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Public Release Type:
Journal
Publication Year: 2024
Affiliation: 1Eli Lilly and Company, Value Evidence Outcomes (VEO) – Diabetes, 893 S. Delaware Street, Indianapolis, IN, 46225, USA
2University of Toledo, College of Pharmacy and Pharmaceutical Sciences, 3000 Arlington Ave, Toledo, OH, 43614, USA
3University of Cincinnati, 3255 Eden Ave, Department of Pharmacy Practice and Administrative Sciences, Winkle College of Pharmacy, Cincinnati, OH, 45267, USA
Request IDs:
23059
Studies:
Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Children
,
Nonalcoholic Fatty Liver Disease (NAFLD) Adult Database
,
Nonalcoholic Fatty Liver Disease (NAFLD) Pediatric Database
,
The Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment
,
The Nonalcoholic Steatohepatitis Research Network (NASH CRN) Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis
,
Treatment of Nonalcoholic Fatty Liver Disease in Children
Background & Aims: We examined the roles of type 2 diabetes (T2D) and obesity in disease activity and fibrosis progression/regression in patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH). Methods: This multi-center, retrospective study included patients with suspected or histologically proven NAFLD/NASH from the NASH Clinical Research Network. Outcomes were disease activity and rate of fibrosis assessed using liver-biopsy driven measures (NAFLD activity score [NAS] and fibrosis score [FS]). Logistic regression and doubly robust estimation of causal effects tested relationships among T2D, obesity, and NAFLD/NASH. Results: The analytical sample included 870 adult patients with baseline biopsy data and 157 patients with multiple biopsy data. Patients with NAFLD/NASH and T2D had significantly higher baseline average NAS (4.52 vs. 4.13; P=0.009) and FS (2.17 vs. 1.56; P<0.0001); those with T2D had a significantly greater reduction in average NAS over time (-0.77 vs. -0.17; P=0.0008). Change in FS over time did not differ significantly by T2D status (-0.23 vs. -0.04; P=0.34). Baseline NAS, baseline FS, and change in average NAS over time did not differ significantly by obesity status (4.17 vs. 4.47; P=0.16; 1.73 vs.1.92; P=0.31; -0.40 vs. -0.59; P=0.62, respectively). Patients with obesity had a slight increase in FS but those without obesity had a reduction in average FS over time (0.07/year vs. -0.27/year; P=0.008). Conclusions: Patients with NAFLD/NASH and T2D had greater baseline disease activity versus those without T2D but there was greater regression of disease activity over time among those with T2D. Patients with NAFLD/NASH and obesity had worsening of fibrosis versus those without obesity.
