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Clinical and metabolic effects associated with weight changes and obeticholic acid in non-alcoholic steatohepatitis.

Publication ,  Journal Article
Hameed, B; Terrault, NA; Gill, RM; Loomba, R; Chalasani, N; Hoofnagle, JH; Van Natta, ML; NASH CRN,
Published in: Aliment Pharmacol Ther
March 2018

BACKGROUND: In a 72-week, randomised controlled trial of obeticholic acid (OCA) in non-alcoholic steatohepatitis (NASH), OCA was superior to placebo in improving serum ALT levels and liver histology. OCA therapy also reduced weight. AIMS: Because weight loss by itself can improve histology, to perform a post hoc analysis of the effects of weight loss and OCA treatment in improving clinical and metabolic features of NASH. METHODS: 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. RESULTS: Weight loss occurred in 44% (45/102) of OCA and 32% (31/98) of placebo-treated patients (P = 0.08). The NAFLD Activity score (NAS) improved more in those with than without weight loss in both the OCA- (-2.4 vs -1.2, P<0.001) and placebo-treated patients (-1.2 vs -0.5, P = 0.03). ALT levels also improved in those with vs without weight loss in OCA- (-43 vs -34 U/L, P = 0.12) and placebo-treated patients (-29 vs -10 U/L, P = 0.02). However, among those who lost weight, OCA was associated with opposite effects from placebo on changes in alkaline phosphatase (+21 vs -12 U/L, P<0.001), total (+13 vs -14 mg/dL, P = 0.02) and LDL cholesterol (+18 vs -12 mg/dL, P = 0.01), and HbA1c (+0.1 vs -0.4%, P = 0.01). CONCLUSIONS: OCA leads to weight loss in up to 44% of patients with NASH, and OCA therapy and weight loss have additive benefits on serum aminotransferases and histology. However, favourable effects of weight loss on alkaline phosphatase, lipids and blood glucose seen in placebo-treated patients were absent or reversed on OCA treatment. These findings stress the importance of assessing concomitant metabolic effects of new therapies of NASH. Clinical trial number: NCT01265498.

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Published In

Aliment Pharmacol Ther

DOI

EISSN

1365-2036

Publication Date

March 2018

Volume

47

Issue

5

Start / End Page

645 / 656

Location

England

Related Subject Headings

  • Weight Loss
  • Treatment Outcome
  • Non-alcoholic Fatty Liver Disease
  • Middle Aged
  • Male
  • Humans
  • Gastroenterology & Hepatology
  • Female
  • Double-Blind Method
  • Cholesterol, LDL
 

Citation

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Hameed, B., Terrault, N. A., Gill, R. M., Loomba, R., Chalasani, N., Hoofnagle, J. H., … NASH CRN, . (2018). Clinical and metabolic effects associated with weight changes and obeticholic acid in non-alcoholic steatohepatitis. Aliment Pharmacol Ther, 47(5), 645–656. https://doi.org/10.1111/apt.14492
Hameed, B., N. A. Terrault, R. M. Gill, R. Loomba, N. Chalasani, J. H. Hoofnagle, M. L. Van Natta, and M. L. NASH CRN. “Clinical and metabolic effects associated with weight changes and obeticholic acid in non-alcoholic steatohepatitis.Aliment Pharmacol Ther 47, no. 5 (March 2018): 645–56. https://doi.org/10.1111/apt.14492.
Hameed B, Terrault NA, Gill RM, Loomba R, Chalasani N, Hoofnagle JH, et al. Clinical and metabolic effects associated with weight changes and obeticholic acid in non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2018 Mar;47(5):645–56.
Hameed, B., et al. “Clinical and metabolic effects associated with weight changes and obeticholic acid in non-alcoholic steatohepatitis.Aliment Pharmacol Ther, vol. 47, no. 5, Mar. 2018, pp. 645–56. Pubmed, doi:10.1111/apt.14492.
Hameed B, Terrault NA, Gill RM, Loomba R, Chalasani N, Hoofnagle JH, Van Natta ML, NASH CRN. Clinical and metabolic effects associated with weight changes and obeticholic acid in non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2018 Mar;47(5):645–656.
Journal cover image

Published In

Aliment Pharmacol Ther

DOI

EISSN

1365-2036

Publication Date

March 2018

Volume

47

Issue

5

Start / End Page

645 / 656

Location

England

Related Subject Headings

  • Weight Loss
  • Treatment Outcome
  • Non-alcoholic Fatty Liver Disease
  • Middle Aged
  • Male
  • Humans
  • Gastroenterology & Hepatology
  • Female
  • Double-Blind Method
  • Cholesterol, LDL