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
© 2023. The Author(s)..
BACKGROUND: This study aimed to assess the long-term effects of tofogliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on atherosclerosis progression and major clinical parameters in patients with type 2 diabetes lacking an apparent history of cardiovascular disease.
METHODS: This was a prospective observational 2-year extension study of the "Using TOfogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA)" trial, a 2-year randomized intervention study. The primary endpoints represented changes in the carotid intima-media thickness (IMT). Secondary endpoints included brachial-ankle pulse wave velocity (baPWV) and biomarkers for glucose metabolism, lipid metabolism, renal function, and cardiovascular risks.
RESULTS: The mean IMT of the common carotid artery (IMT-CCA) significantly decreased in both the tofogliflozin (- 0.067 mm, standard error 0.009, p < 0.001) and conventional treatment groups (- 0.080 mm, SE 0.009, p < 0.001) throughout the follow-up period; however, no significant intergroup differences in the changes (0.013 mm, 95% confidence interval (CI) - 0.012 to 0.037, p = 0.32) were observed in a mixed-effects model for repeated measures. baPWV significantly increased in the conventional treatment group (82.7 ± 210.3 cm/s, p = 0.008) but not in the tofogliflozin group (- 17.5 ± 221.3 cm/s, p = 0.54), resulting in a significant intergroup difference in changes (- 100.2 cm/s, 95% CI - 182.8 to - 17.5, p = 0.018). Compared to the conventional treatment group, tofogliflozin significantly improved the hemoglobin A1c and high-density lipoprotein cholesterol levels, body mass index, abdominal circumference, and systolic blood pressure. The frequencies of total and serious adverse events did not vary significantly between the groups.
CONCLUSIONS: Tofogliflozin was not associated with improved inhibition of carotid wall thickening but exerted long-term positive effects on various cardiovascular risk factors and baPWV while showing a good safety profile.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
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| Enthalten in: |
Cardiovascular diabetology - 22(2023), 1 vom: 22. Juni, Seite 143 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Katakami, Naoto [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 26.06.2023 Date Revised 22.11.2023 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1186/s12933-023-01879-4 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM358511135 |
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| 100 | 1 | |a Katakami, Naoto |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Tofogliflozin long-term effects on atherosclerosis progression and major clinical parameters in patients with type 2 diabetes mellitus lacking a history of cardiovascular disease |b a 2-year extension study of the UTOPIA trial |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 26.06.2023 | ||
| 500 | |a Date Revised 22.11.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a BACKGROUND: This study aimed to assess the long-term effects of tofogliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on atherosclerosis progression and major clinical parameters in patients with type 2 diabetes lacking an apparent history of cardiovascular disease | ||
| 520 | |a METHODS: This was a prospective observational 2-year extension study of the "Using TOfogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA)" trial, a 2-year randomized intervention study. The primary endpoints represented changes in the carotid intima-media thickness (IMT). Secondary endpoints included brachial-ankle pulse wave velocity (baPWV) and biomarkers for glucose metabolism, lipid metabolism, renal function, and cardiovascular risks | ||
| 520 | |a RESULTS: The mean IMT of the common carotid artery (IMT-CCA) significantly decreased in both the tofogliflozin (- 0.067 mm, standard error 0.009, p < 0.001) and conventional treatment groups (- 0.080 mm, SE 0.009, p < 0.001) throughout the follow-up period; however, no significant intergroup differences in the changes (0.013 mm, 95% confidence interval (CI) - 0.012 to 0.037, p = 0.32) were observed in a mixed-effects model for repeated measures. baPWV significantly increased in the conventional treatment group (82.7 ± 210.3 cm/s, p = 0.008) but not in the tofogliflozin group (- 17.5 ± 221.3 cm/s, p = 0.54), resulting in a significant intergroup difference in changes (- 100.2 cm/s, 95% CI - 182.8 to - 17.5, p = 0.018). Compared to the conventional treatment group, tofogliflozin significantly improved the hemoglobin A1c and high-density lipoprotein cholesterol levels, body mass index, abdominal circumference, and systolic blood pressure. The frequencies of total and serious adverse events did not vary significantly between the groups | ||
| 520 | |a CONCLUSIONS: Tofogliflozin was not associated with improved inhibition of carotid wall thickening but exerted long-term positive effects on various cardiovascular risk factors and baPWV while showing a good safety profile | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Atherosclerosis | |
| 650 | 4 | |a Brachial-ankle pulse wave velocity | |
| 650 | 4 | |a Cardiovascular risk factors | |
| 650 | 4 | |a Carotid intima-media thickness | |
| 650 | 4 | |a Sodium-glucose cotransporter 2 inhibitor | |
| 650 | 4 | |a Tofogliflozin | |
| 650 | 7 | |a 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol |2 NLM | |
| 650 | 7 | |a P8DD8KX4O4 |2 NLM | |
| 700 | 1 | |a Mita, Tomoya |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshii, Hidenori |e verfasserin |4 aut | |
| 700 | 1 | |a Shiraiwa, Toshihiko |e verfasserin |4 aut | |
| 700 | 1 | |a Yasuda, Tetsuyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Okada, Yosuke |e verfasserin |4 aut | |
| 700 | 1 | |a Kurozumi, Akira |e verfasserin |4 aut | |
| 700 | 1 | |a Hatazaki, Masahiro |e verfasserin |4 aut | |
| 700 | 1 | |a Kaneto, Hideaki |e verfasserin |4 aut | |
| 700 | 1 | |a Osonoi, Takeshi |e verfasserin |4 aut | |
| 700 | 1 | |a Yamamoto, Tsunehiko |e verfasserin |4 aut | |
| 700 | 1 | |a Kuribayashi, Nobuichi |e verfasserin |4 aut | |
| 700 | 1 | |a Maeda, Kazuhisa |e verfasserin |4 aut | |
| 700 | 1 | |a Yokoyama, Hiroki |e verfasserin |4 aut | |
| 700 | 1 | |a Kosugi, Keisuke |e verfasserin |4 aut | |
| 700 | 1 | |a Ohtoshi, Kentaro |e verfasserin |4 aut | |
| 700 | 1 | |a Hayashi, Isao |e verfasserin |4 aut | |
| 700 | 1 | |a Sumitani, Satoru |e verfasserin |4 aut | |
| 700 | 1 | |a Tsugawa, Mamiko |e verfasserin |4 aut | |
| 700 | 1 | |a Ryomoto, Kayoko |e verfasserin |4 aut | |
| 700 | 1 | |a Kato, Ken |e verfasserin |4 aut | |
| 700 | 1 | |a Nakamura, Tadashi |e verfasserin |4 aut | |
| 700 | 1 | |a Kawashima, Satoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Sato, Yasunori |e verfasserin |4 aut | |
| 700 | 1 | |a Watada, Hirotaka |e verfasserin |4 aut | |
| 700 | 1 | |a Shimomura, Iichiro |e verfasserin |4 aut | |
| 700 | 0 | |a UTOPIA study investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Komiyama, K |e investigator |4 oth | |
| 700 | 1 | |a Shimizu, T |e investigator |4 oth | |
| 700 | 1 | |a Kamei, S |e investigator |4 oth | |
| 700 | 1 | |a Kinoshita, T |e investigator |4 oth | |
| 700 | 1 | |a Shimoda, M |e investigator |4 oth | |
| 700 | 1 | |a Saito, M |e investigator |4 oth | |
| 700 | 1 | |a Fujiki, N |e investigator |4 oth | |
| 700 | 1 | |a Fujita, Y |e investigator |4 oth | |
| 700 | 1 | |a Shimizu, S |e investigator |4 oth | |
| 700 | 1 | |a Umayahara, Y |e investigator |4 oth | |
| 700 | 1 | |a Irie, Y |e investigator |4 oth | |
| 700 | 1 | |a Kataoka, R |e investigator |4 oth | |
| 700 | 1 | |a Kiyohara, Y |e investigator |4 oth | |
| 700 | 1 | |a Ohashi, M |e investigator |4 oth | |
| 700 | 1 | |a Ryomoto, K |e investigator |4 oth | |
| 700 | 1 | |a Takahi, Y |e investigator |4 oth | |
| 700 | 1 | |a Fujishima, Y |e investigator |4 oth | |
| 700 | 1 | |a Fujita, Y |e investigator |4 oth | |
| 700 | 1 | |a Fukuhara, A |e investigator |4 oth | |
| 700 | 1 | |a Fukui, K |e investigator |4 oth | |
| 700 | 1 | |a Hosokawa, Y |e investigator |4 oth | |
| 700 | 1 | |a Imagawa, A |e investigator |4 oth | |
| 700 | 1 | |a Iwahashi, H |e investigator |4 oth | |
| 700 | 1 | |a Mukai, K |e investigator |4 oth | |
| 700 | 1 | |a Katsura, T |e investigator |4 oth | |
| 700 | 1 | |a Kawamori, D |e investigator |4 oth | |
| 700 | 1 | |a Kimura, T |e investigator |4 oth | |
| 700 | 1 | |a Kobayashi, S |e investigator |4 oth | |
| 700 | 1 | |a Kozawa, J |e investigator |4 oth | |
| 700 | 1 | |a Kubo, F |e investigator |4 oth | |
| 700 | 1 | |a Maeda, N |e investigator |4 oth | |
| 700 | 1 | |a Matsuoka, T |e investigator |4 oth | |
| 700 | 1 | |a Miyashita, K |e investigator |4 oth | |
| 700 | 1 | |a Nakata, S |e investigator |4 oth | |
| 700 | 1 | |a Ninomiya, H |e investigator |4 oth | |
| 700 | 1 | |a Nishizawa, H |e investigator |4 oth | |
| 700 | 1 | |a Okuno, Y |e investigator |4 oth | |
| 700 | 1 | |a Otsuki, M |e investigator |4 oth | |
| 700 | 1 | |a Sakamoto, F |e investigator |4 oth | |
| 700 | 1 | |a Sasaki, S |e investigator |4 oth | |
| 700 | 1 | |a Sato, I |e investigator |4 oth | |
| 700 | 1 | |a Shimo, N |e investigator |4 oth | |
| 700 | 1 | |a Shimomura, I |e investigator |4 oth | |
| 700 | 1 | |a Takahara, M |e investigator |4 oth | |
| 700 | 1 | |a Takano, T |e investigator |4 oth | |
| 700 | 1 | |a Tokunaga, A |e investigator |4 oth | |
| 700 | 1 | |a Uno, S |e investigator |4 oth | |
| 700 | 1 | |a Yamaoka, M |e investigator |4 oth | |
| 700 | 1 | |a Yoneda, S |e investigator |4 oth | |
| 700 | 1 | |a Hajime, M |e investigator |4 oth | |
| 700 | 1 | |a Koikawa, K |e investigator |4 oth | |
| 700 | 1 | |a Kuno, F |e investigator |4 oth | |
| 700 | 1 | |a Matsushita, K |e investigator |4 oth | |
| 700 | 1 | |a Narisawa, M |e investigator |4 oth | |
| 700 | 1 | |a Tanaka, K |e investigator |4 oth | |
| 700 | 1 | |a Sugai, K |e investigator |4 oth | |
| 700 | 1 | |a Torimoto, K |e investigator |4 oth | |
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