Nutrition, metabolism, and cardiovascular diseases : NMCD · 2025
Impact of empagliflozin as add-on to metformin vs metformin continuation on MASLD progression in type 2 diabetes: The IMAGIN Study.
СтатьяНаблюдательное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Caturano Alfredo, Galiero Raffaele, Simeon Vittorio, Acierno Carlo, Nilo Davide, Marrone Aldo, Trotta Maria Consiglia, Vetrano Erica, Sardu Celestino, Russo Vincenzo, Conte Caterina, D'Onofrio Nunzia, Chiodini Paolo, Marfella Raffaele, Balestrieri Maria Luisa, D'Amico Michele, Rinaldi Luca, Sasso Ferdinando Carlo
Аннотация
BACKGROUND AND AIM: MASLD is the leading cause of chronic liver disease. This study evaluated the effects of empagliflozin + metformin (combination therapy) versus metformin monotherapy (control) on MASLD progression in type 2 diabetes (T2D) patients.
METHODS AND RESULTS: This single-center, prospective observational study included SGLT2i-naïve adults with metformin-treated T2D, eGFR ≥45 mL/min/1.73 m2, and MASLD. FibroScan®/CAP, biochemical, and anthropometric assessments were conducted at baseline, 6 months, and 12 months. Eighty-eight patients were enrolled (47 controls, 41 combination therapy). At 12 months, combination therapy led to significantly greater improvements in BMI, ALT, HbA1c, CAP, and liver stiffness (p < 0.05). It was associated with higher odds of steatosis (OR 9.79, p < 0.001) and fibrosis improvement (OR 5.31, p = 0.001). Changes in BMI and HbA1c did not correlate with CAP or liver stiffness improvement. Exploratory miRNA analysis (n = 17) suggested potential moderate negative correlations between baseline miR-122 and steatosis improvement (r = -0.4820, p = 0.050) and miR-21 and fibrosis improvement (r = -0.5410, p = 0.014).
CONCLUSIONS: Empagliflozin + metformin improved liver parameters more effectively than metformin alone in T2D patients with MASLD. Baseline miR-122 and miR-21 may serve as potential biomarkers for steatosis and fibrosis improvement, respectively.
METHODS AND RESULTS: This single-center, prospective observational study included SGLT2i-naïve adults with metformin-treated T2D, eGFR ≥45 mL/min/1.73 m2, and MASLD. FibroScan®/CAP, biochemical, and anthropometric assessments were conducted at baseline, 6 months, and 12 months. Eighty-eight patients were enrolled (47 controls, 41 combination therapy). At 12 months, combination therapy led to significantly greater improvements in BMI, ALT, HbA1c, CAP, and liver stiffness (p < 0.05). It was associated with higher odds of steatosis (OR 9.79, p < 0.001) and fibrosis improvement (OR 5.31, p = 0.001). Changes in BMI and HbA1c did not correlate with CAP or liver stiffness improvement. Exploratory miRNA analysis (n = 17) suggested potential moderate negative correlations between baseline miR-122 and steatosis improvement (r = -0.4820, p = 0.050) and miR-21 and fibrosis improvement (r = -0.5410, p = 0.014).
CONCLUSIONS: Empagliflozin + metformin improved liver parameters more effectively than metformin alone in T2D patients with MASLD. Baseline miR-122 and miR-21 may serve as potential biomarkers for steatosis and fibrosis improvement, respectively.
Предметные рубрики MeSH
HumansMetforminBenzhydryl CompoundsGlucosidesDiabetes Mellitus, Type 2MaleFemaleMiddle AgedProspective StudiesSodium-Glucose Transporter 2 InhibitorsDisease ProgressionTreatment OutcomeHypoglycemic AgentsDrug Therapy, CombinationAgedBiomarkersTime FactorsMicroRNAsGlycated HemoglobinBlood GlucoseLiver CirrhosisNon-alcoholic Fatty Liver DiseaseAdult