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. 2021 Jan 7;20:6. doi: 10.1186/s12933-020-01175-5

Table 2.

Comparison of laboratory values, 24 h urine, body weight, hemodynamics, blood pressure and echocardiography during the study

Baseline Day 1 Day 3 Month 3
Placebo Empagliflozin p Placebo Empagliflozin p Placebo Empagliflozin p Placebo Empagliflozin p
Laboratory
 Glucose—mg/dL 175 ± 52 181 ± 75 0.742 171 ± 48 152 ± 38 0.049 166 ± 52 146 ± 35 0.037 156 ± 52 151 ± 42 0.754
 HbA1c—% 7.9 ± 1.3 7.5 ± 0.9 0.228 7.9 ± 1.3 7.4 ± 0.9 0.722 7.9 ± 1.2 7.4 ± 0.9 0.690 7.8 ± 1.5 7.1 ± 0.7 0.595
 Total cholesterol—mg/dL 155 ± 39 169 ± 41 0.257 155 ± 37 174 ± 43 0.178 152 ± 40 168 ± 39 0.824 152 ± 42 185 ± 48 0.001
 LDL-C—mg/dL 95 ± 38 103 ± 36 0.522 94 ± 36 102 ± 36 0.915 93 ± 39 102 ± 40 0.477 89 ± 39 112 ± 47  < 0.001
 HDL-C—mg/dL 44 ± 9 43 ± 9 0.530 44 ± 9 42 ± 10 0.947 44 ± 9 43 ± 9 0.900 46 ± 11 46 ± 10 0.937
 eGFR—mL/min/1.73 m2 88 ± 16 77 ± 21 0.076 85 ± 16 70 ± 19 0.014 85 ± 17 70 ± 21 0.039 85 ± 16 68 ± 20 0.108
 Cystatin C—mg/L 1.0 ± 0.2 1.2 ± 0.4 0.148 1.0 ± 0.2 1.3 ± 0.4  < 0.001 1.0 ± 0.2 1.3 ± 0.4 0.001 1.0 ± 0.2 1.3 ± 0.4  < 0.001
 NT-proBNP—pg/mL 166 (73–238) 239 (91–463) 0.481 168 (67–252) 192 (63–385) 0.224 147 (58–226) 173 (57–402) 0.408 158 (42–262) 133 (32–500) 0.723
 Aldosterone—pg/mL 83 ± 33 104 ± 65 0.213 88 ± 32 111 ± 67 0.825 96 ± 50 108 ± 59 0.635 108 ± 71 137 ± 104 0.522
24 h urine
 Urinary volume—mL/24 h 1788 ± 756 1740 ± 601 0.829 1626 ± 681 2112 ± 837 0.011 2007 ± 913 2111 ± 758 0.429 1664 ± 594 2319 ± 873 0.001
 Glucose excretion—g/24 h 10.9 ± 22.7 7.3 ± 22.7 0.617 6.9 ± 14.1 48.4 ± 34.7 < 0.001 7.5 ± 14.5 65.7 ± 43.3 < 0.001 10.2 ± 18.7 67.6 ± 50.9 < 0.001
 Sodium excretion—mmol/24 h 196 ± 84 164 ± 88 0.255 181 ± 76 185 ± 111 0.223 203 ± 107 181 ± 126 0.970 175 ± 55 201 ± 145 0.054
 Electrolyte-free water clearance—mL/24 h − 15 ± 721 166 ± 830 0.467 − 124 ± 654 417 ± 802 0.011 90 ± 874 461 ± 551 0.070 − 91 ± 597 380 ± 765 0.013
Body weight—kg 94.0 ± 14.0 95.8 ± 17.3 0.724 94.1 ± 14.1 94.9 ± 17.0 0.044 94.0 ± 14.1 94.5 ± 17.2 0.007 93.7 ± 14.3 96.0 ± 19.6 0.059
 Hemodynamics
  CI—L/min/m2 3.2 ± 0.6 3.2 ± 0.6 0.682 3.1 ± 0.5 3.1 ± 0.5 0.771 3.1 ± 0.5 3.0 ± 0.6 0.293 3.1 ± 0.5 3.1 ± 0.5 0.303
  SVI—mL/b/m2 50 ± 7 47 ± 7 0.266 48 ± 8 45 ± 8 0.344 48 ± 8 44 ± 8 0.131 47 ± 7 47 ± 7 0.879
  SVRI—dyne*s*cm−5*m−2 1836 ± 361 1841 ± 379 0.967 1942 ± 355 1864 ± 373 0.411 1831 ± 310 1837 ± 376 0.991 1909 ± 428 1908 ± 451 0.795
  HR—bpm 66 ± 13 68 ± 12 0.665 65 ± 11 69 ± 13 0.122 66 ± 11 68 ± 14 0.717 66 ± 11 67 ± 10 0.393
 Blood pressure
  Systolic—mmHg 136 ± 18 135 ± 16 0.934 134 ± 16 128 ± 16 0.279 133 ± 19 125 ± 16 0.115 132 ± 20 128 ± 15 0.318
  Diastolic—mmHg 81 ± 14 82 ± 13 0.964 80 ± 13 80 ± 11 0.876 80 ± 12 80 ± 9 0.925 82 ± 11 79 ± 11 0.197
 Echocardiography
  LV-EF—% 48 ± 6.8 51 ± 5.0 0.183 48 ± 6.2 51 ± 4.6 0.852 48 ± 6.1 51 ± 4.7 0.333 48 ± 6.4 51 ± 4.4 0.375
  LVEDD—mm 50 ± 5 49 ± 5 0.365 50 ± 6 49 ± 5 0.864 49 ± 5 48 ± 5 0.449 50 ± 6 48 ± 6 0.994
  LVESD—mm 36 ± 8 34 ± 6 0.386 36 ± 9 35 ± 5 0.595 35 ± 8 34 ± 5 0.187 37 ± 8 33 ± 6 0.284
  IVSd—mm 10 ± 2 10 ± 1 0.940 10 ± 2 11 ± 2 0.764 10 ± 2 11 ± 2 0.630 10 ± 2 10 ± 1 0.497
  LV mass index—g/m2 91 ± 21 86 ± 19 0.474 94 ± 24 87 ± 19 0.448 90 ± 21 84 ± 19 0.701 89 ± 23 84 ± 17 0.807
  LA area—cm2 20 ± 4.2 20 ± 3.7 0.484 20 ± 5.3 18 ± 4.3 0.082 20 ± 5.7 19 ± 4.8 0.691 20 ± 4.1 18 ± 4.0 0.503
  LA volume index—mL/m2 31 ± 11 28 ± 9 0.414 30 ± 13 26 ± 10 0.300 30 ± 13 28 ± 10 0.840 31 ± 12 26 ± 9 0.239
  E—m/s 0.78 ± 0.14 0.80 ± 0.20 0.686 0.80 ± 0.12 0.73 ± 0.20 0.003 0.78 ± 0.11 0.72 ± 0.18 0.005 0.78 ± 0.13 0.72 ± 0.21 0.001
  A—m/s 0.73 ± 0.17 0.82 ± 0.17 0.095 0.74 ± 0.20 0.81 ± 0.15 0.786 0.75 ± 0.19 0.80 ± 0.15 0.550 0.73 ± 0.20 0.83 ± 0.15 0.927
  E/A 1.18 ± 0.53 0.97 ± 0.22 0.121 1.20 ± 0.55 0.88 ± 0.20 0.042 1.16 ± 0.58 0.89 ± 0.23 0.181 1.21 ± 0.52 0.85 ± 0.23 0.038
  eʹ septal—cm/s 7.2 ± 1.7 7.5 ± 1.9 0.603 6.6 ± 2.0 7.8 ± 2.1 0.077 7.2 ± 1.6 7.5 ± 2.0 0.785 7.2 ± 1.6 7.8 ± 2.1 0.470
  eʹ lateral—cm/s 9.8 ± 2.0 10.4 ± 1.8 0.319 9.6 ± 2.4 10.1 ± 2.4 0.970 9.5 ± 1.9 9.8 ± 2.3 0.840 9.3 ± 2.0 10.4 ± 2.9 0.262
  eʹ mean 8.5 ± 1.5 8.9 ± 1.6 0.361 8.1 ± 1.8 8.9 ± 2.1 0.352 8.4 ± 1.3 8.7 ± 2.0 0.968 8.3 ± 1.5 9.1 ± 2.3 0.280
  E/eʹ mean 9.3 ± 2.2 9.2 ± 2.6 0.898 10.1 ± 1.4 8.5 ± 2.2 0.005 9.5 ± 1.5 8.5 ± 2.4 0.079 9.7 ± 1.9 8.3 ± 2.9 0.004
  DT—msec 198 ± 54 206 ± 45 0.610 189 ± 45 212 ± 35 0.234 202 ± 54 215 ± 43 0.624 196 ± 59 218 ± 59 0.261
  RVSP—mmHg + CVP 28 ± 6 29 ± 4 0.515 26 ± 5 26 ± 6 0.827 25 ± 4 29 ± 10 0.261 27 ± 8 26 ± 11 0.632
  GLS (endocardial layer) − 17 ± 5.3 − 19 ± 4.1 0.107 − 17 ± 4.8 − 19 ± 3.4 0.877 − 17 ± 4.4 − 19 ± 3.7 0.735 − 17 ± 4.6 − 19 ± 2.7 0.608

Values are mean ± SD for normally distributed data and median and interquartile range for non-normally distributed data; p-values at baseline were calculated using t test, the p-value for NT-proBNP was assessed by Kruskal–Wallis test; p-values for the intervention effect at day 1, day 3 and month 3 were calculated using the Wald method, eʹ mean is the mean of eʹ septal and eʹ lateral; p-values ≤ 0.05 were categorized as statistically significant

bpm beats per min, CI cardiac index, CVP central venous pressure, DT deceleration time, eGFR estimated glomerular filtration rate, GLS global longitudinal strain, HDL-C high density lipoprotein cholesterol, HR heart rate, IVSd interventricular septum in diastole, LA left atrial, LDL-C low density lipoprotein cholesterol, LV left ventricular, LVEDD left ventricular enddiastolic diameter, LV-EF left ventricular ejection fraction, LVESD left ventricular endsystolic diameter, RVSP right ventricular systolic pressure, SVI stroke volume index, SVRI systemic vascular resistance index