Source/Disclosures
Disclosures: Stavra reports receiving grants from Axcella Health and Target PharmaSolutions and receives royalties from UptoDate. Please see the study for all other authors’ relevant financial disclosures.
July 23, 2020
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Standard of care lifestyle counseling improves NASH, fibrosis in children with NAFLD

Source/Disclosures
Disclosures: Stavra reports receiving grants from Axcella Health and Target PharmaSolutions and receives royalties from UptoDate. Please see the study for all other authors’ relevant financial disclosures.
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Standard of care lifestyle counseling correlated with improvements in nonalcoholic steatohepatitis or fibrosis in half of the children with nonalcoholic fatty liver, according to study results publish in Gastroenterology.

However, investigators observed continual progression in more than one-third of children within 2 years.

Standard of care lifestyle counseling correlated with improvements in nonalcoholic steatohepatitis or fibrosis in half of the children with nonalcoholic fatty liver.

“The high incidence of type 2 diabetes, and its strong relationship to fibrosis progression, underscores the urgent need to assess longer-term outcomes,” Stavra A. Xanthakos, MD, from the division of gastroenterology, hepatology and nutrition at Cincinnati Children’s Hospital Medical Center and the department of pediatrics at the University of Cincinnati College of Medicine in Cincinnati, Ohio, and colleagues wrote. “Trials of novel therapies are urgently needed to identify efficacious and accessible interventions for children failing to respond to lifestyle counseling.”

In two double-blind, randomized clinical trials, Xanthakos and colleagues compared placebo with standard of care lifestyle counseling in 122 children with NAFLD from the NASH clinical research network. Histologic changes were evaluated with regression analysis regarding baseline and longitudinal changes in clinical variables.

“At enrollment, 31% of the children had definite NASH, 34% had borderline zone 1 NASH, 13% had borderline zone 3 NASH, and 21% had fatty liver but not NASH,” the investigators wrote. “Over a mean time period of [1.6] years, borderline or definite NASH resolved in 29% of the children, whereas 18% of the children with fatty liver or borderline NASH developed definite NASH.”

Results showed improvements in fibrosis in 34% of children; however, fibrosis worsened in 23%. Investigators noted progression to definite NASH or fibrosis was reported in 36% of children and both were observed in 11% of children. NASH or fibrosis improvements occurred in 52% of children and 20% of children saw improvements in both. Type 2 diabetes developed in 5% of children. Adolescent age, higher waist circumference, levels of alanine or aspartate aminotransferase, total and LDL cholesterol at baseline, increasing level of alanine aminotransferase, HbA1C (P < .05) were correlated with progression to NASH and/or fibrosis.

Other factors correlated with progression to NASH and/or fibrosis were increasing level of gamma-glutamyl transferase and development of type 2 diabetes (P < .01). Increased gamma-glutamyl transferase correlated with decreased odds for improvement (P = .003).