Effectiveness of Pemafibrate Dose Escalation on Metabolic Dysfunction-Associated Steatotic Liver Disease Refractory to Standard Dose
<b>Background and Aim:</b> Controlling the hepatic inflammation of metabolic dysfunction-associated steatotic liver disease (MASLD) is important to prevent serious condition. Pemafibrate, a selective peroxisome proliferator-activated receptor-α modulator, has demonstrated effectiveness a...
Saved in:
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2025-02-01
|
| Series: | Metabolites |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2218-1989/15/2/100 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850080631855251456 |
|---|---|
| author | Satoshi Shinozaki Kouichi Miura Toshiyuki Tahara Hironori Yamamoto |
| author_facet | Satoshi Shinozaki Kouichi Miura Toshiyuki Tahara Hironori Yamamoto |
| author_sort | Satoshi Shinozaki |
| collection | DOAJ |
| description | <b>Background and Aim:</b> Controlling the hepatic inflammation of metabolic dysfunction-associated steatotic liver disease (MASLD) is important to prevent serious condition. Pemafibrate, a selective peroxisome proliferator-activated receptor-α modulator, has demonstrated effectiveness at a standard dose (0.2 mg daily). The aim of this study is to evaluate the effectiveness of pemafibrate dose escalation from 0.2 mg to 0.4 mg daily in patients with MASLD who are refractory to standard-dose therapy. <b>Methods:</b> This study included patients with MASLD who had a persistent elevation of alanine aminotransferase (ALT) levels despite more than one year of standard-dose pemafibrate therapy (0.2 mg daily). All patients underwent dose escalation to 0.4 mg once daily. Hepatic inflammation was assessed using serum ALT levels, hepatic function was evaluated with the albumin–bilirubin score, and hepatic fibrosis was estimated using Mac-2 binding protein glycosylation isomer (M2BPGi) levels. A one-year treatment period was investigated, including six months before dose escalation and six months after dose escalation. <b>Results:</b> Eleven patients were included. The median treating period with standard-dose pemafibrate was 3.2 years. Weight did not show significant change throughout the observation period. Regarding the hepatobiliary enzyme, the aspartate aminotransferase, ALT, and γ-glutamyl transpeptidase levels significantly improved six months after the dose escalation. Specifically, ALT improved in all patients, and the ALT levels normalized in four patients (36%). The lipid profiles, the albumin–bilirubin score, and M2BPGi did not significantly change after the dose escalation. <b>Conclusions:</b> The dose escalation of pemafibrate from 0.2 mg to 0.4 mg daily may improve hepatic inflammation in patients with MASLD refractory to standard-dose therapy. |
| format | Article |
| id | doaj-art-dbca4a8f19cc441fb3ec9dc311b0de1c |
| institution | DOAJ |
| issn | 2218-1989 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Metabolites |
| spelling | doaj-art-dbca4a8f19cc441fb3ec9dc311b0de1c2025-08-20T02:44:53ZengMDPI AGMetabolites2218-19892025-02-0115210010.3390/metabo15020100Effectiveness of Pemafibrate Dose Escalation on Metabolic Dysfunction-Associated Steatotic Liver Disease Refractory to Standard DoseSatoshi Shinozaki0Kouichi Miura1Toshiyuki Tahara2Hironori Yamamoto3Shinozaki Medical Clinic, Utsunomiya 321-3223, JapanDepartment of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke 329-0431, JapanSaiseikai Utsunomiya Hospital, Utsunomiya 321-0974, JapanDepartment of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke 329-0431, Japan<b>Background and Aim:</b> Controlling the hepatic inflammation of metabolic dysfunction-associated steatotic liver disease (MASLD) is important to prevent serious condition. Pemafibrate, a selective peroxisome proliferator-activated receptor-α modulator, has demonstrated effectiveness at a standard dose (0.2 mg daily). The aim of this study is to evaluate the effectiveness of pemafibrate dose escalation from 0.2 mg to 0.4 mg daily in patients with MASLD who are refractory to standard-dose therapy. <b>Methods:</b> This study included patients with MASLD who had a persistent elevation of alanine aminotransferase (ALT) levels despite more than one year of standard-dose pemafibrate therapy (0.2 mg daily). All patients underwent dose escalation to 0.4 mg once daily. Hepatic inflammation was assessed using serum ALT levels, hepatic function was evaluated with the albumin–bilirubin score, and hepatic fibrosis was estimated using Mac-2 binding protein glycosylation isomer (M2BPGi) levels. A one-year treatment period was investigated, including six months before dose escalation and six months after dose escalation. <b>Results:</b> Eleven patients were included. The median treating period with standard-dose pemafibrate was 3.2 years. Weight did not show significant change throughout the observation period. Regarding the hepatobiliary enzyme, the aspartate aminotransferase, ALT, and γ-glutamyl transpeptidase levels significantly improved six months after the dose escalation. Specifically, ALT improved in all patients, and the ALT levels normalized in four patients (36%). The lipid profiles, the albumin–bilirubin score, and M2BPGi did not significantly change after the dose escalation. <b>Conclusions:</b> The dose escalation of pemafibrate from 0.2 mg to 0.4 mg daily may improve hepatic inflammation in patients with MASLD refractory to standard-dose therapy.https://www.mdpi.com/2218-1989/15/2/100non-alcoholic fatty liver diseasenon-alcoholic steatohepatitispemafibratedyslipidemiametabolic dysfunction-associated steatotic liver disease |
| spellingShingle | Satoshi Shinozaki Kouichi Miura Toshiyuki Tahara Hironori Yamamoto Effectiveness of Pemafibrate Dose Escalation on Metabolic Dysfunction-Associated Steatotic Liver Disease Refractory to Standard Dose Metabolites non-alcoholic fatty liver disease non-alcoholic steatohepatitis pemafibrate dyslipidemia metabolic dysfunction-associated steatotic liver disease |
| title | Effectiveness of Pemafibrate Dose Escalation on Metabolic Dysfunction-Associated Steatotic Liver Disease Refractory to Standard Dose |
| title_full | Effectiveness of Pemafibrate Dose Escalation on Metabolic Dysfunction-Associated Steatotic Liver Disease Refractory to Standard Dose |
| title_fullStr | Effectiveness of Pemafibrate Dose Escalation on Metabolic Dysfunction-Associated Steatotic Liver Disease Refractory to Standard Dose |
| title_full_unstemmed | Effectiveness of Pemafibrate Dose Escalation on Metabolic Dysfunction-Associated Steatotic Liver Disease Refractory to Standard Dose |
| title_short | Effectiveness of Pemafibrate Dose Escalation on Metabolic Dysfunction-Associated Steatotic Liver Disease Refractory to Standard Dose |
| title_sort | effectiveness of pemafibrate dose escalation on metabolic dysfunction associated steatotic liver disease refractory to standard dose |
| topic | non-alcoholic fatty liver disease non-alcoholic steatohepatitis pemafibrate dyslipidemia metabolic dysfunction-associated steatotic liver disease |
| url | https://www.mdpi.com/2218-1989/15/2/100 |
| work_keys_str_mv | AT satoshishinozaki effectivenessofpemafibratedoseescalationonmetabolicdysfunctionassociatedsteatoticliverdiseaserefractorytostandarddose AT kouichimiura effectivenessofpemafibratedoseescalationonmetabolicdysfunctionassociatedsteatoticliverdiseaserefractorytostandarddose AT toshiyukitahara effectivenessofpemafibratedoseescalationonmetabolicdysfunctionassociatedsteatoticliverdiseaserefractorytostandarddose AT hironoriyamamoto effectivenessofpemafibratedoseescalationonmetabolicdysfunctionassociatedsteatoticliverdiseaserefractorytostandarddose |