Evidence map›Paper›PMID 32200533›Full record

Trial reportAdvances in therapy2020

Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of the Effect of Omega-3 Fatty Acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia.

Tamio Teramoto, Hirotaka Shibata, Yuki Suzaki, Shingo Matsui, Naoto Uemura, Hirofumi Tomiyama, Akira Yamashina

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02824432 (Exploratory Study of the Effect of Omega-3-acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 49% 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.

NCT02824432 phase4completednot on this map

Exploratory Study of the Effect of Omega-3-acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation

TypeinterventionalSponsorTakedaRan2016 to 2017Enrolled37ConditionsHyperlipidemiaArmsTAK-085
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  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

7 authors at 4 institutions in 1 country.

Tamio TeramotoTeikyo Academic Research Center, Teikyo University, Tokyo, Japan.
Hirotaka ShibataFaculty of Medicine, Oita University, Oita, Japan.
Yuki SuzakiTakeda Pharmaceutical Company Limited, Tokyo, Japan. yuki.suzaki@takeda.com.
Shingo MatsuiTakeda Pharmaceutical Company Limited, Tokyo, Japan.
Naoto UemuraFaculty of Medicine, Oita University, Oita, Japan.
Hirofumi TomiyamaDepartment of Cardiology, Tokyo Medical University, Tokyo, Japan.
Akira YamashinaDepartment of Cardiology, Tokyo Medical University, Tokyo, Japan.
Oita University · JPTakeda (Japan) · JPTokyo Medical University · JPTeikyo University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOmega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation (Lotriga

methodsPatients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors were randomized 1:1 to receive omega-3 at 2 g (QD) or 4 g (2 g BID) for 8 weeks. The primary end point was the change from baseline of fasting  %FMD in each treatment group. Secondary end points included the 4-h postprandial  %FMD and 4-h postprandial triglyceride (TG) level.

resultsThirty-seven patients were randomized to receive omega-3 at 2 g (n = 18) or 4 g (n = 19). Mean fasting %FMD did not increase from baseline to week 8 in the 2-g group (- 1.2%) or 4-g group (- 1.3%). Mean 4-h postprandial %FMD did not change from baseline to week 8 in the 2-g group (0.0%), but increased in the 4-g group (1.0%). Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001). No new safety concerns were identified.

conclusionsFasting %FMD did not improve after 8 weeks of omega-3 treatment at 2 g or 4 g. After 8 weeks, 4-h postprandial TG levels showed improvement at both doses, with a greater reduction in the 4-g group.

trial registrationClinicalTrials.gov, ID: NCT02824432.

Indexed as

AdultAgedAged, 80 and overEndothelium, VascularFastingFatty Acids, Omega-3FemaleHumansHyperlipidemiasJapanMaleMiddle AgedPostprandial PeriodRandom AllocationFatty Acids, Omega-3DyslipidemiaFlow-mediated dilationHyperlipidemiaLotriga®Omega-3 fatty acid ethyl estersTriglyceridemiaVascular endothelial function

Identifiers

PMID32200533
PMCPMC7467499
OpenAlexW3011931948

What OpenQuestion holds

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LicenceCC BY
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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 OpenQuestion graph.