NASH: A glance at the landscape of pharmacological treatment

Ann Hepatol. 2016 Sep-Oct;15(5):673-81. doi: 10.5604/16652681.1212318.

Abstract

The role of nonalcoholic fatty liver disease, namely nonalcoholic steatohepatitis (NASH), as risk factor for liver- and non-liver-related morbidity and mortality has been extensively reported. In addition to lifestyle changes, capable of removing the metabolic factors driving disease progression, there is an urgent need for drugs able to reduce hepatic necroinflammation without worsening of fibrosis. This goal is considered by regulatory agencies as surrogate marker to define the effectiveness in pharmacological compounds in NASH, and fast-track approval was granted by the Food and Drug Administration in consideration of disease severity and unmet medical needs. Several compounds are in the pipeline of pharmaceutical industries and are being studied in phase II trials, but only a few (obeticholic acid, elafibranor) have started phase III trials. This concise review is intended to offer a systematic analysis of the most promising therapeutic intervention in NASH. In conclusion, there is reasonable expectation that drug may help curb the burden of NASH, and we look forward to obtaining solid data on their long-term safety and effectiveness. However, we should not forget that behavioral interventions remain a mandatory background treatment, able to stop disease progression in compliant overweight/ obese patients, with results that compare favorably with - and add to - the beneficial effects of drug treatment.

Publication types

  • Review

MeSH terms

  • Animals
  • Drugs, Investigational / adverse effects
  • Drugs, Investigational / therapeutic use*
  • Humans
  • Life Style
  • Liver / drug effects*
  • Liver / metabolism
  • Liver / pathology
  • Molecular Targeted Therapy
  • Non-alcoholic Fatty Liver Disease / diagnosis
  • Non-alcoholic Fatty Liver Disease / drug therapy*
  • Non-alcoholic Fatty Liver Disease / epidemiology
  • Non-alcoholic Fatty Liver Disease / metabolism
  • Risk Factors
  • Risk Reduction Behavior
  • Treatment Outcome

Substances

  • Drugs, Investigational