Association of changes in histologic severity of nonalcoholic steatohepatitis and changes in patient‐reported quality of life

Abstract Nonalcoholic steatohepatitis (NASH) is a prevalent chronic disease that is associated with a spectrum of liver fibrosis and can lead to cirrhosis. Patients with NASH report lower health‐related quality of life (HRQoL) than the general population. It remains uncertain how changes in histolog...

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Main Authors: Laura Heath, Paul Aveyard, Jeremy W. Tomlinson, Jeremy F. Cobbold, Dimitrios A. Koutoukidis
Format: Article
Language:English
Published: Wolters Kluwer Health/LWW 2022-10-01
Series:Hepatology Communications
Online Access:https://doi.org/10.1002/hep4.2044
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author Laura Heath
Paul Aveyard
Jeremy W. Tomlinson
Jeremy F. Cobbold
Dimitrios A. Koutoukidis
author_facet Laura Heath
Paul Aveyard
Jeremy W. Tomlinson
Jeremy F. Cobbold
Dimitrios A. Koutoukidis
author_sort Laura Heath
collection DOAJ
description Abstract Nonalcoholic steatohepatitis (NASH) is a prevalent chronic disease that is associated with a spectrum of liver fibrosis and can lead to cirrhosis. Patients with NASH report lower health‐related quality of life (HRQoL) than the general population. It remains uncertain how changes in histologic severity are associated with changes in HRQoL. This is a secondary analysis of the Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment (FLINT) and Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis (PIVENS) randomized controlled trials in patients with biopsy‐proven NASH. HRQoL was assessed using short form‐36 at baseline and at follow‐up biopsy (at 72 and 96 weeks, respectively). Adjusted linear regression models were used to examine the association between changes in liver fibrosis (primary analysis), nonalcoholic fatty liver disease (NAFLD) activity score (secondary analysis), and changes in HRQoL scores. Compared with stable fibrosis, improvement of fibrosis by at least one stage was significantly associated with improvements only in the physical function component by 1.8 points (95% confidence interval, 0.1, 3.5). Worsening of fibrosis by at least one stage was not associated with statistically significant changes in any HRQoL domain compared with stable fibrosis. Associations between HRQoL and NAFLD disease activity score in the secondary analysis were of similar magnitude. Weight loss was associated with small improvements in physical function, general health, and energy levels. Conclusion: Improvements in fibrosis stage were associated with improvements in the physical component of HRQoL, but the clinical impact was modest. As improving fibrosis may not meaningfully improve well‐being, treatment for NASH will be cost effective only if it prevents long‐term hepatic and cardiovascular disease.
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spelling doaj.art-cffea5b7f47e456f8751b274991ee4172023-08-02T06:29:48ZengWolters Kluwer Health/LWWHepatology Communications2471-254X2022-10-016102623263310.1002/hep4.2044Association of changes in histologic severity of nonalcoholic steatohepatitis and changes in patient‐reported quality of lifeLaura Heath0Paul Aveyard1Jeremy W. Tomlinson2Jeremy F. Cobbold3Dimitrios A. Koutoukidis4Nuffield Department of Primary Care Health Sciences University of Oxford Oxford UKNuffield Department of Primary Care Health Sciences University of Oxford Oxford UKOxford Centre for Diabetes Endocrinology and Metabolism NIHR Oxford Biomedical Research Centre University of Oxford Churchill Hospital Oxford UKDepartment of Gastroenterology and Hepatology NIHR Oxford Biomedical Research Centre Oxford University Hospitals NHS Foundation Trust John Radcliffe Hospital Oxford UKNuffield Department of Primary Care Health Sciences University of Oxford Oxford UKAbstract Nonalcoholic steatohepatitis (NASH) is a prevalent chronic disease that is associated with a spectrum of liver fibrosis and can lead to cirrhosis. Patients with NASH report lower health‐related quality of life (HRQoL) than the general population. It remains uncertain how changes in histologic severity are associated with changes in HRQoL. This is a secondary analysis of the Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment (FLINT) and Pioglitazone, Vitamin E, or Placebo for Nonalcoholic Steatohepatitis (PIVENS) randomized controlled trials in patients with biopsy‐proven NASH. HRQoL was assessed using short form‐36 at baseline and at follow‐up biopsy (at 72 and 96 weeks, respectively). Adjusted linear regression models were used to examine the association between changes in liver fibrosis (primary analysis), nonalcoholic fatty liver disease (NAFLD) activity score (secondary analysis), and changes in HRQoL scores. Compared with stable fibrosis, improvement of fibrosis by at least one stage was significantly associated with improvements only in the physical function component by 1.8 points (95% confidence interval, 0.1, 3.5). Worsening of fibrosis by at least one stage was not associated with statistically significant changes in any HRQoL domain compared with stable fibrosis. Associations between HRQoL and NAFLD disease activity score in the secondary analysis were of similar magnitude. Weight loss was associated with small improvements in physical function, general health, and energy levels. Conclusion: Improvements in fibrosis stage were associated with improvements in the physical component of HRQoL, but the clinical impact was modest. As improving fibrosis may not meaningfully improve well‐being, treatment for NASH will be cost effective only if it prevents long‐term hepatic and cardiovascular disease.https://doi.org/10.1002/hep4.2044
spellingShingle Laura Heath
Paul Aveyard
Jeremy W. Tomlinson
Jeremy F. Cobbold
Dimitrios A. Koutoukidis
Association of changes in histologic severity of nonalcoholic steatohepatitis and changes in patient‐reported quality of life
Hepatology Communications
title Association of changes in histologic severity of nonalcoholic steatohepatitis and changes in patient‐reported quality of life
title_full Association of changes in histologic severity of nonalcoholic steatohepatitis and changes in patient‐reported quality of life
title_fullStr Association of changes in histologic severity of nonalcoholic steatohepatitis and changes in patient‐reported quality of life
title_full_unstemmed Association of changes in histologic severity of nonalcoholic steatohepatitis and changes in patient‐reported quality of life
title_short Association of changes in histologic severity of nonalcoholic steatohepatitis and changes in patient‐reported quality of life
title_sort association of changes in histologic severity of nonalcoholic steatohepatitis and changes in patient reported quality of life
url https://doi.org/10.1002/hep4.2044
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