Evidence map›Paper›PMID 30788718›Full record

ArticleCardiology and therapy2019

Icosapent Ethyl Effects on Fatty Acid Profiles in Statin-Treated Patients With High Triglycerides: The Randomized, Placebo-controlled ANCHOR Study.

Christie M Ballantyne, Mehar S Manku, Harold E Bays, Sephy Philip, Craig Granowitz, Ralph T Doyle, Rebecca A Juliano

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cardiology and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01047501 (Evaluation of the Effect of Two Doses of AMR101), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 20% 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
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. 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
  9. Dietary and Pharmacological Fatty Acids and Cardiovascular Health.The Journal of clinical endocrinology and metabolism · 2020
    Review
  10. Article
  11. Review
  12. 2022 Saudi Guidelines for the Management of Dyslipidemia.Heart views : the official journal of the Gulf Heart Association
    Article
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 3 institutions in 1 country.

Christie M BallantyneDepartment of Medicine, Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA. cmb@bcm.tmc.edu.
Mehar S MankuAmarin Pharma Inc, Bedminster, NJ, USA.
Harold E BaysClinical Research, Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA.
Sephy PhilipMedical Affairs, Amarin Pharma Inc, Bedminster, NJ, USA.
Craig GranowitzMedical Affairs, Amarin Pharma Inc, Bedminster, NJ, USA.
Ralph T DoyleResearch and Development, Amarin Pharma Inc, Bedminster, NJ, USA.
Rebecca A JulianoResearch and Development, Amarin Pharma Inc, Bedminster, NJ, USA.
Amarin (United States) · USHouston Methodist · USLouisville Metabolic and Atherosclerosis Research Center · US

Funding

Amarin Pharma Inc. n/a
6 · The paper itself

Abstract

introductionFatty acid content in plasma and red blood cells (RBCs) may provide insight into potential physiologic benefits of omega-3 fatty acids. Icosapent ethyl is a pure prescription form of eicosapentaenoic acid (EPA) ethyl ester approved by the US Food and Drug Administration at a dose of 4 g/day as an adjunct to diet to reduce triglyceride levels in adults with severe (≥ 500 mg/dl) hypertriglyceridemia.

methodsThis was a prespecified exploratory subset analysis of the ANCHOR study, which randomized 702 statin-treated patients at increased cardiovascular risk with triglycerides 200-499 mg/dl and controlled low-density lipoprotein cholesterol (40-99 mg/dl). This analysis examined effects of icosapent ethyl 4 g/day versus placebo on fatty acid levels in plasma and RBCs using a gas chromatograph assay method with flame ionization detector.

resultsIn plasma, treatment with icosapent ethyl 4 g/day resulted in significant increases versus placebo in the mean concentrations of EPA (+ 635%; P < 0.0001) and its metabolite, docosapentaenoic acid n-3 (+ 143%; P < 0.0001) with no significant change in docosahexaenoic acid. Treatment with icosapent ethyl 4 g/day versus placebo also resulted in significant decreases in the omega-6 fatty acids linoleic acid (- 25%) and arachidonic acid (AA; - 31%), as well as the AA/EPA ratio (- 91%). Icosapent ethyl 4 g/day also decreased the omega-9 fatty acid oleic acid (- 29%) and the saturated fatty acids palmitic acid (- 23%) and stearic acid (- 16%) (all P < 0.0001). Results were similar for RBCs.

conclusionsIcosapent ethyl 4 g/day significantly increased EPA and produced other potentially beneficial shifts in fatty acids in plasma and RBCs versus placebo.

trial registrationClinicalTrials.gov Identifier, NCT01047501

fundingAmarin Pharma Inc. Plain language summary available for this article.

Indexed as

Arachidonic acidEicosapentaenoic acidFatty acidsHypertriglyceridemiaIcosapent ethylOmega-3 fatty acidsOmega-6 fatty acids

Identifiers

PMID30788718
PMCPMC6525216
OpenAlexW2916623077

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.