Evidence map›Paper›PMID 28669071›Full record

ArticleJournal of gastroenterology2018

Effects of canagliflozin, an SGLT2 inhibitor, on hepatic function in Japanese patients with type 2 diabetes mellitus: pooled and subgroup analyses of clinical trials.

Yuya Seko, Yoshio Sumida, Kazuyo Sasaki, Yoshito Itoh, Hiroaki Iijima, Toshio Hashimoto, Shinichi Ishii, Nobuya Inagaki

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In one paragraph

Article in Journal of gastroenterology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
–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

28 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

8 authors.

Yuya SekoDepartment of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan. yuyaseko@koto.kpu-m.ac.jp.
Yoshio SumidaDepartment of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Kazuyo SasakiMitsubishi Tanabe Pharma Corporation, Osaka, Japan.
Yoshito ItohDepartment of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Hiroaki IijimaMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Toshio HashimotoMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Shinichi IshiiMitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Nobuya InagakiDepartment of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe aimed to investigate the efficacy of canagliflozin (based on its effect on liver function and blood glucose levels) and its safety in high alanine aminotransferase (ALT) patients (ALT >30 U/L).

methodsThis post hoc analysis of canagliflozin in type 2 diabetes mellitus (T2DM) patients was divided into Study 1 (pooled analysis of 12- and 24-week placebo-controlled, monotherapy studies) and Study 2 (52-week monotherapy/combination therapy study). The canagliflozin 100 mg group data were compared with placebo or baseline ALT subgroup (baseline ALT >30 or ≤30 U/L) data. The primary endpoint was change in ALT level from baseline. Secondary endpoints were changes in efficacy-related parameters. Adverse events (AEs) were evaluated.

resultsThe mean ALT change at 12 weeks was -10.3 ± 11.7 and -3.2 ± 17.6 U/L in the canagliflozin vs. placebo group in the high ALT subgroup (P = 0.0206); no significant difference was shown in the low ALT subgroup (Study 1). In both ALT subgroups, glycosylated hemoglobin (HbA1c) and body weight were significantly reduced in the canagliflozin vs. placebo group (all P < 0.0001). The mean change in ALT at 52 weeks was -16.0 ± 18.8 U/L in the high ALT subgroup (P < 0.0001, Study 2). The incidence of AEs or serious AEs in the high ALT subgroup in the canagliflozin group was similar to that in the placebo group (Study 1) or low ALT subgroup (Studies 1 and 2).

conclusionsIn T2DM patients with impaired liver function, canagliflozin may improve liver function, reduce HbA1c and body weight, and be well tolerated.

Indexed as

AdultAgedBlood GlucoseBody WeightCanagliflozinDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansHypoglycemic AgentsLiver DiseasesLiver Function TestsMaleMiddle AgedRandomized Controlled Trials as TopicSodium-Glucose Transporter 2 InhibitorsBlood GlucoseCanagliflozinGlycated HemoglobinHypoglycemic AgentsSodium-Glucose Transporter 2 InhibitorsAlanine aminotransferaseCanagliflozinHepatic functionJapanType 2 diabetes mellitus

Identifiers

PMID28669071

What OpenQuestion holds

Texttitle and abstract
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Registered trials

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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.