Evidence map›Paper›PMID 39823131›Full record

ArticleJournal of diabetes investigation2025

Post-hoc analysis of the tofogliflozin post-marketing surveillance study (J-STEP/LT): Tofogliflozin improves liver function in type 2 diabetes patients regardless of BMI.

Hiroyuki Uchinuma, Mitsunori Matsushita, Masaya Tanahashi, Hideki Suganami, Kazunori Utsunomiya, Kohei Kaku, Kyoichiro Tsuchiya

Abstract read
In one paragraph

Article in Journal of diabetes investigation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Review
  2. Article
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

7 authors.

Hiroyuki UchinumaDepartment of Diabetes and Endocrinology, University of Yamanashi Hospital, Yamanashi, Japan.
Mitsunori MatsushitaMedical Affairs Department I, Kowa Company, Ltd., Tokyo, Japan.
Masaya TanahashiData Science Center, Kowa Company, Ltd., Tokyo, Japan.
Hideki SuganamiData Science Center, Kowa Company, Ltd., Tokyo, Japan.
Kazunori UtsunomiyaNomura Hospital, Tokyo, Japan.
Kohei KakuDivision of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School, Okayama, Japan.ORCID https://orcid.org/0000-0003-1574-0565
Kyoichiro TsuchiyaDepartment of Diabetes and Endocrinology, University of Yamanashi Hospital, Yamanashi, Japan.ORCID https://orcid.org/0000-0002-2863-4561

Funding

Kowa Company, Ltd
6 · The paper itself

Abstract

AIMS/

introductionPatients with type 2 diabetes are at high risk of developing steatotic liver disease (SLD). Weight loss has proven effective in treating metabolic dysfunction-associated steatotic liver disease (MASLD) in obese patients with type 2 diabetes, with sodium-glucose cotransporter 2 (SGLT2) inhibitors showing promising results. However, lean MASLD is more prevalent in Japan, necessitating alternative approaches to body weight reduction. MATERIALS AND

methodsWe used the J-STEP/LT dataset including up to 3-year treatment data to analyze the effects of the SGLT2 inhibitor tofogliflozin on liver function and treatment safety and conducted a subgroup analysis based on body mass index (BMI; kg/m

resultsThis study included 4,208 participants. Tofogliflozin significantly reduced alanine aminotransferase (ALT) levels in participants with baseline ALT levels >30 U/L across all BMI groups, with median changes of -12, -16, -13, -15, and -15 U/L, respectively (P = 0.9291 for trends). However, median changes in body weight with tofogliflozin were -2.00, -2.75, -2.00, -3.00, and -3.80 kg, respectively (P < 0.0001 for trends), with no significant weight loss observed in the BMI <20 group. ALT levels were also significantly decreased in participants who did not lose weight. Safety assessments according to BMI and age categories revealed no clear differences in the frequency of adverse events.

conclusionsTofogliflozin reduced ALT levels without substantial body weight reduction among lean participants. These findings suggest that SGLT2 inhibitors may be a viable treatment option for non-obese patients with type 2 diabetes and SLD.

Indexed as

Benzhydryl CompoundsDiabetes Mellitus, Type 2GlucosidesLiverProduct Surveillance, PostmarketingSodium-Glucose Transporter 2 InhibitorsAdultAgedBiomarkersBody Mass IndexFemaleFollow-Up StudiesHumansJapanLiver Function TestsMale6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triolBenzhydryl CompoundsBiomarkersGlucosidesSodium-Glucose Transporter 2 InhibitorsBMIMASLDSGLT2 inhibitors

Identifiers

PMID39823131
PMCPMC11970296

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.