Histological Endpoints for Nonalcoholic Steatohepatitis Trials: Lights and Shadows.
Semin Liver Dis
; 40(4): 339-345, 2020 11.
Article
em En
| MEDLINE
| ID: mdl-32906165
ABSTRACT
Nonalcoholic steatohepatitis (NASH) with liver fibrosis is an increasingly important cause of liver-related morbidity and mortality. A diagnosis of NASH can only be made using liver biopsy. Liver histology also forms the endpoint for the expedited licensing strategies that have been approved by regulators to allow patients with NASH access to treatment before the impact of these on clinical outcomes is known. Validation of these histological surrogate endpoints is critical for the ongoing development of new therapies for NASH. The use of liver biopsy to define both trial entry and endpoints raises questions about the use of treatments for NASH in practice when the effectiveness of treatment will likely depend, at least in part, on the use of histology for patient selection in the real world.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Hepatopatia Gordurosa não Alcoólica
Tipo de estudo:
Diagnostic_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article