Randomized controlled trial2016Industry funded

Funded in part by Amarin Pharma

Icosapent ethyl (eicosapentaenoic acid ethyl ester): Effects on remnant-like particle cholesterol from the MARINE and ANCHOR studies

Ballantyne CM, Bays HE, Philip S, Doyle RT, Braeckman RA, Stirtan WG, Soni PN, Juliano RA

Atherosclerosis · 39 citations

Review labels

Industry funded

Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.

How it was studied

Design
Randomized controlled trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Industry funded
Government
U.S. Food and Drug Administration
Company
Amarin Pharma

Based on 2 listed funder(s).

Publication

Published
2016-08-23 · Atherosclerosis · vol. 253 · pp. 81–87
Publisher
Elsevier BV
Cited
52 citations · more than 94% of similar papers · 4.4× the field average
Impact
Top 10% most cited in its field
References
44 works
Access
Open access (hybrid journal) · CC-BY-NC-ND
Research areas
Fatty Acid Research and Health · Antioxidant Activity and Oxidative Stress · Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
Eicosapentaenoic acid, Triglyceride, Placebo, Internal medicine, Statin, Ethyl ester, Medicine, Cholesterol, Endocrinology, Fatty acid, Chemistry, Biochemistry, Polyunsaturated fatty acid, Pathology
MeSH
humans, cardiovascular diseases, hypertriglyceridemia, cholesterol, fatty acids, omega-3, eicosapentaenoic acid, triglycerides, lipoproteins, platelet aggregation inhibitors, hydroxymethylglutaryl-coa reductase inhibitors, data interpretation, statistical, double-blind method, adult, aged, middle aged, female, male, atherosclerosis, hypolipidemic agents

8 authors

From US

  • Christie Mitchell Ballantyne · correspondingHouston Methodist; Baylor College of Medicine
  • Harold Edward BaysLouisville Metabolic and Atherosclerosis Research Center
  • Sephy PhilipAmarin (United States)
  • Ralph T. DoyleAmarin (United States)
  • Rene A. BraeckmanAmarin (United States)
  • William G. StirtanAmarin (United States)

Abstract

Background and aims

Remnant-like particle cholesterol (RLP-C) is atherogenic and may increase atherosclerotic cardiovascular disease risk. Icosapent ethyl is a high-purity prescription eicosapentaenoic acid ethyl ester (approved as an adjunct to diet to reduce triglyceride [TG] levels in adult patients with TGs ≥500 mg/dL [≥5.65 mmol/L] at 4 g/day). In the MARINE and ANCHOR studies, icosapent ethyl reduced TG and other atherogenic lipid parameter levels without increasing low-density lipoprotein cholesterol (LDL-C) levels. This exploratory analysis evaluated the effects of icosapent ethyl on calculated and directly measured RLP-C.

Methods

MARINE (TGs ≥500 and ≤2000 mg/dL [≥5.65 mmol/L and ≤22.6 mmol/L]) and ANCHOR (TGs ≥200 and <500 mg/dL [≥2.26 and <5.65 mmol/L] despite statin-controlled LDL-C) were phase 3, 12-week, double-blind studies that randomized adult patients to icosapent ethyl 4 g/day, 2 g/day, or placebo. This analysis assessed median percent change from baseline to study end in directly measured (immunoseparation assay) RLP-C levels (MARINE, n = 218; ANCHOR, n = 252) and calculated RLP-C levels in the full populations.

Results

Icosapent ethyl 4 g/day significantly reduced directly measured RLP-C levels -29.8% (p = 0.004) in MARINE and -25.8% (p = 0.0001) in ANCHOR versus placebo, and also reduced directly measured RLP-C levels to a greater extent in subgroups with higher versus lower baseline TG levels, in patients receiving statins versus no statins (MARINE), and in patients receiving medium/higher-intensity versus lower-intensity statins (ANCHOR). Strong correlations were found between calculated and directly measured RLP-C for baseline, end-of-treatment, and percent change values in ANCHOR and MARINE (0.73-0.92; p < 0.0001 for all).

Conclusions

Icosapent ethyl 4 g/day significantly reduced calculated and directly measured RLP-C levels versus placebo in patients with elevated TG levels from the MARINE and ANCHOR studies.

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).

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