Liver and Bile
Gastroenterology. 2023;165(2):463–72.e5
Fibrosis progression rate in biopsy-proven non-alcoholic fatty liver disease among people with diabetes versus people without diabetes: A multicenter study
Background and aims: There are limited data regarding fibrosis progression in biopsy-proven non-alcoholic fatty liver disease (NAFLD) in people with type 2 diabetes mellitus (T2DM) compared with people without T2DM. The time to fibrosis progression was assessed in people with T2DM compared with people without T2DM in a large, multicenter study of people with NAFLD who had paired liver biopsies.
Methods: This study included 447 adult participants (64% were female) with NAFLD who had paired liver biopsies more than 1 year apart. Liver histology was systematically assessed by a central pathology committee blinded to clinical data. The primary outcome was the cumulative incidence of a ≥ 1-stage increase in fibrosis in participants with T2DM compared with participants without T2DM.
Results: The mean (SD) age and body mass index (calculated as weight in kilograms divided by the square of the height in meters) were 50.9 (11.5) years and 34.7 (6.3), respectively. The median time between biopsies was 3.3 years (interquartile range, 1.8–6.1 years). Participants with T2DM had a significantly higher cumulative incidence of fibrosis progression at 4 years (24% vs. 20%), 8 years (60% vs. 50%), and 12 years (93% vs. 76%) (p = 0.005). Using a multivariable Cox proportional hazards model adjusted for multiple confounders, T2DM remained an independent predictor of fibrosis progression (adjusted hazard ratio = 1.69; 95% confidence interval: 1.17–2.43; p = 0.005). The cumulative incidence of fibrosis regression by ≥ 1 stage was similar in participants with T2DM compared with participants without T2DM (p = 0.24).
Conclusions: In this large, multicenter cohort study of well-characterized participants with non-alcoholic fatty liver disease and paired liver biopsies, the authors found that fibrosis progressed faster in participants with type 2 diabetes mellitus (T2DM) compared with participants without T2DM. These data have important implications for clinical practice and trial design.