Evidence mapPaperPMID 40436796Full record

Trial reportJournal of atherosclerosis and thrombosis2025

Effects of Pemafibrate on Cholesterol Synthesis and Absorption: a Post-Hoc Subgroup Analysis of a Phase 2 Clinical Trial.

Shizuya Yamashita, Eiichi Araki, Hidenori Arai, Koutaro Yokote, Ryohei Tanigawa, Ayumi Saito, Hideki Suganami, Sara Minamikawa, Shun Ishibashi

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of atherosclerosis and thrombosis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Does Pemafibrate Lower Low-Density Lipoprotein-Cholesterol?Journal of atherosclerosis and thrombosis · 2025
    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.

Shizuya YamashitaRinku General Medical Center.
Eiichi ArakiKikuchi Medical Association Hospital.
Hidenori AraiNational Center for Geriatrics and Gerontology.
Koutaro YokoteChiba University.
Ryohei TanigawaGlobal Clinical Development Department, Kowa Company Ltd.
Ayumi SaitoGlobal Clinical Development Department, Kowa Company Ltd.
Hideki SuganamiClinical Data Science Department, Kowa Company Ltd.
Sara MinamikawaMedical Affairs Department, Kowa Company Ltd.
Shun IshibashiDivision of Endocrinology and Metabolism, Department of Internal Medicine, School of Medicine, Jichi Medical University.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimRecently, we reported that a pemafibrate extended-release (XR) formulation lowered low-density lipoprotein cholesterol (LDL-C) and cholesterol synthesis and absorption markers in a phase 2 clinical pharmacology study. Here we describe our post-hoc analysis of that study, discuss the mechanism by which pemafibrate lowers LDL-C, and suggest which patients may respond favorably to pemafibrate treatment.

methodsIn the phase 2 study, patients with hypertriglyceridemia received treatment with pemafibrate immediate-release (IR) 0.2 mg/day or XR 0.4 mg/day or 0.8 mg/day. This post-hoc subgroup analysis examined the percentage change in LDL-C, apolipoprotein B (ApoB), non-HDL-C, and cholesterol synthesis and absorption markers, in subgroups by baseline LDL-C, and then determined the correlation between the percentage change in LDL-C and the percentage change in cholesterol synthesis and absorption markers.

resultsOur analysis included 60 patients who received two of three formulations of the drug. A total of 78.3% (47/60) were male, 16.7% (10/60) had type 2 diabetes mellitus, and 10% (6/60) received concomitant statins. The percentage of LDL-C lowering was greater in the population with high baseline LDL-C, and similar trends were noted for the ApoB, non-HDL-C, and cholesterol synthesis and absorption markers. The percentage change in LDL-C was positively correlated with the percentage change in lathosterol, β-sitosterol, and campesterol.

conclusionsIn patients with hypertriglyceridemia, results suggested that pemafibrate lowered LDL-C by inhibiting cholesterol synthesis in the liver and cholesterol absorption from the intestinal tract. This lowering effect was greater in populations with higher baseline LDL-C.

Indexed as

BenzoxazolesButyratesCholesterolHypertriglyceridemiaAgedBiomarkersCholesterol, LDLFemaleHumansIntestinal AbsorptionMaleMiddle AgedBenzoxazolesBiomarkersButyratesCholesterolCholesterol, LDL(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acidCampesterolLathosterolLDL-CPemafibrateβ-sitosterol

Identifiers

PMID40436796
PMCPMC12597483

What Socratic holds

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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 Socratic graph.