Evidence mapPaperPMID 26328624Full record

Trial reportLipids in health and disease2015

Effects of omega-3 carboxylic acids on lipoprotein particles and other cardiovascular risk markers in high-risk statin-treated patients with residual hypertriglyceridemia: a randomized, controlled, double-blind trial.

Richard L Dunbar, Stephen J Nicholls, Kevin C Maki, Eli M Roth, David G Orloff, Danielle Curcio, Judith Johnson, Douglas Kling, Michael H Davidson

Registry-linked trialOpen access · goldFull text readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Lipids in health and disease, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01408303 (A 6-Week, Randomized, Double-Blind, Placebo), which is not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
4.4field-weighted citation impact, top 5% 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.

NCT01408303 phase3completednot on this map

A 6-Week, Randomized, Double-Blind, Placebo(Olive Oil)-Controlled Study to Assess the Efficacy and Safety of Add-On Epanova® to Statin Therapy in Subjects With Persistent Hypertriglyceridemia and High Risk for Cardiovascular Disease

TypeinterventionalSponsorAstraZenecaRan2011 to 2012Enrolled646ConditionsHypertriglyceridemia, Cardiovascular DiseaseArmsOlive oil, 4g, omega-3-carboxylic acids, 2g, omega-3-carboxylic acids, 4g
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 53 citations in OpenAlex.

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  10. Metabolism of Triglyceride-Rich Lipoproteins.Handbook of experimental pharmacology · 2022
    Article
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Mechanistic insights into cardiovascular protection for omega-3 fatty acids and their bioactive lipid metabolites.European heart journal supplements : journal of the European Society of Cardiology · 2020
    Article
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  18. Review
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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 at 8 institutions in 2 countries.

Richard L DunbarDivision of Translational Medicine & Human Genetics, Perelman School of Medicine at the University of Pennsylvania, 3600 Spruce Street, 8046 Maloney Building, Philadelphia, PA, 19104-2699, USA. richard.dunbar@uphs.upenn.edu.
Stephen J NichollsSouth Australian Health & Medical Research Institute, University of Adelaide, Adelaide, Australia. stephen.nicholls@sahmri.com.
Kevin C MakiMidwest Center for Metabolic & Cardiovascular Research, Chicago, IL, USA. kmaki@mc-mcr.com.
Eli M RothSterling Research Group, Cincinnati, OH, USA. eroth@sterlingresearch.org.
David G OrloffMedpace, Inc., Cincinnati, OH, USA. d.orloff@medpace.com.
Danielle CurcioOmthera Pharmaceuticals, Princeton, NJ, USA. dcurcio319@gmail.com.
Judith JohnsonOmthera Pharmaceuticals, Princeton, NJ, USA. judithbjohnson@gmail.com.
Douglas KlingOmthera Pharmaceuticals, Princeton, NJ, USA. douglaskling@gmail.com.
Michael H DavidsonOmthera Pharmaceuticals, Princeton, NJ, USA. mdavidson@omthera.com.
Princeton University · USAstraZeneca (United States) · USIdera Pharmaceuticals (United States) · USMB Clinical Research and Consulting (United States) · USMedpace (United States) · USSterling Research Group · USUniversity of Adelaide · AUUniversity of Pennsylvania · US

Funding

NHLBI NIH HHS K23 HL091130NHLBI NIH HHS K23HL091130
6 · The paper itself

Abstract

backgroundThis study examined the effects of a mixture of highly bioavailable omega-3 carboxylic acids (OM3-CA) on nuclear magnetic resonance spectroscopy-assessed lipoprotein particle concentrations and sizes and other cardiovascular risk markers in statin-treated patients with fasting triglycerides (TG) ≥ 2.3 mmol/L (200 mg/dL) and <5.6 mmol/L (500 mg/dL) and at high cardiovascular risk.

methodsAfter a diet lead-in and statin-stabilization period, 647 patients were randomly assigned to receive capsules of control (olive oil, OO) 4 g/d, OM3-CA 2 g/d (plus OO 2 g/d), or OM3-CA 4 g/d for 6 weeks.

resultsCompared with OO, low-density lipoprotein (LDL) particle size was increased with OM3-CA 2 g/d (p < 0.01) and 4 g/d (p < 0.001), and very low-density lipoprotein (VLDL) and high-density lipoprotein (HDL) particle sizes were decreased with both OM3-CA dosages vs. OO (p < 0.001 and p < 0.05 for VLDL and HDL, respectively). Total VLDL/chylomicron remnant particle concentration was reduced by 8.5 and 16.0 % with OM3-CA 2 and 4 g/d, respectively, vs. a 6.9 % reduction with OO (p < 0.001 for OM3-CA 4 g/d vs. OO). Total HDL particle concentration was also reduced by 1.5 and 3.2 % with OM3-CA 2 and 4 g/d, respectively, vs. a 0.6 % increase with OO (at least p < 0.05 for both comparisons). Changes in total LDL particle concentration were not significantly different for OO vs. OM3-CA at either dosage. Apolipoprotein (Apo) CIII levels decreased by 7.6 and 13.1 % with OM3-CA 2 and 4 g/d, respectively, vs. 3.2 % with OO (p < 0.001 for OM3-CA 4 g/d vs. OO). Lipoprotein-associated phospholipase A2 (Lp-PLA2) mass was reduced by 6.2 and 10.7 % with OM3-CA 2 and 4 g/d, respectively, vs. a 0.1 % increase with OO (p < 0.001 for both vs. OO). There were no significant differences between treatments in high-sensitivity C-reactive protein responses.

conclusionOM3-CA were associated with shifts in lipoprotein particle sizes and concentrations, and reductions in Apo CIII and Lp-PLA2, in patients with hypertriglyceridemia while taking a statin.

trial registrationClinicalTrials.gov Identifier NCT01408303.

Indexed as

AgedAnticholesteremic AgentsApolipoprotein C-IIICardiovascular DiseasesCholesterol, LDLCholesterol, VLDLChylomicron RemnantsC-Reactive ProteinDocosahexaenoic AcidsDouble-Blind MethodEicosapentaenoic AcidFemaleHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypertriglyceridemiaLipoproteins, HDLAnticholesteremic AgentsApolipoprotein C-IIICholesterol, LDLCholesterol, VLDLChylomicron RemnantsC-Reactive ProteinDocosahexaenoic AcidsEicosapentaenoic AcidHydroxymethylglutaryl-CoA Reductase InhibitorsLipoproteins, HDLOlive OilPhospholipases A2Triglycerides

Identifiers

PMID26328624
PMCPMC4557761
OpenAlexW2136794447

What Socratic holds

Textfull text, public
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 Socratic graph.