Among patients screened for metabolic dysfunction-associated steatotic liver disease (MASLD) clinical trials, 11% had phosphatidylethanol (PEth) results of 20 ng/mL or higher, indicating a potential need for further clinical evaluation for possible metabolic dysfunction and alcohol-associated liver disease (MetALD) or alcohol-associated liver disease (ALD).
Dr. Noureddin and colleagues analyzed a prospective, multicenter cohort to investigate the incidence of increased PEth and the efficacy of this measurement to categorize patients in clinical trials as having either dominant MASLD or MetALD/ALD phenotypes.
Using a multicenter database of patients screened for clinical trials with MASLD pharmaceutical therapies, the study team identified and included those with PEth results (n=2,870).
Patients with higher PEth results had elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT; all P<0.001).
In multivariate analysis, PEth results of 20 ng/mL or greater were associated with higher GGT (per 10 U/L; adjusted odds ratio [aOR], 1.04; P<0.001) and lower HbA1c (aOR, 0.68; P<0.001).
Among patients screened for metabolic dysfunction-associated steatotic liver disease (MASLD) clinical trials, 11% had phosphatidylethanol (PEth) results of 20 ng/mL or higher, indicating a potential need for further clinical evaluation for possible metabolic dysfunction and alcohol-associated liver disease (MetALD) or alcohol-associated liver disease (ALD).
Mazen Noureddin, MD, Houston Methodist Hospital, Houston, Texas, and colleagues explained the importance of “accurate distinction between metabolic dysfunction-associated steatotic liver disease MASLD, ALD, and the overlap MetALD.” As alcohol use may be underreported in surveys, PEth results have emerged as a tool to rule out MetALD and ALD in clinical trial enrollments. Dr. Noureddin and colleagues analyzed a prospective, multicenter cohort to investigate the incidence of increased PEth and the efficacy of this measurement to categorize patients in clinical trials as having either dominant MASLD or MetALD/ALD phenotypes.
Using a multicenter database of patients screened for clinical trials with MASLD pharmaceutical therapies, the study team identified and included those with PEth results (n=2,870). Patients were stratified into groups based on alcohol intake: low for those with greater than 20 ng/mL (n=2,560, 89%), moderate for those with 20 to 100 ng/mL (n=168, 6%), and high for those with 100 ng/mL or greater (n=142, 5%). Of those in the high group, 92 had PEth ≥200 ng/mL.
Patients with higher PEth results had elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT; all P<0.001). Additionally, those with lower PEth were more likely to have higher hemoglobin A1c (HbA1c; P<0.001). In multivariate analysis, PEth results of 20 ng/mL or greater were associated with higher GGT (per 10 U/L; adjusted odds ratio [aOR], 1.04; P<0.001) and lower HbA1c (aOR, 0.68; P<0.001).
As 11% of this cohort of patients screened for MASLD clinical trials had PEth results of 20 ng/mL or greater, Dr. Noureddin and colleagues said this suggests “a level of alcohol consumption that may warrant further clinical evaluation for possible MetALD or ALD.”
