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Table 2 Effects of tofogliflozin on biomarkers of arteriosclerosis

From: Tofogliflozin long-term effects on atherosclerosis progression and major clinical parameters in patients with type 2 diabetes mellitus lacking a history of cardiovascular disease: a 2-year extension study of the UTOPIA trial

 

Observation point

Tofogliflozin group

Conventional treatment group

Intergroup p value for measurements

Treatment effect; mean intergroup difference in change (95% CI) (intergroup p value)

Measurement

Mean change

(intragroup p value)

Measurement

Mean change

(intragroup p value)

Common mean IMT-CCA (mm)

Week 0

0.873 ± 0.156

(n = 146)

 

0.870 ± 0.159

(n = 145)

 

0.89

 

Week 104

0.738 ± 0.145

(n = 145)

− 0.135 (0.007)

(p < 0.001)

0.724 ± 0.136

(n = 143)

− 0.145 (0.007)

(p < 0.001)

0.38

0.010 (− 0.010, 0.030)

(p = 0.32)

Week 208

0.807 ± 0.149

(n = 137)

− 0.067 (0.009)

(p < 0.001)

0.790 ± 0.141

(n = 129)

− 0.080 (0.009)

(p < 0.001)

0.33

0.013 (− 0.012, 0.037)

(p = 0.32)

Right maximum IMT-CCA (mm)

Week 0

1.064 ± 0.300

(n = 146)

 

1.069 ± 0.263

(n = 144)

 

0.88

 

Week 104

0.911 ± 0.305

(n = 145)

− 0.154 (0.013)

(p < 0.001)

0.879 ± 0.218

(n = 142)

− 0.188 (0.013)

(p < 0.001)

0.32

0.034 (− 0.002, 0.069)

(p = 0.06)

Week 208

1.031 ± 0.369

(n = 137)

− 0.040 (0.023)

(p = 0.09)

1.012 ± 0.338

(n = 129)

− 0.052 (0.024)

(p = 0.031)

0.67

0.012 (− 0.053, 0.078)

(p = 0.72)

Left maximum IMT-CCA (mm)

Week 0

1.148 ± 0.383

(n = 146)

 

1.127 ± 0.384

(n = 144)

 

0.65

 

Week 104

0.965 ± 0.391

(n = 145)

− 0.185 (0.021)

(p < 0.001)

0.929 ± 0.313

(n = 142)

− 0.196 (0.021)

(p < 0.001)

0.39

0.012 (− 0.048, 0.071)

(p = 0.70)

Week 208

1.099 ± 0.413

(n = 137)

− 0.053 (0.029)

(p = 0.07)

1.096 ± 0.503

(n = 129)

− 0.048 (0.029)

(p = 0.10)

0.96

− 0.005 (− 0.086, 0.076)

(p = 0.91)

Mean baPWV (cm/s)

Week 0

1706.2 ± 419.5

(n = 75)

 

1655.2 ± 319.5

(n = 65)

 

0.42

 

Week 104

1685.5 ± 352.3

(n = 72)

− 54.5 ± 235.9

(p = 0.06)

1738.6 ± 362.2

(n = 63)

56.5 ± 199.1

(p = 0.033)

0.39

− 111.0 (− 188.6, − 33.5)

(p = 0.005)

Week 208

1689.6 ± 391.2

(n = 65)

− 17.5 ± 221.3

(p = 0.54)

1774.4 ± 329.4

(n = 53)

82.7 ± 210.3

(p = 0.008)

0.21

− 100.2 (− 182.8, − 17.5)

(p = 0.018)

Mean ABI

Week 0

1.13 ± 0.10

(n = 104)

 

1.14 ± 0.08

(n = 95)

 

0.34

 

Week 104

1.14 ± 0.08

(n = 97)

0.01 ± 0.09

(p = 0.30)

1.15 ± 0.08

(n = 88)

0.00 ± 0.08

(p = 0.98)

0.65

0.01 (− 0.02, 0.04)

(p = 0.47)

Week 208

1.15 ± 0.09

(n = 88)

0.01 ± 0.09

(p = 0.17)

1.14 ± 0.10

(n = 73)

0.00 ± 0.09

(p = 0.68)

0.61

0.02 (− 0.01, 0.05)

(p = 0.22)

  1. Data are presented as the mean ± standard deviation or adjusted mean change (standard error). Comparisons of the IMT-CCA, baPWV, and ABI values during treatment with those at baseline were performed using a one-sample t-test based on the mixed-effects model for repeated measures. Intergroup differences in IMT-CCA measurements were analyzed using Student’s t-test. Intergroup differences in changes in IMT-CCA from baseline (treatment effect) were analyzed using the mixed-effects model for repeated measures. The treatment group, week, interactions between treatment group and week, age, sex, use of insulin at baseline, and baseline IMT-CCA were included as fixed effects. IMT-CCA: intima-media thickness of the common carotid artery; baPWV: brachial-ankle pulse wave velocity; ABI: ankle-brachial index; 95% CI: 95% confidence interval
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Cardiovascular Diabetology

ISSN: 1475-2840