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.

NASH: A glance at the landscape of pharmacological treatment / Lucia Brodosi; Francesca Marchignoli; Maria Letizia Petroni; Giulio Marchesini. - In: ANNALS OF HEPATOLOGY. - ISSN 1665-2681. - STAMPA. - 15:5(2016), pp. 673-681. [10.5604/16652681.1212318]

NASH: A glance at the landscape of pharmacological treatment

BRODOSI, LUCIA;MARCHIGNOLI, FRANCESCA;Maria Letizia Petroni;MARCHESINI REGGIANI, GIULIO
2016

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.
2016
NASH: A glance at the landscape of pharmacological treatment / Lucia Brodosi; Francesca Marchignoli; Maria Letizia Petroni; Giulio Marchesini. - In: ANNALS OF HEPATOLOGY. - ISSN 1665-2681. - STAMPA. - 15:5(2016), pp. 673-681. [10.5604/16652681.1212318]
Lucia Brodosi; Francesca Marchignoli; Maria Letizia Petroni; Giulio Marchesini
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/567955
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