Impact of pemafibrate in patients with metabolic dysfunction-associated steatotic liver disease complicated by dyslipidemia : A single-arm prospective study
(2024) In JGH Open 8(4).- Abstract
BACKGROUND AND AIM: This study aimed to clarify the efficacy and safety of 48-week pemafibrate treatment in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) complicated by dyslipidemia.
METHODS: A total of 110 patients diagnosed with MASLD complicated by dyslipidemia received pemafibrate at a dose of 0.1 mg twice daily for 48 weeks.
RESULTS: The participants were 54 males and 37 females, with a median age of 63 (52-71) years. Besides improvement in lipid profile, significant reductions from baseline to 48 weeks of treatment were found in liver-related enzymes, such as aspartate aminotransferase, alanine aminotransferase (ALT), gamma-glutamyl transpeptidase, and alkaline phosphatase (
P ... (More)BACKGROUND AND AIM: This study aimed to clarify the efficacy and safety of 48-week pemafibrate treatment in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) complicated by dyslipidemia.
METHODS: A total of 110 patients diagnosed with MASLD complicated by dyslipidemia received pemafibrate at a dose of 0.1 mg twice daily for 48 weeks.
RESULTS: The participants were 54 males and 37 females, with a median age of 63 (52-71) years. Besides improvement in lipid profile, significant reductions from baseline to 48 weeks of treatment were found in liver-related enzymes, such as aspartate aminotransferase, alanine aminotransferase (ALT), gamma-glutamyl transpeptidase, and alkaline phosphatase (
P < 0.001 for all). A significant decrease in the homeostasis model assessment-insulin resistance (HOMA-IR) was observed in patients with insulin resistance (HOMA-IR ≥ 2.5) (4.34 at baseline to 3.89 at Week 48,
P < 0.05). Moreover, changes in ALT were weakly correlated with those in HOMA-IR (
r = 0.34;
p < 0.05). Regarding noninvasive liver fibrosis tests, platelets, Wisteria floribunda agglutinin-positive Mac-2-binding protein, type IV collagen 7s, and the non-alcoholic fatty liver disease fibrosis score significantly decreased from baseline to Week 48. Most adverse events were Grades 1-2, and no drug-related Grade 3 or higher adverse events were observed.
CONCLUSION: This study demonstrated that 48-week pemafibrate administration improved liver-related enzymes and surrogate marker of liver fibrosis in patients with MASLD. The improvement of insulin resistance by pemafibrate may contribute to the favorable effect on MASLD complicated by dyslipidemia.
(Less)
- author
- publishing date
- 2024-04
- type
- Contribution to journal
- publication status
- published
- subject
- in
- JGH Open
- volume
- 8
- issue
- 4
- article number
- e13057
- publisher
- John Wiley & Sons Inc.
- external identifiers
-
- pmid:38572327
- scopus:85189163624
- ISSN
- 2397-9070
- DOI
- 10.1002/jgh3.13057
- language
- English
- LU publication?
- no
- additional info
- © 2024 The Authors. JGH Open published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.
- id
- 56f17f84-7c4a-48e1-9067-034aee2f3702
- date added to LUP
- 2025-01-12 02:02:48
- date last changed
- 2025-07-13 19:01:35
@article{56f17f84-7c4a-48e1-9067-034aee2f3702,
abstract = {{<p>BACKGROUND AND AIM: This study aimed to clarify the efficacy and safety of 48-week pemafibrate treatment in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) complicated by dyslipidemia.</p><p>METHODS: A total of 110 patients diagnosed with MASLD complicated by dyslipidemia received pemafibrate at a dose of 0.1 mg twice daily for 48 weeks.</p><p>RESULTS: The participants were 54 males and 37 females, with a median age of 63 (52-71) years. Besides improvement in lipid profile, significant reductions from baseline to 48 weeks of treatment were found in liver-related enzymes, such as aspartate aminotransferase, alanine aminotransferase (ALT), gamma-glutamyl transpeptidase, and alkaline phosphatase (<br>
P < 0.001 for all). A significant decrease in the homeostasis model assessment-insulin resistance (HOMA-IR) was observed in patients with insulin resistance (HOMA-IR ≥ 2.5) (4.34 at baseline to 3.89 at Week 48, <br>
P < 0.05). Moreover, changes in ALT were weakly correlated with those in HOMA-IR ( <br>
r = 0.34; <br>
p < 0.05). Regarding noninvasive liver fibrosis tests, platelets, Wisteria floribunda agglutinin-positive Mac-2-binding protein, type IV collagen 7s, and the non-alcoholic fatty liver disease fibrosis score significantly decreased from baseline to Week 48. Most adverse events were Grades 1-2, and no drug-related Grade 3 or higher adverse events were observed.<br>
</p><p>CONCLUSION: This study demonstrated that 48-week pemafibrate administration improved liver-related enzymes and surrogate marker of liver fibrosis in patients with MASLD. The improvement of insulin resistance by pemafibrate may contribute to the favorable effect on MASLD complicated by dyslipidemia.</p>}},
author = {{Ono, Hiroki and Atsukawa, Masanori and Tsubota, Akihito and Arai, Taeang and Suzuki, Kenta and Higashi, Tetsuyuki and Kitamura, Michika and Shioda-Koyano, Kaori and Kawano, Tadamichi and Yoshida, Yuji and Okubo, Tomomi and Hayama, Korenobu and Itokawa, Norio and Kondo, Chisa and Nagao, Mototsugu and Iwabu, Masato and Iwakiri, Katsuhiko}},
issn = {{2397-9070}},
language = {{eng}},
number = {{4}},
publisher = {{John Wiley & Sons Inc.}},
series = {{JGH Open}},
title = {{Impact of pemafibrate in patients with metabolic dysfunction-associated steatotic liver disease complicated by dyslipidemia : A single-arm prospective study}},
url = {{http://dx.doi.org/10.1002/jgh3.13057}},
doi = {{10.1002/jgh3.13057}},
volume = {{8}},
year = {{2024}},
}