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Efficacy of dapagliflozin on hepatic steatosis and fibrosis in patients with type 2 diabetes mellitus and metabolic dysfunction-associated steatotic liver disease: a pre-specified single-arm analysis from a randomized controlled trial.

Das Sambit·Das Bijay Ketan·Sahoo Devadarshini·Choudhury Arun Kumar·Meher Dayanidhi·Nath Preetam·Padhee Sourav·Prusty Binod·Agarwal Vishal·Sahu Sandeep Kumar
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Abstract

AIM: To evaluate the association of dapagliflozin therapy with changes in hepatic steatosis and non-invasive fibrosis surrogate markers in patients with type 2 diabetes mellitus (T2DM) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) over 12&#xa0;months. METHODS: This is a pre-specified single-arm analysis from a randomised, open-label, parallel-group trial. Of 54 participants randomised to dapagliflozin 10&#xa0;mg daily, 50 (92.6%) completed the 12-month follow-up and were included in the per-protocol analysis. Assessments at baseline, 3, 6, and 12&#xa0;months included transient elastography (CAP and LSM), ultrasonography, and biochemical tests. Primary endpoints were changes in hepatic steatosis (CAP) and non-invasive fibrosis surrogates (LSM). RESULTS: Significant reductions were observed in hepatic steatosis (CAP: 316.7 to 245.7&#xa0;dB/m; mean change&#xa0;-&#xa0;71.02&#xa0;dB/m, 95% CI: -63.4 to&#xa0;-&#xa0;78.6; p&#xa0;<&#xa0;0.001) and in liver stiffness as a non-invasive fibrosis surrogate (LSM: 8.59 to 7.28&#xa0;kPa; mean change&#xa0;-&#xa0;1.31&#xa0;kPa, 95% CI: -0.92 to&#xa0;-&#xa0;1.70; p&#xa0;<&#xa0;0.001). Improvements were also observed in glycaemic control, body weight, lipid profile, liver enzymes, ultrasonographic steatosis grading, and serum fibrosis markers. Genitourinary infections were the most frequently reported adverse events (32%); no serious adverse events were recorded. CONCLUSIONS: Dapagliflozin was associated with significant improvements in hepatic steatosis, non-invasive fibrosis surrogate markers, metabolic parameters, and liver function in T2DM patients with MASLD over 12&#xa0;months. These findings provide region-specific evidence for an Indian population and support further controlled investigation. However, these findings should be interpreted in light of the pre-specified single-arm design of this analysis, the open-label methodology, relatively small sample size, and the absence of liver biopsy confirmation.

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HumansBenzhydryl CompoundsGlucosidesDiabetes Mellitus, Type 2FemaleMaleMiddle AgedLiver CirrhosisFatty LiverSodium-Glucose Transporter 2 InhibitorsAdultTreatment OutcomeAgedElasticity Imaging TechniquesLiverDapagliflozinHepatic steatosisLiver fibrosisMetabolic dysfunction-associated steatotic liver diseaseSGLT2 inhibitorTransient elastographyType 2 diabetes mellitusJournal ArticleRandomized Controlled Trial

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Das Sambit, Das Bijay Ketan, Sahoo Devadarshini, Choudhury Arun Kumar, Meher Dayanidhi, Nath Preetam, Padhee Sourav, Prusty Binod, Agarwal Vishal, Sahu Sandeep Kumar. 2026-08-25. Efficacy of dapagliflozin on hepatic steatosis and fibrosis in patients with type 2 diabetes mellitus and metabolic dysfunction-associated steatotic liver disease: a pre-specified single-arm analysis from a randomized controlled trial.. https://doi.org/10.1016/j.diabres.2026.113512

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