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Preferable effects of pemafibrate on liver function and fibrosis in subjects with type 2 diabetes complicated with liver damage
oleh: 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
Format: | Article |
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Diterbitkan: | BMC 2023-10-01 |
Deskripsi
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).