Data about liver fibrosis in T2DM are scarce. The FIB-4 index is a non-invasive panel to evaluate underlying hepatic fibrosis. FIB-4 values <1.45 and ≥3.25 were reported to have a negative predictive value (NPV) of ∼90% and PPV of∼65% for advanced fibrosis. FIB-4 values ≥ 2.67 were reported to be associated with 16X increase in clinical outcomes in NAFLD. FIB-4 range ≥1.45 < 2.67 is suggested to be an indeterminate area. We assessed FIB-4 values and their changes over 4 years in 334,076 patients (48% males) with T2DM. A total of 75.2%, 22.3%, 1.3% and 1.2% of subjects had FIB-4≥ 1.45 (G1), ≥1.45 <2.67 (G2), ≥ 2.67<3.25 (G3) and ≥3.25 (G4). Subjects with low FIB-4 were younger, had lower ALT/AST and higher platelet counts (Table). Almost 50% of the patients with FIB-4≥ 2.67 had ALT/AST within reference ranges (RR). Mean plasma TG and HbA1C were similar among groups. Among G1 patients, 83% stayed G1, 16.3% progressed to G2 and 0.7% had FIB-4 ≥ 2.67 after 4 years. A total of 10% and 27% of patients initially in G2 and G3 progressed to FIB-4 associated with higher risk of liver outcomes.
Conclusion: Only 75% of the patients had FIB-4 suggesting absence of advanced liver fibrosis, ∼ 50% of subjects at risk of liver outcomes had ALT/AST within RR. FIB-4 is a simple, inexpensive method that may help identify patients at risk of liver outcomes. Strategies to slow the growth of liver complications and therapeutic options are necessary to mitigate disease burden.
C.M. Filozof: Employee; Self; Covance Inc.. S. Jones: None. B.J. Goldstein: Employee; Self; Covance Inc..