Table 2.
Baseline characteristics and changes in parameters after 12 weeks of treatment
| Placebo (n = 25) | Empa (n = 26) | Difference between groups | |||||
|---|---|---|---|---|---|---|---|
| Baseline | Posttreatment | p | Baseline | Posttreatment | p | p | |
| Clinical parameters | |||||||
| Systolic blood pressure (mm Hg) | 124 ± 16 | 124 ± 13 | 0.9395 | 125 ± 9 | 124 ± 9 | 0.5717 | 0.7109 |
| Diastolic blood pressure (mm Hg) | 74 ± 11 | 73 ± 10 | 0.8425 | 71 ± 8 | 71 ± 10 | 0.9717 | 0.9063 |
| Weight (kg) | 93 [83;105] | 94 [82;104] | 0.8882 | 91 [81;105] | 89 [80;102] | < 0.0001 | 0.0047 |
| BMI (kg/m2) | 34.1 [30.4;39.5] | 33.2 [30.3;38.3] | 0.8851 | 32.6 [31.8;36.5] | 32 [30.6;35.3] | < 0.0001 | 0.0045 |
| Waist circumference (cm) | 113 [103;124] | 112 [102;121] | 0.2623 | 114 [103;120] | 113 [101;117] | 0.0360 | 0.4266 |
| Biological parameters | |||||||
| Fasting blood glucose (mmol/L) | 9.22 ± 2.49 | 8.74 ± 2.42 | 0.2516 | 9.59 ± 2.44 | 7.35 ± 1.73 | < 0.0001 | 0.0063 |
| HbA1c (%) | 8.1 ± 1.1 | 7.8 ± 0.9 | 0.0605 | 8.1 ± 1.0 | 7.3 ± 0.6 | < 0.0001 | 0.0033 |
| Total cholesterol (g/L) | 1.72 ± 0.40 | 1.68 ± 0.35 | 0.5340 | 1.57 ± 0.37 | 1.57 ± 0.44 | 0.8655 | 0.5111 |
| HDL-cholesterol (g/L) | 0.41 [0.32;0.45] | 0.42 [0.33;0.5] | 0.7394 | 0.40 [0.36;0.50] | 0.46 [0.38;0.53] | 0.0123 | 0.1359 |
| LDL-cholesterol (g/L) | 0.92 ± 0.25 | 0.92 ± 0.29 | 0.9668 | 0.83 ± 0.30 | 0.84 ± 0.34 | 0.6199 | 0.7940 |
| Triglycerides (g/L) | 1.56 [1.11;2.13] | 1.47 [1.01;2.35] | 0.9881 | 1.48 [0.94;1.97] | 1.27 [0.84;1.54] | 0.0451 | 0.6447 |
| Uricemia (µmol/L) | 284.6 ± 81.1 | 296.0 ± 87.8 | 0.3391 | 301.8 ± 82.3 | 265.7 ± 67.1 | 0.0052 | 0.0062 |
| Ferritinemia | 65.0 [15.0;158.9] | 60.2 [16.4;126.5] | 0.8462 | 75.7 [34.3;133.0] | 48.6 [19.9;92.3] | < 0.0001 | 0.0445 |
| hs-CRP (mg/L) | 3.7 [1.8;5.1] | 3.4 [1.7;6.1] | 0.1058 | 2.3 [1.0;5.6] | 2.3 [1;5.3] | 0.1349 | 0.2044 |
| PAI-1 (UI/L) | 41 [11;79] | 36.5 [10.2;72] | 0.3938 | 24 [15.2;39.2] | 16 [8.5;28.5] | 0.1396 | 0.4318 |
| AST (UI/L) | 23 [20;32] | 24 [18;33] | 0.6062 | 23 [20;33] | 23 [19;32] | 0.2339 | 0.1219 |
| ALT (UI/L) | 33 [23;54] | 34 [23;44] | 0.3178 | 30 [25;42] | 28 [18;44] | 0.0302 | 0.0705 |
| GGT (UI/L) | 42 [30;76] | 43 [26;63] | 0.3698 | 36 [26;47] | 28 [24;42] | 0.0002 | 0.2219 |
| Hematocrit | 0.38 [0.35;0.41] | 0.38 [0.36;0.43] | 0.5520 | 0.40 [0.37;0.43] | 0.43 [0.40;0.46] | < 0.0001 | 0.0001 |
| Reticulocytes (%) | 1.4 [1.2;1.8] | 1.5 [1.1;1.7] | 0.4463 | 1.5 [1.2;1.8] | 1.3 [1.2;1.6] | 0.0030 | 0.0027 |
| EPO (mU/mL) | 13 [8.5;18] | 11 [8.2;16.5] | 0.1709 | 8.7 [4.9;14] | 9.2 [5.9;13.7] | 0.1789 | 0.0412 |
| Glycosuria (mmol/L) | 0.75 [0.31;3.13] | 1.06 [0.36;5.72] | 0.6434 | 1.13 [0.56;12.83] | 193.3 [125.4;256.7] | < 0.0001 | < 0.0001 |
| MRI parameters | |||||||
| Ejection fraction (%) | 63.7 ± 8.3 | 63.3 ± 7.7 | 0.6598 | 63.1 ± 8.2 | 63.3 ± 7.2 | 0.8515 | 0.6515 |
| LVM (g) | 129 [107;149] | 124 [107;151] | 0.2217 | 117 [93;150] | 110 [97;142] | 0.5153 | 0.9707 |
| LVMi (g) | 64 [59;72] | 64 [57;69] | 0.1429 | 58 [51;66] | 58 [52;64] | 0.3802 | 0.9545 |
| E/A ratio | 1.26 [1.07;1.49] | 1.17 [0.85;1.44] | 0.3289 | 1.14 [0.90;1.71] | 1.08 [0.92;1.62] | 0.5619 | 0.3923 |
BMI body mass index; PAI-1 plasminogen activator inhibitor-1; EPO: erythropoietin; LVEF left ventricular ejection fraction; LVM left ventricular mass; LVMi left ventricular mass indexed to body surface area