A practical use of noninvasive tests in clinical practice to identify high‐risk patients with nonalcoholic steatohepatitis

Abstract

Summary Background Patients with nonalcoholic fatty liver disease (NAFLD) with type 2 diabetes (T2D) or other components of metabolic syndrome are at high risk for disease progression. We proposed an algorithm to identify high‐risk NAFLD patients in clinical practice using noninvasive tests (NITs). Methods Evidence about risk stratification of NAFLD using validated NITs was reviewed by a panel of NASH Experts. Using the most recent evidence regarding the performance of NITs and their application in clinical practice were used to develop an easy‐to‐use algorithm for risk stratification of NAFLD patients seen in primary care, endocrinology and gastroenterology practices. Results The proposed algorithm uses a three‐step process to identify NAFLD patients who are potentially at high risk for adverse outcomes. The first step is to use clinical data to identify most patients who are at risk for having potentially progressive NAFLD (e.g. having T2D or multiple components of metabolic syndrome). The second step is to calculate the FIB‐4 score as a NIT that can further risk stratifying individuals who are at low risk for progressive liver disease and can be managed by their primary healthcare providers to manage their cardiometabolic comorbidities. The third step is to use second‐line NITs (transient elastography or enhanced liver fibrosis tests) to identify those who at high risk for progressive liver disease and should be considered for specially care by providers with NASH expertise. Conclusions The use of this simple clinical algorithm can identify and assist in managing patients with NAFLD at high risk for adverse outcomes.

Diabetes and cirrhosis: Current concepts on diagnosis and management

“…With a rapid increase in the region’s prevalence of diabetes, in 2020 the Latin American Association for the study of the liver (ALEH) practice guidance recommended screening for NASH and liver fibrosis in patients with T2DM 102. Screening efforts in primary care have galvanized around clinical care pathways developed by multidisciplinary teams of experts from primary care, endocrinology, diabetes, obesity management, nutritionists, and hepatologists, aimed at identifying patients for referral to the specialist to avert future cirrhosis 12,13,96,99–103,110. Recommendations supported screening with FIB-4 for all high-risk patients (ie, with obesity/metabolic syndrome, T2DM, elevated plasma aminotransferases, and/or steatosis), followed by transient elastography if the FIB-4 index suggested an intermediate to high risk of clinically significant fibrosis.…”

Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis

“…Non‐invasive identification of patients with NASH is a key focus of this trial. The presence of metabolic risk factors combined with non‐invasive testing performed in sequential order (vibration‐controlled transient elastography [VCTE] and controlled attenuation parameter [CAP]; magnetic resonance elastography [MRE], if available at the study site; and MRI‐PDFF) identifies patients presumed to have NASH 14–16 . In addition to the three double‐blind arms (resmetirom 80 mg, resmetirom 100 mg, placebo), MAESTRO‐NAFLD‐1 includes three open‐label arms in patients with (1) non‐cirrhotic NASH (100 mg), (2) well‐compensated NASH cirrhosis (80 mg starting dose) and (3) moderate renal impairment.…”

“…The presence of metabolic risk factors combined with non-invasive testing performed in sequential order (vibration-controlled transient elastography [VCTE] and controlled attenuation parameter [CAP]; magnetic resonance elastography [MRE], if available at the study site; and MRI-PDFF) identifies patients presumed to have NASH. [14][15][16] In addition to MAESTRO-NAFLD-OLE (NCT04951219) is a 52-week active treatment extension of MAESTRO NAFLD-1 and includes a 12-week double-blind run-in period in which patients are randomised to 80 or 100 mg of resmetirom. After week 12, all patients receive 100 mg of resmetirom for the duration of the trial (Figure 1B).…”

How to Identify Advanced Nonalcoholic Fatty Liver Disease in the Primary Care Setting

“…To help with this risk stratification, several algorithms have been proposed. 12,[66][67][68][69][70][71] The majority of these algorithms have initially focused on clinical risk factors of progression, including the presence of T2D or two other components of metabolic syndrome as well as those with chronically elevated aminotransferases. Once the population is enriched with those with metabolic risk factors, FIB-4 index has been recommended as the first-line NIT.…”