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Table 1 Characteristics of the study population at randomization

From: Evolocumab on top of empagliflozin improves endothelial function of individuals with diabetes: randomized active-controlled trial

Variable

EE

E

p-value

n

55

55

 

Age, years

58 ± 6

58 ± 8

0.580

Gender male, %

73

69

0.821

T2D duration, years

10 (10)

9 (10)

0.181

CVD, %

6 (11)

3 (5.8)

0.841

Hypertension, %

67

76

0.538

Prior smoking habit, %

45

38

0.556

Sedentarism, %

38

36

0.876

Statin use, %

100

100

1.000

Heart rate, bpm

72 ± 10

72 ± 10

0.860

Office SBP, mmHg

135 ± 15

134 ± 14

0.783

Office DBP, mmHg

82 ± 8.4

81 ± 10

0.884

24 h SBP, mmHg

124 ± 16

127 ± 6.1

0.937

24 h DBP, mmHg

74 ± 8.7

72 ± 0.9

0.650

Body weight, Kg

87 ± 17

87 ± 15

0.902

Height, m

1.7 ± 0.1

1.7 ± 0.1

0.423

Body Mass Index, Kg/m2

31 ± 5.1

31 ± 4.2

0.800

Waist circumference, cm

105 ± 14

106 ± 15

0.343

Biochemical analysis

   

Hemoglobin, g/dL

14 ± 1.2

14 ± 1.2

0.301

Fasting Blood Glucose, mg/dL

172 (60)

167 (58)

0.917

HbA1c, %

7.8 (1.2)

8.1 (0.9)

0.583

LDL-C, mg/dL

84 ± 13

83 ± 13

0.915

HDL-C, mg/dL

41 (12)

36 (12)

0.037

VLDL-C, mg/dL

33 (22)

32 (20)

0.592

Triglycerides, mg/dL

166 (110)

163 (108)

0.507

Creatinine, mg/dL

0.9 (0.3)

0.8 (0.2)

0.205

Urea

32 (14)

32 (14)

0.822

C-Reactive Protein, mg/dL

0.2 (0.3)

0.2 (0.4)

0.706

AST, U/L

18 (7)

19 (9)

0.480

ALT, U/L

23 (11)

25 (18)

0.254

FMD, mm

   

1-min

2.50 (1.64)

2.70 (2.16)

0.156

2-min

1.75 (1.65)

1.83 (2.22)

0.797

3-min

1.12 (2.38)

1.07 (2.08)

0.988

4-min

0.37 (1.21)

0.26 (1.10)

0.720

5-min

0.00 (0.25)

0.00 (0.14)

0.468

AUC

3.87 (5.620

5.08 (5.87)

0.862

Blood velocity parameters

   

PSV

   

0-min

73.35 (27.70)

78.43 (30.80)

0.879

1-min

79.44 (28.90)

81.98 (31.20)

0.988

5-min

72.75 (27.50)

73.57 (24.20)

0.940

EDV

   

0-min

4.75 (3.20)

4.34 (5.40)

0.556

1-min

6.39 (4.90)

5.36 (4.90)

0.593

5-min

3.36 (3.50)

3.97 (4.00)

0.517

Plasma biomarkers of endothelial function

   

Nitrate

   

0-min

26.70 (13.20)

27.60 (13.40)

0.085

1-min

27.30 (12.60)

27.00 (11.10)

0.505

5-min

26.40 (12.00)

25.70 (11.10)

0.393

Nitrite

   

0-min

0.65 (1.84)

0.65 (1.64)

0.722

1-min

0.84 (1.60)

0.78 (1.74)

0.820

5-min

0.81 (1.43)

0.91 (1.47)

0.582

Plasma biomarkers of vascular inflammation

   

Isoprostane, pg/mL

15.65 (6.13)

15.22 (5.41)

0.176

sVCAM1, ng/mL

411.65 (0.60)

411.80 (0.90)

0.709

  1. T2D, type 2 diabetes mellitus; CVD, cardiovascular disease; SBP, systolic blood pressure; DBP, diastolic blood pressure; HbA1c, glycosylated hemoglobin; LDL-C, low-density lipoprotein cholesterol; HDL-C, high-density lipoprotein cholesterol; VLDL, very low-density lipoprotein cholesterol; AST, aspartate transaminase; ALT, alanine transaminase; FMD, flow-mediated dilation; PSV, peak systolic velocity; EDV, end-diastolic velocity; sVCAM1, soluble vascular cell adhesion molecule 1