Clinical Outcomes in NASH: Choosing the Right Endpoints

Non-alcoholic steatohepatitis (NASH) can lead to serious conditions such as cirrhosis and its complications, liver cancer and hepatic transplantation. Many patients eventually die from liver-related problems or cardiovascular disease. The challenge in developing drugs for NASH is to demonstrate an improvement in clinical outcomes. Cirrhosis takes several years to develop, and it is impractical to perform such long studies to identify treatment benefits. Therefore, to expedite the process and deliver new drugs to patients, biopharmaceutical companies have to consider surrogate endpoints that are reliable, can be obtained within a reasonable amount of time and are associated with progression of the disease.

A range of liver-related outcomes

NASH patients face many potential disorders and complications. In addition to overall death and liver-related mortality, the following endpoints should be evaluated in a clinical Clinical Outcomes in NASHoutcomes study:

  • Portal hypertension. Chronic injury to the liver results in a wounding response that leads to fibrosis, scarring and ultimately replacement of normal liver architecture with regenerative nodules. As a result of these changes, portal hypertension develops.
  • The accumulation of fluid in the abdomen results from portal hypertension. Using diuretics and reducing sodium intake often helps, but some cases are difficult to treat.

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