Evidence map›Paper›PMID 39924184›Full record

Trial reportJournal of atherosclerosis and thrombosis2025

Long-Term Effects of Extended-Release Pemafibrate Tablets on Dyslipidemia and Safety in Triglyceridemic Patients: A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study.

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

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
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. It is linked to trial NCT04716595 (A Phase III Long Term Study of K-877 Extended Release Tablet-A Multicenter, Randomized, Open Label, Parallel Group Trial in Patients With Dyslipidemia With High TG-), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04716595 phase3completednot on this map

A Phase III Long Term Study of K-877 Extended Release Tablet-A Multicenter, Randomized, Open Label, Parallel Group Trial in Patients With Dyslipidemia With High TG-

TypeinterventionalSponsorKowa Company, Ltd.Ran2021 to 2022Enrolled121ConditionsDyslipidemiasArmsK-877 ER 0.2 mg/day morning administration (once daily), K-877 ER 0.2 mg/day evening administration (once daily)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
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.

Hidenori AraiNational Center for Geriatrics and Gerontology.
Shizuya YamashitaDepartment of Cardiology, Rinku General Medical Center.
Eiichi ArakiKikuchi Medical Association Hospital.
Koutaro YokoteChiba University.
Ryohei TanigawaGlobal Clinical Development Department, Kowa Company, Ltd.
Ayumi SaitoGlobal Clinical Development Department, Kowa Company, Ltd.
Daisuke FurukawaMedical Affairs Department, Kowa Company, Ltd.
Hideki SuganamiClinical Data Science 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

aimsLong-term safety and efficacy of pemafibrate once-daily extended-release (XR) tablets, taken in morning or evening, were evaluated in dyslipidemic patients with high triglycerides (TG).

methodsIn this multicenter, randomized, open-label, parallel-group, phase 3 long-term study, dyslipidemic patients with high TG were randomly assigned to morning or evening administration of XR for 52 weeks. The dose was started at 0.2 mg/day and increased to 0.4 mg/day for patients having fasting serum TG ≥ 150mg/dL during treatment. The primary efficacy endpoint was percent change in fasting serum TG.

resultsThe study enrolled 121 patients, assigning 61 to morning and 60 to evening administration. The study population included 71.1% males. Mean age was 58.5±11.1 (mean±SD) years, body mass index 27.7±4.3 kg/m

conclusionsLong-term, once-daily administration of XR was effective and safe in dyslipidemic patients with high TG. XR provided favorable TG-lowering effects regardless of morning or evening administration, and the XR dose increase proved effective in patients having initially inadequate response.

Indexed as

BenzoxazolesButyratesDyslipidemiasHypolipidemic AgentsTriglyceridesAgedDelayed-Action PreparationsFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisTabletsBenzoxazolesButyratesDelayed-Action PreparationsHypolipidemic Agents(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acidTabletsTriglyceridesExtended releaseLong-term effectPemafibrateSelective PPARα modulatorTriglycerides

Identifiers

PMID39924184
PMCPMC12328711

What Socratic holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

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.