Effectiveness of a model of care based on Fibrosis-4 and liver stiffness measurement for the screening of patients with type 2 diabetes mellitus at risk of advanced liver disease: results from an Italian prospective multicentre study.

BACKGROUND AIMS Patients with type 2 diabetes mellitus (T2DM) are at increased risk for metabolic dysfunction-associated steatotic liver disease (MASLD), advanced liver fibrosis, and metabolic dysfunction-associated steatohepatitis (MASH). We evaluated the prevalence and severity of MASLD among patients with T2DM at their first referral to diabetes clinics, and assessed the effectiveness of the 2-tier screening approach by Fibrosis-4 (FIB-4) and vibration-controlled transient elastography (VCTE). METHODS Consecutive patients with T2DM from six different diabetes clinics were prospectively enrolled. Liver stiffness measurement (LSM) was assessed by VCTE, while liver steatosis by controlled attenuation parameter (CAP) (Fibroscan, Echosens, France). "At risk MASH" was assessed by FibroScan-AST (FAST) score. RESULTS 800 patients (median age: 59, 53-65 years; males: 485, 60.6%) met the inclusion criteria. Prevalence of liver steatosis (CAP ≥ 248 db/m) was 73.6%. The proportion of patients at medium/high risk of advanced liver fibrosis (LSM ≥ 8.0 kPa) was 16.9%. Patients with "at risk MASH" (FAST > 0.67) were 12.0%.A 2-tier screening for advanced liver fibrosis by FIB-4 and VCTE would have led to 70 (8.8%) patients referred to liver clinics with a false-negative rate of 9.6% (n = 77; patients with FIB-4 < 1.3 and LSM ≥ 8.0 kPa). At multivariate analysis, overweight/obesity (OR = 3.13, 95%CI 1.23-7.97) and elevated ALT (OR = 1.91, 95%CI 1.17-3.10) were independently associated with LSM ≥ 8.0 kPa in patients with FIB-4 < 1.3. CONCLUSIONS In diabetes clinics, the 2-tier screening using FIB-4 and VCTE is effective for the identification of T2DM patients to be referred to hepatologists. VCTE referral may be considered for patients with overweight/obesity and elevated ALT classified as at low risk of advanced liver fibrosis by FIB-4.