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Table 2 Comparison of laboratory values, 24 h urine, body weight, hemodynamics, blood pressure and echocardiography during the study

From: Empagliflozin does not change cardiac index nor systemic vascular resistance but rapidly improves left ventricular filling pressure in patients with type 2 diabetes: a randomized controlled 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

  1. 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
  2. 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
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Cardiovascular Diabetology

ISSN: 1475-2840