Abstract | BACKGROUND: METHODS: The present study was a post hoc analysis based on data obtained from the Using Tofogliflozin for Possible Better Intervention against Atherosclerosis for Type 2 Diabetes Patients (UTOPIA) trial, which was a multicenter prospective, randomized, open-label, blinded-endpoint study conducted to evaluate the efficacy of tofogliflozin in preventing the progression of atherosclerosis in patients with T2DM. We evaluated the longitudinal change in the ultrasonic tissue characteristics of the carotid wall using gray-scale median (GSM), an established index of ultrasonic tissue characteristics. The right and left intima-medial areas were delineated, and the GSM values were evaluated (right GSM-CCA and left GSM-CCA). The average values of the right and left carotid arteries were defined as "mean GSM-CCA value." RESULTS: In a mixed-effects model for repeated measures, mean GSM-CCA, along with the right and left GSM-CCA values, did not significantly change in either the tofogliflozin (n = 168) or conventional treatment group (n = 169). In addition, the tofogliflozin and conventional treatment groups did not significantly differ regarding the change of the mean GSM-CCA (mean difference [95% CI] - 1.24[- 3.87, 1.38], P = 0.35), along with the right (mean difference [95% CI] - 2.33[- 5.70, 1.05], P = 0.18) and the left GSM-CCA (mean difference [95% CI] - 0.29 [- 3.53, 2.95], P = 0.86) values. Similar findings were obtained even after adjusting for traditional cardiovascular risk factors and/or the administration of drugs at baseline. CONCLUSIONS: The tissue characteristics of the carotid arterial wall did not change in either the tofogliflozin or conventional treatment group during the 104-week treatment period, and there was no significant difference between the treatment groups. Clinical trial registration UMIN000017607 ( https://www.umin.ac.jp/icdr/index.html ).
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Authors | Naoto Katakami, Tomoya Mita, Norikazu Maeda, Yasunori Sato, Hirotaka Watada, Iichiro Shimomura, UTOPIA Study Investigators |
Journal | Cardiovascular diabetology
(Cardiovasc Diabetol)
Vol. 21
Issue 1
Pg. 19
(02 05 2022)
ISSN: 1475-2840 [Electronic] England |
PMID | 35123483
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | © 2022. The Author(s). |
Chemical References |
- Benzhydryl Compounds
- Glucosides
- Sodium-Glucose Transporter 2 Inhibitors
- 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
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Topics |
- Adult
- Aged
- Benzhydryl Compounds
(adverse effects, therapeutic use)
- Carotid Arteries
(diagnostic imaging, drug effects)
- Carotid Artery Diseases
(diagnostic imaging, drug therapy)
- Carotid Intima-Media Thickness
- Diabetes Mellitus, Type 2
(diagnosis, drug therapy)
- Female
- Glucosides
(adverse effects, therapeutic use)
- Humans
- Japan
- Male
- Middle Aged
- Plaque, Atherosclerotic
- Prospective Studies
- Sodium-Glucose Transporter 2 Inhibitors
(adverse effects, therapeutic use)
- Time Factors
- Treatment Outcome
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