Evidence mapPaperPMID 37742004Full record

Trial reportBMC gastroenterology2023

Effect of Empagliflozin and Pioglitazone on left ventricular function in patients with type two diabetes and nonalcoholic fatty liver disease without established cardiovascular disease: a randomized single-blind clinical trial.

Fereshte Attaran, Sepideh Emami, Masoudreza Sohrabi, Mojtaba Malek, Hossein Ajdarkosh, Mahmoodreza Khoonsari, Faramarz Ismail-Beigi, Mohammad E Khamseh

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 5% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Review
  9. 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

8 authors at 3 institutions in 2 countries.

Fereshte Attaran *Endocrine Research Center, Institute of Endocrinology and Metabolism, Department of Internal Medicine, School of Medicine, Iran University of Medical Science, No. 10, Firoozeh St., Vali-asr Ave., Vali-asr Sq, Tehran, Iran.
Sepideh Emami *Department of Cardiology, Firoozgar Hospital, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
Masoudreza SohrabiGastrointestinal and liver diseases research center, Iran University of Medical Sciences, Tehran, Iran.
Mojtaba MalekResearch Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran.
Hossein AjdarkoshGastrointestinal and liver diseases research center, Iran University of Medical Sciences, Tehran, Iran.
Mahmoodreza KhoonsariGastrointestinal and liver diseases research center, Iran University of Medical Sciences, Tehran, Iran.
Faramarz Ismail-BeigiSchool of Medicine, Case Western Reserve University, Cleveland, USA.
Mohammad E KhamsehEndocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Science, Tehran, Iran. khamseh.m@iums.ac.ir.
Iran University of Medical Sciences · IRCase Western Reserve University · USFiroozgar General Hospital · IR

Funding

Iran University of Medical Sciences IR.IUMS.REC.1398.1408
6 · The paper itself

Abstract

backgroundNonalcoholic fatty liver disease (NAFLD) is a complex metabolic disorder that increases the risk for cardiovascular disease in patients with type 2 diabetes mellitus (T2DM). Global longitudinal strain (GLS) is an indicator of left ventricular (LV) mechanics and can detect subclinical myocardial dysfunction. We compared the effects of pioglitazone and empagliflozin on GLS in patients with T2DM and NAFLD without established atherosclerotic cardiovascular disease.

methodsThis study was a 24-week randomized, single-blind, and parallel-group (1: 1 ratio) clinical trial. Seventy-three participants with T2DM (being treated with metformin) and NAFLD but without established atherosclerotic cardiovascular disease (ASCVD) were randomized to empagliflozin or pioglitazone. Liver steatosis and fibrosis were measured using transient elastography, and GLS was measured by echocardiography. The primary endpoint was the change in GLS from baseline to week 24. Secondary end points include changes in controlled attenuation parameter (CAP) and Liver stiffness measure (LSM).

resultsIn this study, GLS improved by 1.56 ± 2.34% (P < 0.01) in the pioglitazone group and 1.06 ± 1.83% (P < 0.01) in the empagliflozin group without a significant difference between the two groups (P = 0.31). At baseline, GLS was inversely associated with the severity of liver fibrosis: r = - 0.311, P = 0.007. LSM in the pioglitazone and empagliflozin group [(-0.73 ± 1.59) and (-1.11 ± 1.33)] kpa (P < 0.01) decreased significantly. It was without substantial difference between the two groups (P = 0.26). Empagliflozin and pioglitazone both improved controlled attenuation parameter. The improvement was more critical in the empagliflozin group: -48.22 + 35.02 dB/m vs. -25.67 + 41.50 dB/m, P = 0.01.

conclusionSubclinical cardiac dysfunction is highly important in patients with T2DM and with NAFLD. Empagliflozin and Pioglitazone improve LV mechanics and fibrosis in patients without established ASCVD. This has a prognostic importance on cardiovascular outcomes in high-risk patients with T2DM. Moreover, empagliflozin ameliorates liver steatosis more effectively them pioglitazone. This study can serve as a start point hypothesis for the future. Further studies are needed to explore the concept in larger populations.

trial registrationThis trial was registered in the Iranian Registry of Clinical Trials (IRCT): "A Comparison between the Effect of Empagliflozin and Pioglitazone on Echocardiographic Indices in Patients with Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease" IRCT20190122042450N5, 29 November 2020. https://www.irct.ir/search/result?query=IRCT20190122042450N5 .

Indexed as

Cardiovascular DiseasesDiabetes Mellitus, Type 2Non-alcoholic Fatty Liver DiseaseBenzhydryl CompoundsGlucosidesHumansIranPioglitazoneSingle-Blind MethodVentricular Function, LeftBenzhydryl CompoundsempagliflozinGlucosidesPioglitazoneClinical trialEmpagliflozinHeart, heart failureLiver cirrhosisNon-alcoholic fatty liver diseasePioglitazoneVentricular function

Identifiers

PMID37742004
PMCPMC10517489
OpenAlexW4386982899

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.