In a 72-week, randomized controlled trial of obeticholic acid in non-alcoholic steatohepatitis, obeticholic acid was superior to placebo in improving serum alanine aminotransferase levels and liver histology.
Dr Hameed and colleagues of California, USA investigated whether obeticholic acid therapy also reduced weight.
Because weight loss by itself can improve histology, to perform a post hoc analysis of the effects of weight loss and obeticholic acid treatment in improving clinical and metabolic features of non-alcoholic steatohepatitis.
The analysis was limited to the 200 patients with baseline and end-of-treatment liver biopsies.
Weight loss was defined as a relative decline from baseline of 2% or more at treatment end.
The team noted that weight loss occurred in 44% of obeticholic acid and 32% of placebo-treated patients.
The non-alcoholic fatty liver disease activity score improved more in those with than without weight loss in both the obeticholic acid- and placebo-treated patients.
|Weight loss occurred in 44% of obeticholic acid
|Alimentary Pharmacology and Therapeutics
Alanine aminotransferase levels also improved in those with vs without weight loss in obeticholic acid- and placebo-treated patients.
However, among those who lost weight, obeticholic acid was associated with opposite effects from placebo on changes in alkaline phosphatase, total and LDL cholesterol, and HbA1c .
Dr Hameed's team concludes, "Obeticholic acid leads to weight loss in up to 44% of patients with non-alcoholic steatohepatitis, and obeticholic acid therapy and weight loss have additive benefits on serum aminotransferases and histology."
"However, favorable effects of weight loss on alkaline phosphatase, lipids and blood glucose seen in placebo-treated patients were absent or reversed on obeticholic acid treatment."
"These findings stress the importance of assessing concomitant metabolic effects of new therapies of non-alcoholic steatohepatitis."