Nonalcoholic steatohepatitis and endpoints in clinical trials

William N. Hannah, Dawn M. Torres, Stephen A. Harrison*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

30 Scopus citations

Abstract

Nonalcoholic fatty liver disease (NAFLD) is now the leading cause of liver disease in developed countries, and the rates of NAFLD continue to rise in conjunction with the obesity pandemic. While the majority of patients with isolated steatosis generally have a benign course, a diagnosis of nonalcoholic steatohepatitis (NASH) carries a significantly higher risk for progression of disease, cirrhosis, and death. Pharmacologic therapeutic interventions in NASH have largely proven to be ineffective or unappealing due to long-term side-effect profiles, and the majority of patients cannot achieve or sustain targeted weight loss goals, necessitating an urgent need for therapeutic trials and drug development. The complex molecular mechanisms leading to NASH and the long duration of time to develop complications of disease are challenges to developing meaningful clinical endpoints. Because of these challenges, surrogate endpoints that are linked to all-cause mortality, liver-related death, and complications of cirrhosis are much more likely to be beneficial in the majority of patients.

Original languageEnglish
Pages (from-to)756-763
Number of pages8
JournalGastroenterology and Hepatology
Volume12
Issue number12
StatePublished - Dec 2016
Externally publishedYes

Keywords

  • Cirrhosis
  • Endpoints
  • Nonalcoholic steatohepatitis
  • Surrogate marker

Fingerprint

Dive into the research topics of 'Nonalcoholic steatohepatitis and endpoints in clinical trials'. Together they form a unique fingerprint.

Cite this