Patients with NAFLD and T2DM are at high risk of liver fibrosis. Pioglitazone(Pio) and GLP-1RAs have shown efficacy against NAFLD. The EDICT trial assessed Triple (pio/exenatide/metformin(met)) vs. Conventional(Conv) (met/SU/insulin) Therapy.
Aim: Evaluate the effect of these approaches on liver fibrosis scores and hepatic fibrosis, steatosis (FibroScan).
Methods: 144 newly diagnosed T2DM were randomized to receive Triple or Conv Therapy to maintain HbA1c <6.5%. After 2 yrs baseline measurements were repeated and liver fibrosis scores (AST/ALT ratio, APRI, FIB-4, NFS) were calculated.
Results: Patients were well matched for age, BMI, HbA1c (8.8%), LFTs. Neither therapy reduced any liver fibrosis score. Triple, but not Conv, reduced AST/ALT (p<0.001). The greatest AST/ALT reductions with Triple Therapy occurred in subjects in highest AST/ALT tertile at baseline. Only 1 subject receiving Triple Therapy had fibrosis score >0, while 43% of Conv Therapy subjects had fibrosis score of F3/F4 (p<0.0001). 87% of Conv Therapy subjects had steatosis score of S2/S3 vs. to 38% of Triple Therapy (p<0.001) (Table).
Conclusion: Both Triple (6.0%) and Conventional Therapy (6.7%) markedly reduced HbA1c after 2 yrs, but only Triple Therapy reduced AST/ALT. Fibrosis scores did not change in either group and are not useful in predicting response to therapy. Triple Therapy completely prevented fibrosis and reduced steatosis by >50 % vs. Conventional Therapy.
O. Lavrynenko: None. M. Alatrach: None. M. Abdul-Ghani: None. E. Cersosimo: None. N. Alkhouri: Research Support; Self; Allergan plc. C.L. Puckett: None. R.A. DeFronzo: None. J.M. Adams: None. J.A. Vasquez: None. G.D. Clarke: None.