Table 2.
Effect of empagliflozin 10 mg/day compared to placebo on biomarkers of cardiac function, cardiac structure, circulation, metabolism and hematology after 1 and 12 weeks of intervention in individuals with type 2 diabetes mellitus
| After 1 week of treatment | After 12 weeks of treatment | |||
|---|---|---|---|---|
| Beta-estimate (95% CI) | P-value | Beta-estimate (95% CI) | P-value | |
| Cardiac biomarkers | ||||
| Left ventricular ejection fractiona [%] | 0.4 (– 0.8; 1.6) | 0.48 | – 0.3 (– 1.5; 0.9) | 0.62 |
| Left ventricular end-diastolic volumea [ml] | – 3.1 (– 8.1; 1.9) | 0.23 | 1.1 (– 4.9; 7.1) | 0.71 |
| Left ventricular mass index [g/m2.7] | – 3.9 (– 9.9; 2.1) | 0.20 | – 0.8 (– 7.3; 5.8) | 0.82 |
| Relative wall thickness | – 0.005 (– 0.029; 0.02) | 0.72 | 0.00351 (– 0.023; 0.0301) | 0.80 |
| NT-proBNPa [pg/ml] | – 0.23 (– 0.30; – 0.06) | 0.009 | – 0.01 (– 0.195; 0.175) | 0.91 |
| Troponina [pg/ml] | 0.09 (– 0.05; 0.22) | 0.21 | – 0.071 (– 0.188; 0.0458) | 0.24 |
| Circulation | ||||
| Blood pressure—Systolic [mmHg] | – 4.53 (– 8.13; – 0.92) | 0.015 | – 3.39 (– 7.37; 0.60) | 0.098 |
| Diastolic [mmHg] | – 3.05 (– 5.05; – 1.05) | 0.0034 | – 1.38 (– 3.35; 0.582) | 0.17 |
| Heart rate [bpm] | – 0.53 (– 2.63; 1.57) | 0.62 | – 0.16 (– 3.23; 2.92) | 0.92 |
| Metabolic biomarkers | ||||
| Body mass index [kg/m2] | – 0.42 (– 0.59; – 0.24) | < 0.0001 | – 0.71 (– 0.99; – 0.44) | < 0.0001 |
| C-reactive proteina [mg/L] | 0.787 (– 0.122; 0.279) | 0.44 | – 0.185 (– 0.459; 0.089) | 0.19 |
| Fatty liver index | – 0.516 (– 2.45; 1.29) | 0.55 | – 2.12 (– 4.81; 0.564) | 0.12 |
| HbA1c [%] | – 0.001 (– 0.072; 0.069) | 0.97 | – 0.43 (– 0.62; – 0.23) | < 0.0001 |
| Uric acid [mg/dL] | – 1.01 (– 1.28; – 0.75) | < 0.0001 | – 0.66 (– 1.01; – 2.96) | 0.0005 |
| Hematological biomarkers | ||||
| Leukocyte count [/nL] | 0.39 (0.05; 0.72) | 0.027 | – 0.19 (– 0.58; 0.20) | 0.34 |
| Red blood cell count [/pL] | 0.11 (0.04; 0.17) | 0.002 | 0.29 (0.20; 0.38) | < 0.0001 |
| Hemoglobin [g/dL] | 0.24 (0.06; 0.42) | 0.01 | 0.82 (0.55; 1.09) | < 0.0001 |
| Mean corpuscular hemoglobin [pg] | – 0.21 (– 0.42; – 0.004) | 0.048 | – 0.13 (– 0.40; 0.14) | 0.34 |
| Mean corpuscular hemoglobin concentration [g/L] | – 0.28 (– 0.52; – 0.04) | 0.026 | – 0.36 (– 0.61; – 0.12) | 0.005 |
| Mean corpuscular volume [fL] | 0.02 (– 0.36; 0.40) | 0.92 | 0.50 (– 0.13; 1.12) | 0.12 |
| Hematocrit [%] | 1.05 (0.45; 1.65) | 0.0009 | 2.91 (2.09; 3.73) | < 0.0001 |
| Thrombocyte count [/nL] | 8.99 (1.22; 16.8) | 0.025 | – 5.34 (– 13.6; 2.94) | 0.21 |
Linear regression with adjustment for age, sex, and baseline value of the dependent variable (as indicated in the left column) at the baseline visit; dependent variable: endpoint after 1 week and 12 weeks of treatment, respectively. Displayed is the beta-estimate with accompanying 95% confidence interval and P-value for the effect of empagliflozin 10 mg/day vs. placebo. NT-proBNP, Troponin, C-reactive protein were analyzed as dependent variable after logarithmic transformation
CI confidence interval
aPre-specified secondary endpoint