Two‐tier screening approach for liver fibrosis stratification in outpatients with type 2 diabetes mellitus: A multicenter cross‐sectional study

Abstract Background To examine the prevalence and severity of metabolic dysfunction‐associated steatotic liver disease (MASLD) in outpatients with type 2 diabetes mellitus (T2DM), and to assess the effectiveness of the EASL‐EASD‐EASO algorithm for liver fibrosis screening. Methods We retrospectively enrolled 1203 Italian older outpatients with T2DM who underwent vibration‐controlled transient elastography (VCTE) with liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) assessment. MASLD was defined as CAP ≥248 dB/m. Significant liver fibrosis was defined as LSM ≥8 kPa, compensated advanced chronic liver disease (cACLD) as LSM ≥10 kPa, and clinically significant portal hypertension (CSPH) as LSM ≥25 kPa or LSM ≥20 kPa and platelet count <150 000/mm 3 . FIB‐4 index was calculated in all participants. Results The prevalence rates of MASLD, significant liver fibrosis, cACLD, and CSPH were 71.3%, 21.1%, 11.7% and 1.7%, respectively. A 2‐tier screening strategy for liver fibrosis using the FIB‐4 index and VCTE showed that among patients with a normal FIB‐4 index, 629 (83.3%) had LSM <8 kPa and 126 (16.7%) had LSM≥8 kPa. Sensitivity, specificity, NPV, and PPV of the FIB‐4 index for detecting LSM≥8 kPa were 50.4%, 66.3%, 83.3% and 28.6%, respectively. Increased body weight (adjusted‐OR 3.34, 95%CI 1.75–6.39) and elevated ALT levels (adjusted‐OR 1.54, 95%CI 1.01–2.36) were the strongest predictors of significant liver fibrosis. Conclusions MASLD and significant liver fibrosis are common in older patients with T2DM. Fibrosis risk stratification using FIB‐4, followed by VCTE, is a good strategy in real‐world settings. However, relying solely on FIB‐4 may fail to identify some patients with advanced disease, particularly those with increased body weight and elevated serum aminotransferase levels.