Evidence map›Paper›PMID 23325450›Full record

Trial reportAmerican journal of cardiovascular drugs : drugs, devices, and other interventions2013

Icosapent ethyl, a pure ethyl ester of eicosapentaenoic acid: effects on circulating markers of inflammation from the MARINE and ANCHOR studies.

Harold E Bays, Christie M Ballantyne, Rene A Braeckman, William G Stirtan, Paresh N Soni

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of cardiovascular drugs : drugs, devices, and other interventions, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 59 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 4 pooled it
6.7field-weighted citation impact, top 3% 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.

NCT01047501 phase3completednot on this map

Evaluation of the Effect of Two Doses of AMR101 (Ethyl Icosapentate) on Fasting Serum Triglyceride Levels in Patients With Persistent High Triglyceride Levels (≥ 200 mg/dL and < 500 mg/dL) Despite Statin Therapy

TypeinterventionalSponsorAmarin Pharma Inc.Ran2009 to 2011Enrolled702ConditionsHypertriglyceridemiaArmsAMR101 (ethyl icosapentate) - 4 g/day, AMR101 (ethyl icosapentate) - 2 g/day, Placebo
NCT01047683 phase3completednot on this map

Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL

TypeinterventionalSponsorAmarin Pharma Inc.Ran2009 to 2011Enrolled229ConditionsHypertriglyceridemiaArmsAMR101 (ethyl icosapentate) - 4 g/day, AMR101 (ethyl icosapentate) - 2 g/day, Placebo
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 4 syntheses or guidelines pooled it, 139 citations in OpenAlex.

  1. Pooled it
  2. Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Marine-derived n-3 fatty acids therapy for stroke.The Cochrane database of systematic reviews · 2019
    Pooled it
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  16. Do patients benefit from omega-3 fatty acids?Cardiovascular research · 2024
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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

5 authors at 3 institutions in 1 country.

Harold E BaysLouisville Metabolic and Atherosclerosis Research Center, 3288 Illinois Avenue, Louisville, KY 40213, USA. HBaysMD@aol.com
Christie M Ballantyne
Rene A Braeckman
William G Stirtan
Paresh N Soni
Amarin (United States) · USHouston Methodist · USLouisville Metabolic and Atherosclerosis Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIcosapent ethyl (IPE) is a high-purity prescription form of eicosapentaenoic acid ethyl ester approved by the US Food and Drug Administration as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. In addition to TG-lowering effects, IPE also reduces non-high-density lipoprotein cholesterol and apolipoprotein B levels without significantly increasing low-density lipoprotein cholesterol (LDL-C) in patients with very high TG levels ≥500 mg/dL (MARINE study) and in patients with well-controlled LDL-C and residually high TG levels 200-500 mg/dL (ANCHOR study). This analysis examined the effect of IPE on inflammatory markers in patients from MARINE and ANCHOR.

methodsMARINE (N = 229) and ANCHOR (N = 702) were Phase III, double-blind studies that randomized hypertriglyceridemic patients to IPE 4 g/day, 2 g/day, or placebo. This analysis assessed the median placebo-adjusted percentage change from baseline in markers representing various stages of atherosclerotic inflammation such as intercellular adhesion molecule-1 (ICAM-1), oxidized low-density lipoprotein (Ox-LDL), lipoprotein-associated phospholipase A(2) (Lp-PLA(2)), interleukin-6 (IL-6), and high-sensitivity C-reactive protein (hsCRP).

resultsCompared to placebo, IPE 4 g/day significantly decreased Ox-LDL (13 %, p < 0.0001, ANCHOR), Lp-PLA(2) (14 %, p < 0.001, MARINE; 19 %, p < 0.0001, ANCHOR), and hsCRP levels (36 %, p < 0.01, MARINE; 22 %, p < 0.001, ANCHOR), but did not significantly change ICAM-1 and IL-6 levels. In the MARINE study, IPE 2 g/day did not significantly change ICAM-1, Ox-LDL, Lp-PLA(2), IL-6, or hsCRP levels. Also, compared to placebo in the ANCHOR study, IPE 2 g/day significantly decreased Lp-PLA(2) levels (8 %, p < 0.0001), but did not significantly change levels of other assessed inflammatory markers.

conclusionCompared to placebo, in hypertriglyceridemic patients, IPE 4 g/day significantly decreased Ox-LDL, Lp-PLA(2), and hsCRP levels.

Indexed as

AdultAgedBiomarkersDouble-Blind MethodEicosapentaenoic AcidEstersFemaleFollow-Up StudiesHumansHypertriglyceridemiaInflammationInflammation MediatorsMaleMiddle AgedTreatment OutcomeBiomarkersEicosapentaenoic AcidEstersInflammation Mediators

Identifiers

PMID23325450
PMCPMC3572383
OpenAlexW2091743718

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.