Effect of Pemafibrate on Metabolic Dysfunction-Associated Steatotic Liver Disease: A Nationwide Multicenter Study.

AIM

Although pemafibrate, a selective peroxisome proliferator-activated receptor α (PPARα) modulator primarily prescribed for hypertriglyceridemia, may improve liver function in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), its efficacy has not been sufficiently evaluated. This study aimed to assess the effect of pemafibrate on liver function in patients with MASLD using a nationwide multicenter cohort.

METHODS

In this nationwide multicenter study, we analyzed 352 patients diagnosed with MASLD and hypertriglyceridemia who newly initiated pemafibrate therapy. The primary outcome was the rate of ALT normalization (ALT ≤ 30 U/L). Laboratory data were collected at baseline and 3, 6, and 12 months after pemafibrate initiation, and longitudinal changes were evaluated.

RESULTS

The mean ALT levels decreased significantly from 60.1 ± 1.8 U/L at baseline to 44.9 ± 1.4, 41.6 ± 1.3, and 38.1 ± 1.3 U/L at 3, 6, and 12 months, respectively (all  < 0.001). The ALT normalization rate increased from 30.4% at baseline to 46.0%, 50.9%, and 56.6% at 3, 6, and 12 months ( < 0.001), respectively, with marked improvement at three months and maintenance throughout follow-up.

CONCLUSIONS

Pemafibrate treatment significantly improved ALT levels and ALT normalization rates in MASLD patients with hypertriglyceridemia, with improvement observed at three months and a sustained effect up to 12 months. This is a large-scale multicenter study to date evaluating pemafibrate in MASLD, providing robust evidence for its potential as a therapeutic option in this population.