Evidence map›Paper›PMID 37349722›Full record

Trial reportCardiovascular diabetology2023

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.

Naoto Katakami, Tomoya Mita, Hidenori Yoshii, Toshihiko Shiraiwa, Tetsuyuki Yasuda, Yosuke Okada, Akira Kurozumi, Masahiro Hatazaki, Hideaki Kaneto, Takeshi Osonoi and 17 more

Open access · goldAbstract readRandomized Controlled TrialObservational Study
In one paragraph

Trial report in Cardiovascular diabetology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.6field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
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  3. Review
  4. Article
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  6. Observational
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 18 institutions in 1 country.

Naoto KatakamiDepartment of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. katakami@endmet.med.osaka-u.ac.jp.
Tomoya MitaDepartment of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.
Hidenori YoshiiDepartment of Medicine, Diabetology & Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Koto-ku, Tokyo, 136-0075, Japan.
Toshihiko ShiraiwaShiraiwa Medical Clinic, 4-10-24 Hozenji, Kashiwara, Osaka, 582-0005, Japan.
Tetsuyuki YasudaDepartment of Endocrinology and Metabolism, Osaka Police Hospital, 10-31, Kitayama-Cho, Tennoji-ku, Osaka, 543-0035, Japan.
Yosuke OkadaFirst Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
Akira KurozumiFirst Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
Masahiro HatazakiDepartment of Diabetes and Endocrinology, Osaka General Medical Center, 3-1-56, Bandai-Higashi, Sumiyoshi-ku, Osaka, 558-8558, Japan.
Hideaki KanetoDepartment of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.
Takeshi OsonoiNakakinen Clinic, 745-5, Nakadai, Naka, Ibaraki, 311-0113, Japan.
Tsunehiko YamamotoDiabetes and Endocrinology, Kansai Rosai Hospital, 3-1-69, Inabaso, Amagasaki, Hyogo, Japan.
Nobuichi KuribayashiMisaki Naika Clinic, 6-44-9, Futawa-Higashi, Funabashi, Chiba, Japan.
Kazuhisa MaedaKitasenri Maeda Clinic, 4-119, Furuedai, Suita, Osaka, 565-0874, Japan.
Hiroki YokoyamaJiyugaoka Medical Clinic, West 6, South 6-4-3, Obihiro, Hokkaido, 080-0016, Japan.
Keisuke KosugiKosugi Medical Clinic, 3-9, Tamatsukurimoto-Cho, Tennoji-ku, Osaka, 543-0014, Japan.
Kentaro OhtoshiOtoshi Medical Clinic, 8-47, KakudachoOsaka Kita-ku, Osaka, 530-0017, Japan.
Isao HayashiHayashi Clinic, 3-9-23, Koshienguchi, Nishinomiya, Hyogo, 663-8113, Japan.
Satoru SumitaniCenter for Diabetes and Endocrinology, Nippon Life Hospital, 2-1-54 Enokojima, Nishi-ku, Osaka, 550-0006, Japan.
Mamiko TsugawaDepartment of Endocrinology and Metabolism, Ikeda Municipal Hospital, 3-1-18, Jonan, Ikeda, Osaka, 563-8510, Japan.
Kayoko RyomotoCenter for Diabetes Mellitus, Osaka Rosai Hospital, 1179-3 Nagasone-Cho, Kita-ku, Sakai, Osaka, 591-8025, Japan.
Ken KatoDiabetes Center, National Hospital Organization Osaka National Hospital, 2-1-14, Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan.
Tadashi NakamuraDepartment of Internal Medicine, Kawasaki Hospital, 3-3-1, Higashiyamacho, Kobe Hyogo-ku, Hyogo, 652-0042, Japan.
Satoshi KawashimaKanda Naika Clinic, 5-21-3, Hannancho, Osaka Abeno-ku, Osaka, 545-0021, Japan.
Yasunori SatoDepartment of Preventive Medicine and Public Health, Keio University School of Medicine, 45 Shinanomachi Shinjuku-ku, Tokyo, 160-8582, Japan.
Hirotaka WatadaDepartment of Metabolism & Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.
Iichiro ShimomuraDepartment of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
UTOPIA study investigators
Keio University · JPThe University of Osaka · JPJuntendo University · JPKawasaki Hospital · JPOsaka Rosai Hospital · JPUniversity of Occupational and Environmental Health Japan · JPFutaba (Japan) · JPHayashi Eye Hospital · JPHoshigaoka Medical Center · JPKansai Rosai Hospital · JPKawasaki Medical School · JPKoto Hospital · JPMiwa Hospital · JPOsaka National Hospital · JPOsaka Police Hospital · JPOsaka Prefectural Medical Center · JPSaiseikai Ibaraki Hospital · JPTochigi Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis 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.

methodsThis 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.

resultsThe 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.

conclusionsTofogliflozin 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.

Indexed as

AtherosclerosisCardiovascular DiseasesDiabetes Mellitus, Type 2Ankle Brachial IndexBenzhydryl CompoundsCarotid Intima-Media ThicknessGlucosidesHumansPulse Wave AnalysisUtopias6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triolBenzhydryl CompoundsGlucosidesAtherosclerosisBrachial-ankle pulse wave velocityCardiovascular risk factorsCarotid intima-media thicknessSodium-glucose cotransporter 2 inhibitorTofogliflozin

Identifiers

PMID37349722
PMCPMC10286339
OpenAlexW4381615652

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.