Table 1 Patient baseline characteristics.
Placebo n = 62 | Empagliflozin n = 62 | P value | |
---|---|---|---|
Male sex, n (%) | 37 (59.7) | 40 (64.5) | 0.579 |
Patients with isolated systolic hypertension, n (%) | 17 (27.4) | 14 (22.5) | 0.534 |
Age, years | 71.7 ± 4.3 | 71.2 ± 4.0 | 0.560 |
BMI, kg/m2 | 25.8 ± 2.3 | 25.5 ± 2.3 | 0.565 |
eGFR, mL/min/1.73 m2 | 81.5 ± 8.6 | 83.0 ± 7.0 | 0.285 |
HbA1c, % | 7.7 ± 1.1 | 7.7 ± 0.5 | 0.887 |
FPG, mmol/L | 8.6 ± 1.0 | 8.4 ± 0.8 | 0.252 |
Years since diagnosis of type 2 diabetes, n (%) | |||
≤ 1 | 7 (11.3) | 8 (12.9) | 0.064 |
> 1 to 5 | 19 (30.6) | 11 (17.7) | |
> 5 to 10 | 22 (35.5) | 16 (25.8) | |
> 10 | 14 (22.6) | 27 (43.5) | |
SBP (office measurement), mmHg | 159.5 ± 8.0 | 157.1 ± 10.1 | 0.151 |
SBP (mean over 24 h), mmHg | 150.8 ± 37.2 | 153.0 ± 36.8 | 0.384 |
DBP (office measurement), mmHg | 97.7 ± 4.7 | 98.5 ± 2.0 | 0.278 |
DBP (mean over 24 h), mmHg | 95.4 ± 22.3 | 96.2 ± 23.4 | 0.171 |
Pulse rate (mean 24 h), bpm | 77.8 ± 5.2 | 77.3 ± 8.2 | 0.705 |
Serum insulin (uU/mL) | 14.2 ± 2.9 | 14.4 ± 3.7 | 0.704 |
HOMA-IR | 5.5 ± 1.4 | 5.4 ± 1.5 | 0.828 |
FMD (%) | 7.1 ± 1.0 | 7.0 ± 1.0 | 0.289 |
cPWV(m/s) | 6.7 ± 1.4 | 6.4 ± 0.8 | 0.085 |
Antihypertensive drugs | |||
Diuretic drugs | 10 (16.1) | 12 (19.4) | 0.638 |
Calcium channel blockers | 25 (40.3) | 29 (46.8) | 0.469 |
ACEI/ARB | 43 (69.4) | 45 (72.6) | 0.692 |
β-blockers | 27 (43.5) | 32 (51.6) | 0.369 |
Anti-diabetic drugs | |||
Insulin | 7 (11.3) | 11 (17.7) | 0.308 |
Sulfonylurea | 14 (22.6) | 19 (30.6) | 0.310 |
DPP4 inhibitor | 27 (43.5) | 31 (50.0) | 0.472 |
Metformin | 47 (75.8) | 43 (69.4) | 0.421 |
Lipid-lowering agents | |||
Statins | 45 (72.6) | 50 (80.6) | 0.289 |
Fibrates | 13 (21.0) | 19 (30.6) | 0.218 |
Patients with BP ≥ 130/80 mmHg (ABPM) at baseline, Mean 24-h SBP | 186.1 ± 21.4 | 189.5 ± 21.6 | 0.895 |
Patients with BP ≥ 130/80 mmHg (ABPM) at baseline, mean 24-h DBP | 114.7 ± 23.9 | 116.1 ± 24.1 | 0.571 |
Patients with BP < 130/80 mmHg (ABPM) at baseline, mean 24-h SBP | 123.5 ± 5.7 | 121.0 ± 8.1 | 0.366 |
Patients with BP < 130/80 mmHg (ABPM) at baseline, mean 24-h DBP | 71.7 ± 6.9 | 72.5 ± 5.2 | 0.277 |