More pediatric patients with NASH, NAFLD are male, Hispanic than adult patients


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Pediatric patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) are more likely to be male than female, according to a new analysis, which suggests the opposite is true for adult patients. – which indicates a possible change in 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. Gave. NAFLD patients.

The trends observed include major changes in the gender and racial/ethnic composition of younger patients compared to older patients – which the investigators stressed should be investigated further.

The investigators, led by Daniela Castaño, MD, director of the Medical and Scientific Group, Pharmacovigilance Regulatory Affairs and Medical Writing, Clinical Research at Thermo Fisher Scientific, analyzed demographics for gender, race and ethnicity through a 140-million-patient database in 76 countries. US Care Centers will explain trends among NASH and NAFLD patients.

The team took note of recent U.S. Food and Drug Administration (FDA) guidance emphasizing the importance of assessing clinical trial populations that are real-world patient populations for conditions including NASH and NAFLD. Represents populations – a pair of hepatic diseases currently without an FDA-approved drug.

“However, the FDA has not provided specific guidance about how to define trial populations and demographic targets for age groups within those populations,” the investigators wrote.

Castaño and colleagues evaluated demographic data for individuals with a NASH diagnosis or with fatty liver changes not otherwise specified across 4 age groups:

  • <18 years old
  • 18-30 years old
  • 30 – 50 years old
  • >50 years old

The team’s analysis of pediatric patients included 30,050 individuals diagnosed with fatty liver changes and 2,400 individuals diagnosed with NASH. Of pediatric patients with fatty liver changes, 62% were male; Race-reported data showed that 55% were white, 6% were black, 2% were Asian, and 37% were classified as “other or unknown”.

Ethnicity data showed that 44% of patients diagnosed with fatty liver changes were identified as non-Hispanic or Latino; 38% were Hispanic or Latino; 18% were unknown.

Among adults aged 18–30 years, 105,880 individuals with a diagnosis of fatty liver change were identified, as well as 4010 individuals with NASH. The majority of patients suffering from fatty liver changes were women (52%); 65% were white; 8% were black; 3% were Asian; and 24% were “other or unknown”.

In ethnic data of adults aged 18 – 30 years diagnosed with fatty liver disease, 55% identified as non-Hispanic or Latino; 26% were Hispanic or Latino; and 19% were unknown.

Demographic data related to adult patients aged 30–50 years were analyzed but not included in the investigators’ abstract in NASPGHAN 2023.

Among adults aged over 50, 447,070 individuals were identified with a fatty liver transformation diagnosis, and 16,620 individuals were identified with a NASH diagnosis. Again, 52% of patients diagnosed with fatty liver changes were women; Two-thirds (67%) were white; 10% were black; 4% were Asian; and 19% were “other or unknown”.

Regarding ethnicity at diagnosis of fatty liver changes, 62% of older adults were non-Hispanic or Latino; 18% were Hispanic or Latino; and 20% were unknown.

Castaño and colleagues observed significant demographic differences in the NASH and fatty liver disease patient populations across the age groups observed – most relevantly, the predominance of male patients in the pediatric population compared to female patients in the adult population; a larger proportion of Hispanic or Latino patients in the pediatric population; and marked changes in racial and ethnic demographic parameters with increasing age.

The team concluded, “Whether these differences are based on the etiological causes of the disorders in different age groups or whether they result from the historical focus of research on Hispanic male children is unknown.” “The data reiterate that the natural history of NAFLD is not well understood and that there may be factors in pediatric physiology that make the etiological cause of the disease different from adult NAFLD.”

He suggested that future evaluations should try to understand these trends.

Reference

  1. Castaño D, Figueroa P, Blaco S, Vignola A, et al., Changing demographics of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) pediatric populations versus adult populations in a large electronic medical record database. Paper presented at: North American Society for Pediatric Gastroenterology, Hepatology and Nutrition 2023 Annual Meeting; October 4 – 7; San Diego, CA. Accessed October 6, 2023.
  2. Walter K. There is hope on the way for patients with this often neglected, fatty liver disease. HCPLive. Published on March 29, 2023. https://www.hcplive.com/view/often-neglected-hope-fatty-liver-disease-patients

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