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Table 2 Changes in efficacy measures

From: The effect of empagliflozin on growth differentiation factor 15 in patients with heart failure: a randomized controlled trial (Empire HF Biomarker)

 

Empagliflozin, 10 mg/day

Placebo

p value

Outcome measurements

   

GDF-15 (pg/mL)

   

Baseline

1188 (918 to 1720)

1299 (952 to 1823)

 

At 12 weeks

1394 (970 to 1942)

1271 (879 to 1872)

 

Change over 12 weeks

124 (– 27 to 297)

12 (– 87 to 156)

 

Adjusted between group treatment effecta

1.09 (1.03 to 1.15)

0.0040

hsCRP (mg/L)

   

Baseline

1.82 (0.96 to 3.70)

1.24 (0.66 to 3.40)

 

At 12 weeks

2.00 (1.13 to 3.50)

1.43 (0.83 to 3.05)

 

Change over 12 weeks

0.20 (– 0.30 to 1.20)

0.05 (– 0.50 to 0.50)

 

Adjusted between group treatment effecta

1.09 (0.86 to 1.38)

0.48

hsTNT (ng/L)

   

Baseline

12.90 (10.10 to 18.30)

14.20 (9.22 to 19.00)

 

At 12 weeks

13.40 (9.79 to 17.60)

13.10 (9.25 to 17.90)

 

Change over 12 weeks

0.33 (– 0.90 to 1.00)

– 0.10 (– 1.26 to 1.03)

 

Adjusted between group treatment effecta

1.07 (0.98 to 1.19)

0.18

Related measurements

   

Cardiac

   

LVESV (mL)

   

Baseline

108.09 (52.04)

102.43 (45.05)

 

At 12 weeks

99.98 (45.52)

101.90 (44.55)

 

Change over 12 weeks

– 8.50 (26.45)

0.01 (31.32)

 

Adjusted between group treatment effect

– 8.79 (– 17.39 to – 0.19)

0.045

Metabolic

   

BMI (kg/m2)

   

Baseline

28.94 (26.48 to 32.42)

28.27 (25.86 to 32.96)

 

At 12 weeks

28.68 (26.28 to 31.97)

28.78 (26.04 to 32.64)

 

Change over 12 weeks

– 0.33 (– 0.69 to – 0.03)

0.15 (− 0.35 to 0.48)

 

Adjusted between group treatment effecta

– 0.37 (– 0.57 to – 0.18)

 < 0.0001

Renal

   

Plasma volume (mL)

   

Baseline

3032.59 (404.59)

3175.05 (456.44)

 

At 12 weeks

2897.51 (383.44)

3177.65 (415.58)

 

Change over 12 weeks

– 135.08 (135.69)

7.7 (144.25)

 

Adjusted between group treatment effect

– 115.04 (– 152.15 to – 77.93)

 < 0.0001

  1. Median values with interquartile range are represented for variables with skewed data
  2. GDF-15 growth/differentiation factor 15, hsCRP high sensitive C-reactive protein, HsTNT high-sensitivity troponin T, LVESV left ventricular end-systolic volume, BMI body mass index
  3. aPresent the between-group treatment effect as a ratio of change. Adjusted for age, sex, and type 2 diabetes