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Table 4 Adjusted risk ratio (RR) with %95CI and adjusted risk difference (RD) with %95CI for biomarkers of fatty liver addition to sensitivity analysis via ITT approach

From: The effect of empagliflozin on non-alcoholic fatty liver disease-related parameters in patients with type 2 diabetes mellitus: a randomized controlled trial

Variable

Group

Per protocol

ITT*

Intervention (N = 69)

Control (N = 50)

RR (95%CI)

RD (95%CI)

RR (95%CI)

RD (95%CI)

Alt

Baseline

Normal

0

0

-

-

-

-

Abnormal

70

(50)

70

(50)

-

-

-

-

Month 3

Normal

8

(89)

1

(11)

-

-

-

-

Abnormal

61

(44.55)

49

(55.45)

0.90 (0.82, 0.99)

-0.10 (-0.18, -0.01)

0.16 (0.02, 1.29)

-0.10 (-0.18, -0.01)

Month 6

Normal

20

(95.24)

1

(4.76)

-

 

-

-

Abnormal

49

(50)

49

(50)

0.72 (0.62, 0.84)

-0.27 (-0.38, -0.16)

0.05 (0.006, 0.38)

-0.27 (-0.38, -0.16)

Ast

Baseline

Normal

15

(30.61)

34

(69.39)

-

-

-

-

Abnormal

54

(60)

36

(40)

-

-

-

-

Month 3

Normal

44

(58.67)

31

(41.33)

-

-

-

-

Abnormal

25

(57)

19

(43)

0.95 (0.59, 1.53)

-0.02 (-0.19, 0.15)

0.93 (0.45, 1.9)

-0.02 (-0.19, 0.15)

Month 6

Normal

59

(65.56)

31

(34.44)

-

 

-

-

Abnormal

10

(34.48)

19

(65.52)

0.38 (0.19, 0.75)

-0.24 (-0.39, -0.08)

0.28 (0.12, 0.67)

-0.23 (-0.38, -0.08)

Alkp

Baseline

Normal

7 (100)

0

-

-

-

-

Abnormal

62 (60)

50 (40)

-

-

-

-

Month 3

Normal

10 (100)

0

-

-

-

-

Abnormal

59 (54)

50 (46)

0.86 (0.77, 0.94)

-0.14 (-0.23, -0.06)

0.90 (0.88, 0.92)

-0.10 (-0.12, -0.08)

Month 6

Normal

8 (100)

0

-

-

-

-

Abnormal

61 (55)

50 (45)

0.88 (0.81, 0.96)

-0.12 (-0.19, -0.04)

0.88 (0.86, 0.91)

-0.11 (-0.14, -0.09)

GGT

Baseline

Normal

22

(31)

49

(70)

-

-

-

-

Abnormal

47

(69.12)

21

(30.38)

-

-

-

-

Month 3

Normal

49

(57)

37

(43)

-

-

-

-

Abnormal

20

(60.61)

13

(39.39)

1.11 (0.61, 2.02)

0.03 (-0.13, 0.19)

1.16 (0.51, 2.63)

0.03 (-0.13, 0.19)

Month 6

Normal

58

(61)

37

(39)

-

-

-

-

Abnormal

11

(54)

13

(46)

0.61 (0.30, 1.25)

-0.10 (-0.25, 0.05)

0.54 (0.22, 1.33)

-0.10 (-0.25, 0.05)

  1. Normal Alt for male: 29–33, for female: 19–25, Normal Ast for male: 10–40, for female: 9–32, Normal Allk.p for men: 45–115, for women: 30–100, Normal GGT for male: 8–61, for female: 5–36, *Intention-to-treat analysis using multiple imputation (N = 70 in each group)