Preferable effects of pemafibrate on liver function and fibrosis in subjects with type 2 diabetes complicated with liver damage.

Abstract

BACKGROUND:

Pemafibrate has been reported to ameliorate lipid profiles and liver dysfunction. However, which patients derive benefit from the hepatoprotective effects of pemafibrate is unclear.

METHODS:

We conducted a sub-analysis of the PARM-T2D study where subjects with type 2 diabetes complicated by hypertriglyceridemia were prospectively treated with pemafibrate or conventional therapies for 52 weeks. From the original cohort, subjects who had metabolic-associated fatty liver disease without changing their treatment regimens for comorbidities were analyzed. Eligible subjects (n = 293) (average age 61.2 ± 11.7 years, 37.5% female) treated with pemafibrate (pemafibrate, n = 152) or controls who did not change their treatment regimens (controls, n = 141) were divided into three groups based on their alanine aminotransferase (ALT) levels: ALT ≤ upper normal limit (UNL) (pemafibrate, n = 65; controls, n = 50), UNL < ALT ≤ 2×UNL (pemafibrate, n = 58; controls, n = 54), and 2×UNL < ALT (pemafibrate, n = 29; controls, n = 27).

RESULTS:

Pemafibrate treatment significantly ameliorated ALT levels (from 29 to 22 U/L, p < 0.001 by Wilcoxon's signed-rank test) in the total cohort and subjects with high ALT levels (2×ULN < ALT), and improved liver fibrosis as assessed by the Fibrosis-4 index (mean change - 0.05 (95% confidence interval: -0.22 to - 0.02), p < 0.05 versus baseline by the Mann-Whitney U-test and p < 0.05 versus the ALT ≤ UNL group by the Kruskal-Wallis test followed by Dunn's post-hoc analysis).

CONCLUSIONS:

The hepatoprotective effects of pemafibrate were dominant in subjects with type 2 diabetes complicated with liver dysfunction.

TRIAL REGISTRATION:

This study was registered with the University Hospital Medical Information Network Center Clinical Trials Registry (UMIN000037385).

• Authors: Hiroshi Nomoto, Kenichi Kito, Hiroshi Iesaka, Takahisa Handa, Shingo Yanagiya, Aika Miya, Hiraku Kameda, Kyu Yong Cho, Jun Takeuchi, So Nagai, Ichiro Sakuma, Akinobu Nakamura, Tatsuya Atsumi
• Journal: Diabetology & metabolic syndrome (Diabetol Metab Syndr) Vol. 15 Issue 1 Pg. 214 (Oct 26 2023) ISSN: 1758-5996 [Print] England
• PMID: 37880780 (Publication Type: Journal Article)
• Copyright: © 2023. BioMed Central Ltd., part of Springer Nature.