Evidence map›Paper›PMID 38777770›Full record

Trial reportJournal of atherosclerosis and thrombosis2024

Comparison of Efficacy between Pemafibrate and Omega-3-Acid Ethyl Ester in the Liver: the PORTRAIT Study.

Yoshio Sumida, Hidenori Toyoda, Satoshi Yasuda, Satoshi Kimoto, Kazumasa Sakamoto, Yukiomi Nakade, Kiyoaki Ito, Takeshi Osonoi, Masashi Yoneda

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Journal of atherosclerosis and thrombosis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Does Pemafibrate Lower Low-Density Lipoprotein-Cholesterol?Journal of atherosclerosis and thrombosis · 2025
    Article
  8. Effect of Pemafibrate on Metabolic Dysfunction-Associated Steatotic Liver Disease: A Nationwide Multicenter Study.JGH open : an open access journal of gastroenterology and hepatology · 2025
    Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Yoshio SumidaDivision of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University.
Hidenori ToyodaDepartment of Gastroenterology, Ogaki Municipal Hospital.
Satoshi YasudaDepartment of Gastroenterology, Ogaki Municipal Hospital.
Satoshi KimotoDivision of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University.
Kazumasa SakamotoDivision of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University.
Yukiomi NakadeDivision of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University.
Kiyoaki ItoDivision of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University.
Takeshi OsonoiNakakinen Clinic.
Masashi YonedaDivision of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimNo pharmacotherapeutic treatment has been established for metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). This trial compared the effects of pemafibrate and omega-3-acid ethyl ester on hepatic function in patients with hypertriglyceridemia complicated by MASLD.

methodsPatients with hypertriglyceridemia complicated by MASLD were enrolled, randomly assigned to the pemafibrate or omega-3-acid ethyl ester group, and followed for 24 weeks. The primary endpoint was the change in alanine aminotransferase (ALT) from baseline to week 24. The secondary endpoints included other hepatic enzymes, lipid profiles, and hepatic fibrosis biomarkers.

resultsA total of 80 patients were enrolled and randomized. The adjusted mean change in ALT from baseline to week 24 was significantly lower in the pemafibrate group (-19.7±5.9 U/L) than in the omega-3-acid ethyl ester group (6.8±5.5 U/L) (intergroup difference, -26.5 U/L; 95% confidence interval, -42.3 to -10.7 U/L; p=0.001). Pemafibrate significantly improved the levels of other hepatic enzymes (aspartate aminotransferase and gamma-glutamyl transpeptidase), lipid profiles (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol), and hepatic fibrosis biomarkers (Mac-2 binding protein glycan isomer and Fibrosis-4 index). No cases of discontinuation due to adverse drug reactions were identified in either group, and there were no safety concerns.

conclusionsPemafibrate is recommended over omega-3-acid ethyl ester for lipid management and MASLD treatment in patients with hypertriglyceridemia complicated by MASLD. The study results may contribute to the development of future treatment strategies for patients with MASLD/MASH.

Indexed as

BenzoxazolesButyratesFatty Acids, Omega-3HypertriglyceridemiaAdultAgedAlanine TransaminaseBiomarkersFatty LiverFemaleFollow-Up StudiesHumansLiverMaleMiddle AgedTreatment OutcomeAlanine TransaminaseBenzoxazolesBiomarkersButyratesFatty Acids, Omega-3(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acidHepatic fibrosisHepatic functionMetabolic dysfunction-associated steatotic liver diseaseOmega-3-acid ethyl esterPemafibrate

Identifiers

PMID38777770
PMCPMC11537790

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.