579 (67.2) | 227 (53.3) | 459 (56.0) |
Diuretics | 871 (45.8) | 1785 (46.5) | 116 (27.2) | 254 (31.0) |
ACEi/ARBs | 1571 (82.6) | 3200 (83.4) | 293 (68.8) | 576 (70.3) |
Statins | 1431 (75.2) | 2959 (77.1) | 338 (79.3) | 646 (78.9) |
eGFR, mL/min/1.73 m2 | 72.83 ± 21.25 | 73.12 ± 21.83 | 78.25 ± 19.66 | 78.91 ± 19.88 |
Prior stroke | 448 (23.6) | 923 (24.0) | 104 (24.4) | 155 (18.9) |
Prior CAD | 1444 (75.9) | 2901 (75.6) | 315 (73.9) | 619 (75.6) |
Prior MI | 895 (47.1) | 1799 (46.9) | 186 (43.7) | 382 (46.6) |
Prior PAD | 387 (20.3) | 813 (21.2) | 90 (21.1) | 164 (20.0) |
Heart failure | 219 (11.5) | 399 (10.4) | 25 (5.9) | 61 (7.4) |
Retinopathy | 429 (22.6) | 856 (22.3) | 93 (21.8) | 164 (20.0) |
BMI, kg/m2 | 31.65 ± 5.17 | 31.57 ± 5.19 | 26.28 ± 2.71 | 26.22 ± 2.83 |
Weight, kg | 89.46 ± 19.13 | 89.15 ± 18.83 | 74.15 ± 12.53 | 72.78 ± 12.30 |
Waist circumference, cm | 107.2 ± 13.8 | 107.0 ± 13.4 | 95.2 ± 9.6 | 94.2 ± 9.5 |
SBP, mmHg | 136.8 ± 17.4 | 136.4 ± 17.1 | 131.4 ± 16.0 | 130.0 ± 15.4 |
DBP, mmHg | 77.3 ± 10.3 | 77.2 ± 9.8 | 74.8 ± 9.3 | 73.9 ± 9.0 |
HbA1c, % | 8.10 ± 0.85 | 8.10 ± 0.85 | 7.97 ± 0.80 | 7.94 ± 0.81 |
UACR | ||||
Normal (< 30 mg/g) | 971 (51.1) | 1968 (51.3) | 407 (95.5) | 803 (98.0) |
Micro (30–300 mg/g) | 663 (34.9) | 1325 (34.5) | 12 (2.8) | 12 (1.5) |
Macro (> 300 mg/g) | 254 (13.4) | 505 (13.2) | 6 (1.4) | 4 (0.5) |
Missing | 14 (0.7) | 40 (1.0) | 1 (0.2) | 0 |
Uric acid, mg/dL | 6.11 ± 1.68 | 6.05 ± 1.67 | 5.51 ± 1.50 | 5.48 ± 1.41 |
ASAT, U/L | 23.07 ± 10.65 | 22.61 ± 9.81 | 22.05 ± 8.75 | 21.93 ± 8.69 |
ALAT, U/L | 26.74 ± 15.85 | 25.88 ± 14.01 | 24.13 ± 12.25 | 23.77 ± 12.47 |
HDL-C, mg/dL | 42.6 ± 10.8 | 43.3 ± 11.6 | 50.6 ± 11.3 | 50.5 ± 11.2 |
LDL-C, mg/dL | 85.6 ± 36.0 | 86.4 ± 36.6 | 81.6 ± 32.3 | 83.6 ± 32.4 |
Triglycerides, mg/dL | 185.8 ± 128.4 | 185.1 ± 138.1 | 103.6 ± 35.6 | 103.6 ± 31.2 |
Fufilling 2 criteriab | 730 (38.4) | 1500 (39.1) | NA | NA |
Fulfilling 3 criteriab | 661 (34.8) | 1332 (34.7) | NA | NA |
Fufilling 4 or 5 criteriab | 478 (25.1) | 936 (24.4) | NA | NA |
Not evaluable for number of fulfilled criteriac | 33 (1.7) | 77 (2.0) | NA | NA |