Evidence map›Paper›PMID 32975679›Full record

Trial reportAdvances in therapy2020

Effect of Empagliflozin on Liver Steatosis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease Without Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial.

Hoda Taheri, Mojtaba Malek, Faramarz Ismail-Beigi, Farhad Zamani, Masoudreza Sohrabi, Mohammad Reza Babaei, Mohammad E Khamseh

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 108 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 16 pooled it
12.9field-weighted citation impact, top 1% 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

108 citing papers in PubMed, 16 syntheses or guidelines pooled it, 182 citations in OpenAlex.

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48 more citing papers are in PubMed but not listed here.

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 at 2 institutions in 2 countries.

Hoda TaheriEndocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.
Mojtaba MalekResearch Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran. malek.m@iums.ac.ir.
Faramarz Ismail-BeigiDepartment of Medicine, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA.
Farhad ZamaniGastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.
Masoudreza SohrabiGastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.
Mohammad Reza BabaeiDepartment of Interventional Radiology, Firouzgar Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran.
Mohammad E KhamsehEndocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.
Iran University of Medical Sciences · IRCase Western Reserve University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDespite the high prevalence of non-alcoholic fatty liver disease (NAFLD) and its associated co-morbidities, no efficient treatment in a high percentage of individuals is available. Beneficial effects of sodium-glucose co-transporter 2 inhibitors on fatty liver have been investigated in people with type 2 diabetes (T2DM). The aim of this study was to explore the effect of empagliflozin on liver steatosis and fibrosis in patients with NAFLD without T2DM.

methodsIn this prospective randomized, double-blind, placebo-controlled clinical trial, participants with NAFLD were randomized to empagliflozin (10 mg/day) (n = 43) or placebo (n = 47) for 24 weeks. Hepatic steatosis and fibrosis were assessed using transient elastography to measure the controlled attenuation parameter (CAP) and liver stiffness measurement (LSM). The primary outcome was the change in CAP score at 24 weeks.

resultsThere was significant decrease in CAP score in both groups but no significant difference was observed between the two groups (P = 0.396). LSM was significantly decreased in the empagliflozin-treated group (6.03 ± 1.40 to 5.33 ± 1.08 kPa; P = 0.001), while no change was found in the placebo group. In subgroups analysis of patients with significant steatosis at baseline (CAP ≥ 302 dB/m), steatosis significantly improved in the empagliflozin group (37.2% vs. 17%; P = 0.035). There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.

conclusionsEmpagliflozin improves liver steatosis and, more importantly, measures of liver fibrosis in patients with NAFLD without T2DM.

trial registrationClinicalTrials.gov identifier, IRCT20190122042450N1.

Indexed as

Diabetes Mellitus, Type 2Non-alcoholic Fatty Liver DiseaseBenzhydryl CompoundsGlucosidesHumansLiverProspective StudiesBenzhydryl CompoundsempagliflozinGlucosidesEmpagliflozinLiver fibrosisNon-alcoholic fatty liver diseaseSteatosisTransient elastography

Identifiers

PMID32975679
PMCPMC7547956
OpenAlexW3088344065

What OpenQuestion holds

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LicenceCC BY-NC
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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.