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Table 2 Effects of tofogliflozin on gray-scale median values

From: Evaluation of the effect of tofogliflozin on the tissue characteristics of the carotid wall—a sub-analysis of the UTOPIA trial

 

Tofogliflozin group

Conventional group

Treatment effect (tofogliflozin-conventional treatment) mean change (95% CI), P value

P value between groups

Mean GSM-CCA

 Baseline

38.07 ± 12.49 (n = 168)

38.42 ± 14.19 (n = 169)

 

0.81

 Week 52

38.09 ± 12.01

39.49 ± 14.29

 

0.35

 Week 104

37.32 ± 12.86

38.63 ± 14.80

 

0.42

 Change at Week 52

− 0.38 ± 12.02

1.03 ± 11.58

− 1.40 (− 4.03, 1.23), P = 0.30

 

 Change at Week 104

− 0.98 ± 11.15

0.26 ± 11.90

− 1.24 (− 3.87, 1.38), P = 0.35

 

Right GSM-CCA

 Baseline

37.91 ± 14.36 (n = 168)

37.90 ± 15.82 (n = 169)

 

0.99

 Week 52

38.01 ± 14.21

39.37 ± 17.12

 

0.45

 Week 104

36.06 ± 13.84

38.33 ± 15.75

 

0.19

 Change at Week 52

− 0.07 ± 16.25

1.45 ± 17.47

− 1.52 (− 5.29, 2.26), P = 0.43

 

 Change at Week 104

− 1.80 ± 14.35

0.52 ± 15.22

− 2.33 (− 5.70, 1.05), P = 0.18

 

Left GSM-CCA

 Baseline

38.06 ± 13.93 (n = 166)

38.94 ± 15.44 (n = 169)

 

0.58

 Week 52

38.26 ± 13.27

39.50 ± 16.22

 

0.46

 Week 104

38.48 ± 15.24

38.84 ± 16.53

 

0.85

 Change at Week 52

− 0.40 ± 13.66

0.44 ± 13.6

− 0.85(− 3.84,2.14), P = 0.58

 

 Change at Week 104

− 0.06 ± 14.50

0.23 ± 13.81

− 0.29 (− 3.53, 2.95), P = 0.86

 

Right GSM-lesion

 Baseline

47.53 ± 25.71 (n = 99)

48.43 ± 22.65 (n = 109)

 

0.79

 Week 52

48.55 ± 26.02

48.93 ± 24.42

 

0.92

 Week 104

46.70 ± 24.00

49.92 ± 24.12

 

0.36

 Change at Week 52

1.33 ± 24.69

− 0.83 ± 25.66

2.15 (− 5.20, 9.50), P = 0.56

 

 Change at Week 104

0.37 ± 27.09

2.01 ± 28.34

− 1.64 (− 10.01, 6.73), P = 0.70

 

Left GSM-lesion

 Baseline

47.93 ± 23.29 (n = 107)

48.24 ± 23.96 (n = 111)

 

0.92

 Week 52

50.76 ± 27.66

46.30 ± 24.60

 

0.23

 Week 104

47.83 ± 22.64

47.65 ± 21.48

 

0.95

 Change at Week 52

4.31 ± 25.42

− 2.68 ± 25.85

6.99 (− 0.34, 14.32), P = 0.06

 

 Change at Week 104

1.33 ± 21.36

− 0.14 ± 22.96

1.47 (− 4.98, 7.92), P = 0.65

 

Common mean-IMT-CCA

 Baseline

0.87 ± 0.16 (n = 168)

0.86 ± 0.15 (n = 169)

 

0.93

 Week 52

0.79 ± 0.14

0.78 ± 0.13

 

0.76

 Week 104

0.74 ± 0.14

0.72 ± 0.13

 

0.48

 Change at Week 52

− 0.085 ± 0.071§

− 0.085 ± 0.067§

0.001 (− 0.012, 0.015), P = 0.84

 

 Change at Week 104

− 0.136 ± 0.091§

− 0.142 ± 0.080§

0.008 (− 0·009, 0·025), P = 0.35

 

Right mean-IMT-CCA

 Baseline

0.84 ± 0.15 (n = 168)

0.85 ± 0.15 (n = 169)

 

0.84

 Week 52

0.77 ± 0.13

0.77 ± 0.14

 

0.96

 Week 104

0.72 ± 0.13

0.72 ± 0.14

 

0.76

 Change at Week 52

− 0.074 ± 0.076§

− 0.077 ± 0.074§

0.003 (0.013, 0.018), P = 0.74

 

 Change at Week 104

− 0.124 ± 0.092§

− 0.131 ± 0.086§

0.007 (0.011, 0.025), P = 0.46

 

Left mean-IMT-CCA

 Baseline

0.89 ± 0.20 (n = 168)

0.88 ± 0.19 (n = 169)

 

0.76

 Week 52

0.80 ± 0.18

0.79 ± 0.17

 

0.66

 Week 104

0.75 ± 0.19

0.73 ± 0.17

 

0.38

 Change at week 52

− 0.096 ± 0.107§

− 0.094 ± 0.092§

0.001 (0.019, 0.020), P = 0.95

 

 Change at week 104

− 0.148 ± 0.127§

− 0.153 ± 0.107§

0.010 (0.013, 0.033), P = 0.41

 
  1. Data are presented as the mean ± SD unless stated otherwise. Comparisons of GSM values during treatment with those at baseline were performed using a one-sample t-test based on the mixed-effects model for repeated measures. *P < 0.05, #P < 0.01, §P < 0.001. Differences in GSM (or IMT) between groups at each point and delta change in GSM (or IMT) from baseline to week 52 and 104 between groups at each point (treatment effect) were analyzed using Student’s t-test
  2. CCA common carotid artery, GSM Gray-Scale Median, IMT intima-media thickness