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

BMC Gastroenterology

Research

Sepideh Emami¹  Fereshte Attaran²  Mohammad E. Khamseh³  Masoudreza Sohrabi⁴  Hossein Ajdarkosh⁴  Mahmoodreza Khoonsari⁴  Mojtaba Malek⁵  Faramarz Ismail-Beigi⁶ 

[1] Department of Cardiology, Firoozgar Hospital, School of Medicine, Iran University of Medical Sciences, Tehran, Iran;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;Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Science, Tehran, Iran;Gastrointestinal and liver diseases research center, Iran University of Medical Sciences, Tehran, Iran;Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran;School of Medicine, Case Western Reserve University, Cleveland, USA;

关键词: Empagliflozin;    Pioglitazone;    Ventricular function;    Liver cirrhosis;    Non-alcoholic fatty liver disease;    Heart, heart failure;    Clinical trial;   

DOI  :  10.1186/s12876-023-02948-4

 received in 2022-07-30, accepted in 2023-09-06,  发布年份 2023

来源: Springer

【 摘 要 】

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 registration: This 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.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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