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. 2023 Jan 23;11(2):322.
doi: 10.3390/biomedicines11020322.

Effects of a Combination of Empagliflozin Plus Metformin vs. Metformin Monotherapy on NAFLD Progression in Type 2 Diabetes: The IMAGIN Pilot Study

Alfredo Caturano  1   2 , Raffaele Galiero  1 , Giuseppe Loffredo  1 , Erica Vetrano  1 , Giulia Medicamento  1 , Carlo Acierno  1 , Luca Rinaldi  1 , Aldo Marrone  1 , Teresa Salvatore  2 , Marcellino Monda  2 , Celestino Sardu  1 , Raffaele Marfella  1 , Ferdinando Carlo Sasso  1
Affiliations

Effects of a Combination of Empagliflozin Plus Metformin vs. Metformin Monotherapy on NAFLD Progression in Type 2 Diabetes: The IMAGIN Pilot Study

Alfredo Caturano et al. Biomedicines. .

Abstract

Non-alcoholic fatty liver disease (NAFLD) comprises a heterogeneous group of metabolic liver diseases and is characterized by the presence of steatosis in at least 5% of hepatocytes. The aim of our study was to assess the effect of the combination therapy of empagliflozin + metformin vs. metformin monotherapy on NAFLD progression in type 2 diabetic (T2DM) patients. Sixty-three metformin-treated T2DM patients who were SGLT2i-naïve and had an ultrasound diagnosis of NAFLD (aged 60.95 ± 11.14 years; males, 57.1%) were included in the present analysis. Thirty-three started the combination therapy. All patients were observed for 6 months and routinely monitored with anthropometry, blood biochemistry, and FibroScan®/CAP. At the 6-month follow-up, the combination therapy group presented a significant reduction in BMI (30.83 ± 3.5 vs. 28.48 ± 3.25), glycated hemoglobin (8.2 (7.4-8.8)) vs. 7.2 (6.8-7.9), ALT (68.5 (41.5-88.0) vs. 45.00 (38.00, 48.00)), CAP parameter (293.5 (270.0-319.25) vs. 267.00 (259.50, 283.75)) and steatosis degree (p = 0.001) in comparison with the control group, whose parameters remained almost stable over time. In patients affected by T2DM, the combination of empagliflozin + metformin vs. metformin monotherapy ameliorated liver steatosis, ALT levels, body weight, and glycated hemoglobin after a 6-month follow-up.

Keywords: FibroScan®; controlled attenuation parameter; metformin; non-alcoholic fatty liver disease; sodium-glucose cotransporter inhibitors; type 2 diabetes.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Box plot analysis of CAP variation in case and control groups.
See this image and copyright information in PMC

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