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.

Humans Cardiovascular Diseases / diagnosis Ankle Brachial Index Carotid Intima-Media Thickness Diabetes Mellitus, Type 2 / complications Pulse Wave Analysis Utopias Atherosclerosis
Atherosclerosis Brachial-ankle pulse wave velocity Cardiovascular risk factors Carotid intima-media thickness Sodium-glucose cotransporter 2 inhibitor Tofogliflozin

Journal

Cardiovascular diabetology
ISSN: 1475-2840
Titre abrégé: Cardiovasc Diabetol
Pays: England
ID NLM: 101147637

Informations de publication

Date de publication:
22 06 2023
Historique:
received: 27 03 2023
accepted: 05 06 2023
medline: 26 6 2023
pubmed: 23 6 2023
entrez: 22 6 2023
Statut: epublish

Résumé

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. 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. 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. 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.

Sections du résumé

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.

Identifiants

DOI: 10.1186/s12933-023-01879-4 PMID: 37349722 PMC: PMC10286339
pubmed: 37349722
doi: 10.1186/s12933-023-01879-4
pii: 10.1186/s12933-023-01879-4
pmc: PMC10286339
doi:

Substances chimiques

6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol P8DD8KX4O4

Types de publication

Randomized Controlled Trial Observational Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

143

Investigateurs

K Komiyama (K)
T Shimizu (T)
S Kamei (S)
T Kinoshita (T)
M Shimoda (M)
M Saito (M)
N Fujiki (N)
Y Fujita (Y)
S Shimizu (S)
Y Umayahara (Y)
Y Irie (Y)
R Kataoka (R)
Y Kiyohara (Y)
M Ohashi (M)
K Ryomoto (K)
Y Takahi (Y)
Y Fujishima (Y)
Y Fujita (Y)
A Fukuhara (A)
K Fukui (K)
Y Hosokawa (Y)
A Imagawa (A)
H Iwahashi (H)
K Mukai (K)
T Katsura (T)
D Kawamori (D)
T Kimura (T)
S Kobayashi (S)
J Kozawa (J)
F Kubo (F)
N Maeda (N)
T Matsuoka (T)
K Miyashita (K)
S Nakata (S)
H Ninomiya (H)
H Nishizawa (H)
Y Okuno (Y)
M Otsuki (M)
F Sakamoto (F)
S Sasaki (S)
I Sato (I)
N Shimo (N)
I Shimomura (I)
M Takahara (M)
T Takano (T)
A Tokunaga (A)
S Uno (S)
M Yamaoka (M)
S Yoneda (S)
M Hajime (M)
K Koikawa (K)
F Kuno (F)
K Matsushita (K)
M Narisawa (M)
K Tanaka (K)
K Sugai (K)
K Torimoto (K)

Informations de copyright

© 2023. The Author(s).

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Auteurs

Naoto Katakami (N)

Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. katakami@endmet.med.osaka-u.ac.jp.
Department of Metabolism and Atherosclerosis, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. katakami@endmet.med.osaka-u.ac.jp.

Tomoya Mita (T)

Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.

Hidenori Yoshii (H)

Department of Medicine, Diabetology & Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Koto-ku, Tokyo, 136-0075, Japan.

Toshihiko Shiraiwa (T)

Shiraiwa Medical Clinic, 4-10-24 Hozenji, Kashiwara, Osaka, 582-0005, Japan.

Tetsuyuki Yasuda (T)

Department of Endocrinology and Metabolism, Osaka Police Hospital, 10-31, Kitayama-Cho, Tennoji-ku, Osaka, 543-0035, Japan.

Yosuke Okada (Y)

First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.

Akira Kurozumi (A)

First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.

Masahiro Hatazaki (M)

Department of Diabetes and Endocrinology, Osaka General Medical Center, 3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka, 558-8558, Japan.

Hideaki Kaneto (H)

Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.

Takeshi Osonoi (T)

Nakakinen Clinic, 745-5, Nakadai, Naka, Ibaraki, 311-0113, Japan.

Tsunehiko Yamamoto (T)

Diabetes and Endocrinology, Kansai Rosai Hospital, 3-1-69, Inabaso, Amagasaki, Hyogo, Japan.

Nobuichi Kuribayashi (N)

Misaki Naika Clinic, 6-44-9, Futawa-Higashi, Funabashi, Chiba, Japan.

Kazuhisa Maeda (K)

Kitasenri Maeda Clinic, 4-119, Furuedai, Suita, Osaka, 565-0874, Japan.

Hiroki Yokoyama (H)

Jiyugaoka Medical Clinic, West 6, South 6-4-3, Obihiro, Hokkaido, 080-0016, Japan.

Keisuke Kosugi (K)

Kosugi Medical Clinic, 3-9, Tamatsukurimoto-Cho, Tennoji-ku, Osaka, 543-0014, Japan.

Kentaro Ohtoshi (K)

Otoshi Medical Clinic, 8-47, KakudachoOsaka Kita-ku, Osaka, 530-0017, Japan.

Isao Hayashi (I)

Hayashi Clinic, 3-9-23, Koshienguchi, Nishinomiya, Hyogo, 663-8113, Japan.

Satoru Sumitani (S)

Center for Diabetes and Endocrinology, Nippon Life Hospital, 2-1-54 Enokojima, Nishi-ku, Osaka, 550-0006, Japan.
Department of Diabetology and Endocrinology, Pref Osaka Saiseikai Izuo Hospital, 3-4-5 Kitamura, Taisho, Osaka, 551-0032, Japan.

Mamiko Tsugawa (M)

Department of Endocrinology and Metabolism, Ikeda Municipal Hospital, 3-1-18, Jonan, Ikeda, Osaka, 563-8510, Japan.
Department of Diabetes and Endocrinology, Meiwa Hospital, 4-31 Agenaruo, Nishinomiya, Hyogo, 663-8186, Japan.

Kayoko Ryomoto (K)

Center for Diabetes Mellitus, Osaka Rosai Hospital, 1179-3 Nagasone-Cho, Kita-ku, Sakai, Osaka, 591-8025, Japan.

Ken Kato (K)

Diabetes Center, National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.

Tadashi Nakamura (T)

Department of Internal Medicine, Kawasaki Hospital, 3-3-1, Higashiyamacho, Kobe Hyogo-ku, Hyogo, 652-0042, Japan.

Satoshi Kawashima (S)

Kanda Naika Clinic, 5-21-3, Hannancho, Osaka Abeno-ku, Osaka, 545-0021, Japan.

Yasunori Sato (Y)

Department of Preventive Medicine and Public Health, Keio University School of Medicine, 45 Shinanomachi Shinjuku-ku, Tokyo, 160-8582, Japan.

Hirotaka Watada (H)

Department of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.

Iichiro Shimomura (I)

Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Tofogliflozin long-term effects on...
questionsmedicales.fr › Maladies cardiovasculaires › Tofogliflozin long-term effects on...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Techniques de diagnostic cardiovasculaire › Index de pression systolique cheville-bras › Tofogliflozin long-term effects on...
questionsmedicales.fr › Phénomènes physiologiques respiratoires et circulatoires › Phénomènes physiologiques cardiovasculaires › Épaisseur intima-média carotidienne › Tofogliflozin long-term effects on...
questionsmedicales.fr › Maladies endocriniennes › Diabète › Diabète de type 2 › Tofogliflozin long-term effects on...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Techniques de diagnostic cardiovasculaire › Analyse de l'onde de pouls › Tofogliflozin long-term effects on...
questionsmedicales.fr › Sciences humaines › Philosophie › Utopies › Tofogliflozin long-term effects on...
questionsmedicales.fr › Maladies cardiovasculaires › Maladies vasculaires › Artériopathies oblitérantes › Artériosclérose › Athérosclérose › Tofogliflozin long-term effects on...