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Table 2 Posttreatment changes

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

 

Time-point

8 weeks

16 weeks

Variable

EE

E

p-value

EE

E

p value

 Heart rate, bpm

6.0 (15)

10 (17)

0.075

1.0 (14)

0.0 (7)

0.002

 Office SBP, mmHg

−6 (15)

−6 (17)

0.781

−10 (18)

−4 (20)

0.284

 Office DBP, mmHg

−5 (11)

−2 (9)

0.726

−4 (11)

−2 (13)

0.197

 Body weight, Kg

−1.8 (2.1)

−1.5 (2.2)

0.935

−2.3 (3.1)

−2.2 (3.1)

0.788

 Body Mass Index, Kg/m2

−0.7 (0.7)

−0. 6 (1.0)

0.905

−0. 8 (1.0)

−0.7 (1.3)

0.391

 Waist circumference, cm

−0.7 (0.7)

−0. 6 (1.0)

0.989

−1.3 ± 3.1

−1.6 ± 3.5

0.983

Biochemical analysis

 Hemoglobin, g/dL

0.7 (1.1)

0.5 (1.3)

0.026

0.8 (0.9)

0.75 (1.4)

0.233

 Fasting Blood Glucose, mg/dL

−38 (43)

−44 (40)

0.011

−38 (48)

−41 (44.5)

0.089

 HbA1c, %

−0.8 (0.8)

−1.0 (0.8)

0.609

−0.7 (1.0)

−0.9 (0.9)

0.824

 LDL-C, mg/dL

−41 ± 19

−5 ± 20

 < 0.001

−44 ± 18

−1.1 ± 16

 < 0.001

 HDL-C, mg/dL

0.0 (7)

0.9 (10)

0.806

−2.0 (9)

2.14 (9)

0.515

 VLDL-C, mg/dL

−7 (12)

−3 (12)

0.184

−8 (12)

−3 (15)

0.038

 Triglycerides, mg/dL

−31 (54)

−19 (67)

0.315

−39 ± 52

−28 ± 69

0.132

 Creatinine, mg/dL

0.00 (0.14)

0.03 (0.13)

0.105

−0.03 (0.13)

0.03 (0.12)

0.222

 C-Reactive Protein, mg/dL

0.02 (0.11)

0.00 (0.15)

0.172

0.01 (0.17)

0.01 (0.20)

0.957

 AST, U/L

0.00 (5.00)

0.00 (5.50)

0.014

1.0 (5.25)

1.00 (5.00)

0.003

 ALT, U/L

0.50 (6.25)

1.00 (11.00)

0.001

3.00 (6.00)

4.00 (9.00)

0.001

 Urea, mg/dL

4.00 (11.00)

4.00 (8.00)

0.010

3.00 (12.00)

3.00 (10.00)

0.010

FMD, mm

 1-min

1.97 (0.54)

0.33 (0.25)

 < 0.001

2.72 (0.93)

0.41 (0.88)

 < 0.001

 2-min

1.64 (0.45)

0.34 (0.61)

 < 0.001

2.24 (0.96)

0.32 (0.77)

 < 0.001

 3-min

1.06 (0.93)

0.10 (0.78)

 < 0.001

1.73 (1.37)

0.31 (1.06)

 < 0.001

 4-min

0.81 (1.15)

0.39 (1.17)

 < 0.001

1.18 (1.41)

0.56 (1.10)

 < 0.001

 5-min

0.29 (1.26)

0.19 (0.73)

 < 0.001

0.98 (1.37)

0.44 (0.92)

 < 0.001

 AUC

10.04 (4.60)

6.18 (4.92)

 < 0.001

12.12 (3.98)

7.28 (4.39)

 < 0.001

Blood velocity parameters

 PVS, cm/sec

  0-min

4.4 (5.6)

1.9 (4.1)

 < 0.001

15.2 (17.6)

4.1 (13.4)

0.002

  1-min

0.7 (9.9)

0.1 (5.0)

0.524

23.3 (18.4)

11.2 (12.7)

0.001

  5-min

5.6 (11.1)

4.6 (9.4)

0.484

22.1 (19.3)

11.2 (14.9)

0.019

 EDV, cm/sec

      

  0-min

0.05 (0.03)

-0.45 (0.06)

 < 0.001

0.19 (0.13)

0.87 (0.11)

 < 0.001

  1-min

0.38 (0.34)

0.05 (0.05)

 < 0.001

0.60 (0.56)

0.16 (0.17)

 < 0.001

  5-min

0.36 (0.35)

0.12 (0.13)

 < 0.001

0.06 (1.59)

0.00 (1.65)

 < 0.001

Plasma biomarkers of endothelial function

 Nitrate, nmol/L

  0-min

1.40 (10.90)

1.30 (10.52)

0.056

5.90 (16.50)

2.60 (11.80)

0.001

  1-min

4.13 (16.60)

2.45 (12.50)

0.030

9.20 (19.30)

3.90 (12.30)

0.007

  5-min

3.20 (15.98)

1.53 (11.41)

0.006

6.40 (17.80)

1.50 (12.15)

0.007

 Nitrite, nmol/L

  0-min

0.18 (0.53)

0.06 (0.63)

0.012

0.14 (0.72)

0.02 (0.74)

0.025

  1-min

0.14 (0.85)

0.03 (0.71)

0.009

0.22 (1.12)

0.02 (0.81)

0.058

  5-min

0.02 (0.57)

0.00 (0.61)

0.082

0.12 (0.76)

0.07 (0.47)

0.010

Plasma biomarkers of vascular inflammation

 Isoprostane, pg/mL

na

na

na

−1.68 (5.87)

−1.12 (5.34)

 < 0.001

 sVCAM1, ng/mL

na

na

na

−0.20 (0.85)

−0.32 (1.16)

0.524

24 h BP Monitoring

 SBP, mmHg

na

na

na

−8.0 (13)

−4 (16)

0.363

 DBP, mmHg

na

na

na

−3.0 (7.5)

−3.5 (11.25)

0.419

  1. 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; na, not available