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An analysis of age-stratified fatty liver disease patient demographics show a surprising shift in racial/ethnic and sex trends among children and adolescents.
Pediatric patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH) are more likely to be male than female, according to new analysis that which additionally points out the opposite is true for adult patients—indicating a potential shift in the demographic trends of NAFLD and NASH in the next generation of patients.
In research presented in an abstract at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) 2023 Annual Meeting in San Diego this week, a multinational team of investigators reported on “unexpected demographic observations” across 4 current age groups of NASH and NAFLD patients.
Among the observed trends are major shifts in sex and race/ethnic compositions of younger patients than older patients—that which investigators stressed needs to be investigated further.
Led by Daniela Castano, MD, of the Medical and Scientific Group, Pharmacovigilance Regulatory Affairs and Medical Writing, Clinical Research at Thermo Fisher Scientific, investigators conducted an analysis of the demographics for gender, race and ethnicity via a 140 million-patient database across 76 US care centers to interpret trends among NASH and NAFLD patients.
The team noted a recent US Food and Drug Administration (FDA) guidance stressing the importance of assessing clinical trial populations that represent real-world patient populations for conditions including NASH and NAFLD—a pair of hepatic diseases currently without an FDA-approved drug.
“However, the FDA has not provided specific guidance on how to define demographic goals for trial populations and age cohorts within those populations,” investigators wrote.
Castano and colleagues assessed demographic data for individuals with a NASH diagnosis or with fatty liver changes not elsewhere specified across 4 age groups:
The team’s analysis of pediatric patients included 30,050 individuals with a diagnosis of fatty liver changes and 2400 with a diagnosis of NASH. Among pediatric patients with fatty live changes 62% were male; race-reported data showed 55% were White, 6% were Black, 2% were Asian, and 37% were classified as “other or unknown.”
Ethnicity data showed that 44% of patients with fatty liver changes diagnoses were identified as non-Hispanic or Latino; 38% were Hispanic or Latino; 18% were unknown.
Among adults aged 18 - 30 years old, 105,880 individuals with a fatty liver changes diagnosis were identified, as well as 4010 with NASH. A slight majority of patients with fatty liver changes diagnoses were female (52%); 65% were White; 8% were Black; 3% were Asian; and 24% were “other or unknown.”
Across ethnicity data for adults aged 18 - 30 years old with fatty liver changes diagnoses, 55% were identified as non-Hispanic or Latino; 26% were Hispanic or Latino; and 19% were unknown.
Demographic data regarding adult patients aged 30 - 50 years were analyzed but not included in the investigators’ abstract at NASPGHAN 2023.
Among adults aged >50, 447,070 individuals were identified with a fatty liver changes diagnosis, and 16,620 individuals with a NASH diagnosis. Again, 52% of patients with fatty liver changes diagnoses were female; two-thirds (67%) were White; 10% were Black; 4% were Asian; and 19% were “other or unknown.”
Regarding ethnicity for fatty liver changes diagnoses, 62% of older adults were non-Hispanic or Latino; 18% were Hispanic or Latino; and 20% were unknown.
Castano and colleagues noted significant demographic differentiations across the NASH and fatty liver disease patient populations across the observed age groups—most pertinently, the predominance of male patients in the pediatric population versus female patients in the adult population; the greater proportion of Hispanic or Latino patients in the pediatric population; and the discernible change in race and ethnic demographic parameters correlating with increased age.
“Whether these differences are based on the etiological causes of the disorders in different age groups or if they result from a historical focus of research on Hispanic male children remains unknown,” the team concluded. “The data reiterates that the natural history of NAFLD is not well understood and there may be factors in pediatric physiology that make the etiological cause of the disease different from adult NAFLD.”
They recommended future assessment seek understanding into these trends.