This multicenter prospective cohort study evaluated the prevalence of elevated phosphatidylethanol (PEth) and its ability to distinguish MASLD from MetALD/ALD among 2,870 patients screened for MASLD pharmacologic clinical trials, stratifying by low (<20 ng/mL), moderate (20–<100 ng/mL), and high (≥100 ng/mL) PEth levels.
11% of screened patients had PEth ≥20 ng/mL (6% moderate, 5% high); elevated PEth correlated with higher GGT (aOR 1.04 per 10 U/L, 95% CI 1.03–1.06) and lower HbA1c (aOR 0.68, 95% CI 0.60–0.78), while indeterminate FIB-4 scores were more common in the high PEth group (all p<0.001).
Self-reported alcohol use was not formally compared to PEth results, limiting direct assessment of underreporting. The cohort is a clinical trial screening population, which may not represent routine clinical practice. No biopsy or imaging data are reported to confirm ALD vs. MASLD diagnosis.
In MASLD clinical trial screening, about 1 in 9 patients had PEth ≥20 ng/mL, signaling possible MetALD or ALD. Clinicians should consider routine PEth testing—especially when GGT is elevated or HbA1c is lower than expected—to avoid misclassifying ALD as MASLD.
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