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Katakami et al. Cardiovasc Diabetol (2020) 19:110 https://doi.org/10.1186/s12933-020-01079-4 Cardiovascular Diabetology ORIGINAL INVESTIGATION Open Access Tofoglifozin does not delay progression of carotid atherosclerosis in patients with type 2 diabetes: a prospective, randomized, open-label, parallel-group comparative study Naoto Katakami1,2* , Tomoya Mita3, Hidenori Yoshii4, Toshihiko Shiraiwa5, Tetsuyuki Yasuda6, Yosuke Okada7, Keiichi Torimoto7, Yutaka Umayahara8, Hideaki Kaneto9, Takeshi Osonoi10, Tsunehiko Yamamoto11, Nobuichi Kuribayashi12, Kazuhisa Maeda13, Hiroki Yokoyama14, Keisuke Kosugi15, Kentaro Ohtoshi16, Isao Hayashi17, Satoru Sumitani18, Mamiko Tsugawa19, Kayoko Ryomoto20, Hideki Taki21, Tadashi Nakamura22, Satoshi Kawashima23, Yasunori Sato24, Hirotaka Watada3 and Iichiro Shimomura1 on behalf of the UTOPIA study investigators Abstract Background: This study aimed to investigate the preventive efects of tofoglifozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, on atherosclerosis progression in type 2 diabetes (T2DM) patients without apparent cardiovascular disease (CVD) by monitoring carotid intima-media thickness (IMT). Methods: This prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group, comparative study included 340 subjects with T2DM and no history of apparent CVD recruited at 24 clinical units. Subjects were randomly allocated to either the tofoglifozin treatment group (n 169) or conventional treatment group using drugs other than SGLT2 inhibitors (n 171). Primary outcomes were changes= in mean and maximum common carotid IMT measured by echography during= a 104-week treatment period. Results: In a mixed-efects model for repeated measures, the mean IMT of the common carotid artery (mean- IMT-CCA), along with the right and left maximum IMT of the CCA (max-IMT-CCA), signifcantly declined in both the tofoglifozin ( 0.132 mm, SE 0.007; 0.163 mm, SE 0.013; 0.170 mm, SE 0.020, respectively) and the control group ( 0.140 mm,− SE 0.006; 0.190 mm,− SE 0.012; 0.190 mm,− SE 0.020, respectively).
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