Evidence map›Paper›PMID 29628483›Full record

Trial reportJournal of atherosclerosis and thrombosis2018

Efficacy and Safety of Pemafibrate Versus Fenofibrate in Patients with High Triglyceride and Low HDL Cholesterol Levels: A Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial.

Hidenori Arai, Shizuya Yamashita, Koutaro Yokote, Eiichi Araki, Hideki Suganami, Shun Ishibashi, K-877 Study Group

Open access · diamondAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of atherosclerosis and thrombosis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 94 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 3 pooled it
9.8field-weighted citation impact, top 1% of its field
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

94 citing papers in PubMed, 3 syntheses or guidelines pooled it, 133 citations in OpenAlex.

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34 more citing papers are in PubMed but not listed here.

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

7 authors at 5 institutions in 1 country.

Hidenori AraiNational Center for Geriatrics and Gerontology.
Shizuya YamashitaDepartment of Community Medicine and Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine.
Koutaro YokoteDepartment of Diabetes, Metabolism and Endocrinology, Chiba University Graduate School of Medicine.
Eiichi ArakiDepartment of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University.
Hideki SuganamiClinical Data Science Department, Kowa Company, Ltd.
Shun IshibashiDivision of Endocrinology and Metabolism, Department of Medicine, Jichi Medical University.
K-877 Study Group
Chiba University · JPJichi Medical University Hospital · JPKumamoto University · JPNational Center for Geriatrics and Gerontology · JPOsaka University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo verify the superiority of pemafibrate over placebo and the non-inferiority of pemafibrate to the maximum dose of fenofibrate for determining the percent change in fasting serum triglyceride (TG) levels and to investigate safety by assessing the incidence of adverse events (AEs) and adverse drug reactions (ADRs).

methodsThis phase III, placebo/active drug-controlled, randomized, double-blind, parallel group comparison study enrolled patients with high TG and low high-density lipoprotein cholesterol levels. Patients were randomly assigned to receive placebo; pemafibrate 0.1 mg/day, 0.2 mg/day, or 0.4 mg/day; or fenofibrate 100 mg/day or 200 mg/day for 12 weeks.

resultsAmong 526 randomized patients, 489 completed the study, with drop-out rates of 0%, 6.7%, 5.5%, 5.9%, 8.2%, and 10.7% in the placebo; pemafibrate 0.1 mg/day, 0.2 mg/day, and 0.4 mg/day; and fenofibrate 100 mg/day and 200 mg/day groups. The study showed the non-inferiority of pemafibrate 0.4 mg/day and 0.2 mg/day to fenofibrate 200 mg/day as well the non-inferiority and superiority of all pemafibrate doses to fenofibrate 100 mg/day for reducing TG levels. No dose-dependent increase in the incidence of AEs or ADRs was observed among the pemafibrate dose groups. The incidence of AEs and ADRs for all pemafibrate doses was similar to that for placebo and fenofibrate 100 mg/day and significantly lower than that for fenofibrate 200 mg/day (P＜0.05).

conclusionsThe favorable safety profile of pemafibrate, with fewer adverse effects on kidney/liver-related laboratory tests and fewer AEs/ADRs, including those leading to treatment discontinuation, over fenofibrate 200 mg/day may justify the use of this novel and potent treatment option for reducing TG levels in a broader range of patients.

Indexed as

BenzoxazolesBiomarkersButyratesCholesterol, HDLDouble-Blind MethodFemaleFenofibrateFollow-Up StudiesHumansHypertriglyceridemiaHypolipidemic AgentsMaleMiddle AgedPrognosisTriglyceridesBenzoxazolesBiomarkersButyratesCholesterol, HDLFenofibrateHypolipidemic Agents(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acidTriglyceridesFibrateResidual riskSafetySelective PPARα modulatorTriglycerides

Identifiers

PMID29628483
PMCPMC6005227
OpenAlexW2796005123

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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Registered trials

None linked

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.