Page last updated: 2024-12-05

eicosapentaenoic acid ethyl ester

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Eicosapentaenoic acid ethyl ester (EPA ethyl ester) is an ethyl ester derivative of eicosapentaenoic acid (EPA), an omega-3 fatty acid. It is a colorless to pale yellow liquid with a characteristic fishy odor. EPA ethyl ester is a highly unsaturated compound with five double bonds in its structure. It is commonly used as a dietary supplement and is also used in research studies to investigate the effects of EPA on various biological processes.

EPA ethyl ester is typically synthesized through esterification of EPA with ethanol. The esterification reaction can be catalyzed by acids, enzymes, or other catalysts.

EPA ethyl ester has been shown to have various effects on the body, including reducing inflammation, lowering blood pressure, and improving cardiovascular health. It is believed to exert these effects by modulating the production of inflammatory mediators, such as prostaglandins and leukotrienes.

EPA ethyl ester is studied extensively due to its potential health benefits. Researchers are investigating its effects on various diseases, including cardiovascular disease, inflammatory bowel disease, and cancer. It is also being explored as a potential therapeutic agent for conditions such as depression and Alzheimer's disease.

EPA ethyl ester is considered safe for consumption when taken at recommended doses. However, it is important to consult with a healthcare professional before taking any dietary supplements, including EPA ethyl ester, especially if you have any underlying medical conditions or are taking medications.'

Cross-References

ID SourceID
PubMed CID3298
MeSH IDM0108217
PubMed CID72187525
CHEMBL ID3183842
MeSH IDM0108217

Synonyms (11)

Synonym
eicosapentaenoic acid ethyl ester
86227-47-6
FT-0667829
ethyl icosa-5,8,11,14,17-pentaenoate
epa ethyl ester;ethyl eicosapentaenoate
dtxcid8031603
NCGC00249928-01
dtxsid7057814 ,
tox21_113704
cas-73310-10-8
CHEMBL3183842

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Our findings suggest that this toxic model is not reflective or predictive of findings in genetic mouse models, and may not be useful as a preclinical screen for HD therapeutics."( Cystamine and ethyl-eicosapentaenoic acid treatment fail to prevent malonate-induced striatal toxicity in mice.
Leavitt, BR; Sivananthan, SN, 2011
)
0.37
" However, prior medications with triglyceride-lowering effects have not reduced adverse clinical outcomes in the statin era."( Icosapent ethyl: safely reducing cardiovascular risk in adults with elevated triglycerides.
Bhatt, DL; Mason, RP; Pareek, M, 2022
)
0.72
" MND-2119 was safe and well tolerated."( Efficacy and safety of self-emulsifying formulation of highly purified eicosapentaenoic acid ethyl ester (MND-2119) versus highly purified eicosapentaenoic acid ethyl ester in patients with hypertriglyceridemia: Results from a 12-week randomized, double-b
Hayashi, K; Mori, T; Murasaki, K; Yokoyama, Y,
)
0.36
"The incidence of adverse events in MND-2119 2 g/day and MND-2119 4 g/day was 70."( Long-term safety and efficacy of MND-2119 (self-emulsifying formulation of highly purified eicosapentaenoic acid ethyl ester) in patients with hypertriglyceridemia: Results from a multicenter, 52-week, open-label study.
Mori, T; Murasaki, K; Yokoyama, Y,
)
0.35

Pharmacokinetics

ExcerptReferenceRelevance
" The objective of this study was to evaluate the effect of IPE on the pharmacokinetic and anticoagulation pharmacodynamics of warfarin, a substrate of cytochrome P450 2C9-mediated metabolism."( Phase 1 study of the effect of icosapent ethyl on warfarin pharmacokinetic and anticoagulation parameters.
Braeckman, RA; Soni, PN; Stirtan, WG, 2014
)
0.4
" Primary pharmacokinetic end points were area under the concentration-versus-time curve from zero to infinity (AUC(0-∞)) and maximum plasma concentration (C(max)) for R- and S-warfarin; pharmacodynamic end points were area under the international normalized ratio (INR) effect-time curve after the warfarin dose (AUC(INR)) and maximum INR (INR(max))."( Phase 1 study of the effect of icosapent ethyl on warfarin pharmacokinetic and anticoagulation parameters.
Braeckman, RA; Soni, PN; Stirtan, WG, 2014
)
0.4
" The method was successfully applied to a pharmacokinetic study of EPAEE and DHAEE in healthy Chinese volunteers after the oral administration of 4 g omega-3-acid ethyl esters 90 soft capsule."( LC-APCI-MS/MS assay for quantitation of ethyl esters of eicosapentaenoic acid and docosahexaenoic acid in human plasma and its application in a pharmacokinetic study.
Ding, L; Ji, S; Li, L; Xia, Y; Zhao, S, 2020
)
0.56

Compound-Compound Interactions

ExcerptReferenceRelevance
"The aim of this study was to estimate the cost-effectiveness, from the perspective of the Australian public healthcare system, of icosapent ethyl in combination with statin therapy compared with statin alone for the prevention of cardiovascular disease."( The cost-effectiveness of icosapent ethyl in combination with statin therapy compared with statin alone for cardiovascular risk reduction.
Ademi, Z; Liew, D; Ofori-Asenso, R; Owen, A; Zomer, E, 2021
)
0.62
"A Markov model populated with data from the Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial was designed to predict the effectiveness and costs of icosapent ethyl in combination with statins compared with statins alone over a 20-year time horizon."( The cost-effectiveness of icosapent ethyl in combination with statin therapy compared with statin alone for cardiovascular risk reduction.
Ademi, Z; Liew, D; Ofori-Asenso, R; Owen, A; Zomer, E, 2021
)
0.62
"Compared with statin alone, icosapent ethyl in combination with statin therapy is likely to be cost-effective in the prevention of cardiovascular disease assuming a willingness-to-pay threshold of AUD50,000 per QALY gained, especially in the secondary preventive setting."( The cost-effectiveness of icosapent ethyl in combination with statin therapy compared with statin alone for cardiovascular risk reduction.
Ademi, Z; Liew, D; Ofori-Asenso, R; Owen, A; Zomer, E, 2021
)
0.62
"To assess the cost effectiveness of icosapent ethyl, fenofibrate, ezetimibe, evolocumab, and alirocumab in combination with statins compared to statin monotherapy for cardiovascular prevention from the perspective of UK's National Health Service."( Cost-Effectiveness of Icosapent Ethyl, Evolocumab, Alirocumab, Ezetimibe, or Fenofibrate in Combination with Statins Compared to Statin Monotherapy.
Boch, T; Michaeli, DT; Michaeli, JC; Michaeli, T, 2022
)
0.72

Bioavailability

ExcerptReferenceRelevance
"The high complexity of n-3 fatty acids absorption process, along with the huge amount of endogenous fraction, makes bioavailability studies with these agents very challenging and deserving special consideration."( The free fractions of circulating docosahexaenoic acid and eicosapentenoic acid as optimal end-point of measure in bioavailability studies on n-3 fatty acids.
Levesque, A; Lisi, L; Navarra, P; Scarsi, C, 2015
)
0.42
" OM3CA bioavailability (area under the plasma concentration-time curve from zero to the last measurable concentration) is up to 4-fold greater than that of OM3FA ethyl esters, and unlike ethyl esters, the absorption of OM3CA is not dependent on pancreatic lipase hydrolysis."( The clinical relevance of omega-3 fatty acids in the management of hypertriglyceridemia.
Anzalone, D; Backes, J; Catini, J; Hilleman, D, 2016
)
0.43
"The in vitro dissolution characteristics, oral bioavailability and 48 h plasma profiles of EPA and DHA (as triacylglycerides) of Lys-FFA, relative to a commercially available oil-based EE supplement."( In vitro dissolution behaviour and absorption in humans of a novel mixed l-lysine salt formulation of EPA and DHA.
Balvers, M; Bosi, R; Diepeveen-de Bruin, M; Headley, L; Manusama, K; Schwarm, M; Witkamp, R, 2021
)
0.62
"This first-in-man study of Lys-FFA demonstrated rapid absorption of EPA and DHA and a considerably higher bioavailability compared to an EE supplement under fasting conditions."( In vitro dissolution behaviour and absorption in humans of a novel mixed l-lysine salt formulation of EPA and DHA.
Balvers, M; Bosi, R; Diepeveen-de Bruin, M; Headley, L; Manusama, K; Schwarm, M; Witkamp, R, 2021
)
0.62
" Finally, a summary of current advanced strategies for dealing with the low oxidative stability and low bioavailability of EPA-EE is presented."( Highly Valuable Fish Oil: Formation Process, Enrichment, Subsequent Utilization, and Storage of Eicosapentaenoic Acid Ethyl Esters.
Jin, Q; Karrar, E; Wang, X; Wu, G; Yi, M; You, Y; Zhang, H; Zhang, L; Zhang, Y, 2023
)
1.13

Dosage Studied

ExcerptRelevanceReference
" The decrease from pre-administration values was significant for patients with abnormal values in both dosage groups."( [The effect on changes in serum lipids and factors that may affect those changes after administration of icosapentaenoic acid ethyl ester].
Aoyama, T; Saga, T; Takekoshi, T, 1993
)
0.29
" In addition, we aimed to obtain preliminary information regarding EPA half-life, which is needed to establish an optimal dosing schedule."( Incorporation and washout of orally administered n-3 fatty acid ethyl esters in different plasma lipid fractions.
Dagnelie, PC; Rietveld, T; van den Berg, JW; Wilson, JH; Zuijdgeest-van Leeuwen, SD, 1999
)
0.3
" All of the individual items on all 3 rating scales improved with the 1-g/d dosage of ethyl-eicosapentaenoate vs placebo, with strong beneficial effects on items rating depression, anxiety, sleep, lassitude, libido, and suicidality."( A dose-ranging study of the effects of ethyl-eicosapentaenoate in patients with ongoing depression despite apparently adequate treatment with standard drugs.
Horrobin, DF; Peet, M, 2002
)
0.31
"Treatment with ethyl-eicosapentaenoate at a dosage of 1 g/d was effective in treating depression in patients who remained depressed despite adequate standard therapy."( A dose-ranging study of the effects of ethyl-eicosapentaenoate in patients with ongoing depression despite apparently adequate treatment with standard drugs.
Horrobin, DF; Peet, M, 2002
)
0.31
"Baseline-adjusted steady-state EPA exposure was similar after dosing with OM3-CA 4 g/day versus IPE 4 g/day (LSM ratio, area under the concentration-time curve from time 0 to 24 h: 93."( Systemic Bioavailability and Dose Proportionality of Omega-3 Administered in Free Fatty Acid Form Compared With Ethyl Ester Form: Results of a Phase 1 Study in Healthy Volunteers.
Abu-Rashid, M; Chai, P; Davidson, M; Nilsson, C; Offman, E, 2017
)
0.46
" Blood samples were collected for 24 h after dosing to analyze DHA and EPA plasma concentrations using a validated methodology."( A randomized trial comparing omega-3 fatty acid plasma levels after ingestion of emulsified and non-emulsified cod liver oil formulations.
Burgher-Kennedy, N; Conus, N; Kaur Datta, G; van den Berg, F, 2019
)
0.51
"Knowledge of the diurnal variation in circulating omega-3 polyunsaturated fatty acids (n-3 PUFAs) may be an important consideration for the development of dosing protocols designed to optimise tissue delivery of these fatty acids."( Diurnal rhythm of plasma EPA and DHA in healthy adults.
Avery, H; Calder, PC; Forster, J; Husberg, C; Hustvedt, SO; Jackson, PA; Kennedy, DO; Khan, J, 2020
)
0.56
"0 g/day (2×1 g twice daily) with dosing after standard meals for 28 days."( Pharmacokinetics of Icosapent Ethyl: An Open-Label, Multiple Oral Dose, Parallel Design Study in Healthy Chinese Subjects.
Chen, H; Chen, W; Li, H; Li, J; Li, X; Li, Y; Liu, C; Sheng, L; Xu, H; Yang, M; Yuan, F, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Protein Targets (4)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency6.16550.01237.983543.2770AID1645841
vitamin D (1,25- dihydroxyvitamin D3) receptorHomo sapiens (human)Potency7.49720.023723.228263.5986AID743222
heat shock protein beta-1Homo sapiens (human)Potency29.84700.042027.378961.6448AID743210
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency19.62650.000627.21521,122.0200AID743202; AID743219
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (31)

Assay IDTitleYearJournalArticle
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (407)

TimeframeStudies, This Drug (%)All Drugs %
pre-199016 (3.93)18.7374
1990's56 (13.76)18.2507
2000's60 (14.74)29.6817
2010's157 (38.57)24.3611
2020's118 (28.99)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 29.54

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index29.54 (24.57)
Research Supply Index6.26 (2.92)
Research Growth Index5.32 (4.65)
Search Engine Demand Index50.18 (26.88)
Search Engine Supply Index2.64 (0.95)

This Compound (29.54)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials99 (23.52%)5.53%
Trials0 (0.00%)5.53%
Reviews63 (14.96%)6.00%
Reviews0 (0.00%)6.00%
Case Studies9 (2.14%)4.05%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Observational0 (0.00%)0.25%
Other250 (59.38%)84.16%
Other8 (100.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (32)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomised Placebo-controlled Phase III Trial of the Effect of the Omega-3 Fatty Acid Eicosapentaenoic Acid (EPA) on Colorectal Cancer Recurrence and Survival After Surgery for Resectable Liver Metastases [NCT03428477]Phase 3418 participants (Actual)Interventional2018-05-02Active, not recruiting
Effects of Fish Oil and Physical Activity on Fatigue in Patients With Advanced Cancer [NCT02940223]Phase 22 participants (Actual)Interventional2017-03-16Terminated(stopped due to PI is requesting termination (closure) of this study.)
PREPARE: PRevention Using EPA Against coloREctal Cancer [NCT04216251]Phase 1/Phase 281 participants (Actual)Interventional2020-03-19Completed
Biospecimen Collection for:Prebiotic Effect of Eicosapentaenoic Acid Treatment for Colorectal Cancer Liver Metastases [NCT04682665]250 participants (Anticipated)Observational2021-09-16Recruiting
An Open-label, Single and Repeat Single Ascending Dose Escalation Study to Compare the Pharmacokinetics of Metformin Eicosapentaenoate With Metformin Hydrochloride and Icosapent Ethyl Following Oral Administration to Healthy Volunteers [NCT02113163]Phase 132 participants (Anticipated)Interventional2014-03-31Completed
MND-2119 Phase 3 Study to Evaluate the Efficacy and Safety of MND-2119 Compared to EPADEL CAPSULES 300 in Patients With Hypertriglyceridemia [NCT03693131]Phase 3580 participants (Actual)Interventional2018-10-27Completed
The Icosapent Ethyl and Prevention of Vascular Regenerative Cell Exhaustion Study [NCT04562467]Phase 470 participants (Anticipated)Interventional2020-09-24Active, not recruiting
An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19 (VASCEPA-COVID-19) [NCT04412018]Phase 2100 participants (Actual)Interventional2020-06-04Completed
A Multi-center, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ethyl Icosapentate in Patients With Severe Hypertriglyceridemia [NCT04239950]Phase 3300 participants (Anticipated)Interventional2020-05-09Active, not recruiting
The Effect of Ethyl Eicosapentaenoic Acid on Circulating Low-density Lipoproteins and Plasma Lipid Metabolism in Healthy Volunteers [NCT04152291]50 participants (Anticipated)Interventional2019-11-12Active, not recruiting
Eicosapentaenoic Acid Cerebral Vasospasm Therapy Study (EVAS): Effect of Eicosapentaenoic Acid on Cerebral Vasospasm Following Subarachnoid Hemorrhage [NCT00839449]Phase 4200 participants (Actual)Interventional2004-12-31Completed
Ethyl-EPA Treatment of Prodromal Patients [NCT00634361]Phase 2/Phase 37 participants (Actual)Interventional2001-09-30Completed
An Open-Label, 2-Cohort Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®), to Assess the Dose Proportionality of Epanova™, and to Compare the Systemic Exposure of Eicosapentaenoic Acid [NCT02859129]Phase 1114 participants (Actual)Interventional2013-09-30Completed
Omega-3 Fatty Acids in the Treatment of Major Depression and Bipolar Disorder: A Double-Blind, Placebo-Controlled Trial [NCT00001146]Phase 2240 participants Interventional1999-10-31Completed
Effect of Eicosapentaenoic Acid (EPA) on Major Cardiovascular Events in Hypercholesterolemic Patients: the Japan EPA Lipid Intervention Study (JELIS) [NCT00231738]Phase 418,000 participants Interventional1996-11-30Completed
Vascepa to Accelerate Lipoprotein Uptake and Elimination (VALUE): An Open-Label, Mechanistic, Randomized, Controlled, Single-Center Trial of AMR101 in Patients With Dyslipidemia [NCT03885661]Phase 120 participants (Actual)Interventional2016-01-11Completed
A PET Study With [11C]PBR-28 and an Experimental Medication, Ethyl Eicosapentaenoic Acid [NCT04811404]Phase 40 participants (Actual)Interventional2021-03-19Withdrawn(stopped due to Reassessment of rationale for study)
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 [NCT01047501]Phase 3702 participants (Actual)Interventional2009-12-31Completed
A Double-Blind, Placebo-Controlled Study of Ethyl Eicosapentanoic Acid (Ethyl-EPA) in Major Depressive Disorder [NCT00096798]Phase 380 participants (Anticipated)Interventional2001-09-30Completed
A Multicentre, Placebo-controlled Trial of Eicosapentaenoic Acid (EPA) and Antioxidant Supplementation in the Treatment of Schizophrenia and Related Disorders [NCT00419146]Phase 2/Phase 399 participants (Actual)Interventional2001-09-30Completed
A Multicenter, Double Blind, Randomized, Parallel Group, Placebo-Controlled Trial of Ethyl-EPA (Miraxion™) in Subjects With Mild to Moderate Huntington's Disease [NCT00146211]Phase 3300 participants (Actual)Interventional2005-09-30Completed
Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons With Elevated Triglycerides (200-499) on Statin Therapy [NCT02926027]Phase 480 participants (Actual)Interventional2017-03-28Completed
Mediators of Abnormal Reproductive Function in Obesity [NCT01817400]Early Phase 110 participants (Actual)Interventional2013-03-31Completed
A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE) [NCT04505098]Phase 439,600 participants (Actual)Interventional2020-08-07Terminated(stopped due to The study was suspended by the IRB of record and subsequently terminated)
Evaluation of the Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride Levels ≥ 500 mg/dL and ≤ 2000 mg/dL [NCT01047683]Phase 3229 participants (Actual)Interventional2009-12-31Completed
Pharmacodynamic Effects of a Free-fatty Acid Formulation of Omega-3 Pentaenoic Acid to ENHANCE Efficacy in Adults With Hypertriglyceridemia: The ENHANCE-IT Trial [NCT04177680]Phase 2100 participants (Actual)Interventional2020-06-03Completed
Effects of Eicosapentaenoic Acid on Endothelial Function in Diabetic Subjects: A Pilot Trial [NCT02422446]Phase 32 participants (Actual)Interventional2015-04-30Terminated(stopped due to Difficulty enrolling patients with elevated triglycerides under statin treatment)
Impact of Icosapent Ethyl on Alzheimers Disease Biomarkers in Preclinical Adults [NCT02719327]Phase 2/Phase 3131 participants (Actual)Interventional2017-06-08Completed
Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial) [NCT01492361]Phase 38,179 participants (Actual)Interventional2011-11-30Completed
Phase Ib/II Study of EPA-Based EphA2 Targeted Therapy for Patients With Metastatic Triple-Negative Inflammatory Breast Cancer [NCT05198843]Phase 1/Phase 218 participants (Anticipated)Interventional2022-11-08Recruiting
PREPARE-IT. Prevention and Treatment of COVID19 With EPA in Subjects at Risk - Intervention Trial [NCT04460651]Phase 34,093 participants (Actual)Interventional2020-08-14Completed
OMICC: OMega-3 Fatty Acid for the Immune Modulation of Colorectal Cancer [NCT03661047]Phase 20 participants (Actual)Interventional2019-11-30Withdrawn(stopped due to Study will be closed due to zero enrollment in over 2 years.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01047501 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels
NCT01047501 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels
NCT01047501 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels
NCT01047501 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels
NCT01047501 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
NCT01047501 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
NCT01047683 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels
NCT01047683 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels
NCT01047683 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels
NCT01047683 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels
NCT01047683 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect
NCT01047683 (6) [back to overview]Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels
NCT01492361 (10) [back to overview]Composite of CV Death or Nonfatal MI (Including Silent MI).
NCT01492361 (10) [back to overview]Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
NCT01492361 (10) [back to overview]Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
NCT01492361 (10) [back to overview]CV Death.
NCT01492361 (10) [back to overview]Fatal or Nonfatal MI (Including Silent MI).
NCT01492361 (10) [back to overview]Fatal or Nonfatal Stroke.
NCT01492361 (10) [back to overview]Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.
NCT01492361 (10) [back to overview]Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
NCT01492361 (10) [back to overview]Total Mortality.
NCT01492361 (10) [back to overview]Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
NCT02422446 (1) [back to overview]Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI)
NCT02926027 (2) [back to overview]Progression Rates of Low Attenuation Plaque Under Influence of Vascepa as Compared to Placebo as a Change Between Two or More Time Points
NCT02926027 (2) [back to overview]The Composition of Non-calcified Coronary Atherosclerotic Plaque (NCP)
NCT03885661 (1) [back to overview]Change in VLDL-apoB100 Production Rate
NCT04177680 (5) [back to overview]Percent Change in Plasma Triglycerides (Pharmacodynamic Population)
NCT04177680 (5) [back to overview]Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population)
NCT04177680 (5) [back to overview]Percent Change in Lipoprotein Lipids (Per Protocol Population)
NCT04177680 (5) [back to overview]Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)
NCT04177680 (5) [back to overview]Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels

Median percent change from baseline to Week 12 in serum Apolipoprotein B levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047501)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day1.6
AMR101 (Ethyl Icosapentate) - 4 g/Day-2.2
Placebo7.1

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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels

Median percent change from baseline to Week 12 in serum Lipoprotein-associated Phospholipase A2 levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047501)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day-1.8
AMR101 (Ethyl Icosapentate) - 4 g/Day-12.8
Placebo6.7

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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels

Median percent change from baseline to Week 12 in serum low density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047501)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day2.4
AMR101 (Ethyl Icosapentate) - 4 g/Day1.5
Placebo8.8

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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels

Median percent change from baseline to Week 12 in serum non-high density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047501)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day2.4
AMR101 (Ethyl Icosapentate) - 4 g/Day-5.0
Placebo9.8

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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect

Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047501)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day-5.6
AMR101 (Ethyl Icosapentate) - 4 g/Day-17.5
Placebo5.9

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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels

Median percent change from baseline to Week 12 in serum very low-density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047501)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day1.6
AMR101 (Ethyl Icosapentate) - 4 g/Day-12.1
Placebo15.0

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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Group in Apolipoprotein B Levels

Median in percent change from baseline to Week 12 in serum Apolipoprotein B levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047683)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day2.1
AMR101 (Ethyl Icosapentate) - 4 g/Day-3.8
Placebo4.3

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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels

Median percent change from baseline to Week 12 in serum Lipoprotein-associated Phospholipase A2 levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047683)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day-5.1
AMR101 (Ethyl Icosapentate) - 4 g/Day-17.1
Placebo-2.4

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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels

Median percent change from baseline to Week 12 in serum low density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047683)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day-2.5
AMR101 (Ethyl Icosapentate) - 4 g/Day-4.5
Placebo-3.0

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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels

Median percent change from baseline to Week 12 in serum non-high density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047683)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day0.0
AMR101 (Ethyl Icosapentate) - 4 g/Day-7.7
Placebo7.8

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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect

Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047683)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day-7.0
AMR101 (Ethyl Icosapentate) - 4 g/Day-26.6
Placebo9.7

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Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels

Median percent change from baseline to Week 12 in serum very low-density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day (NCT01047683)
Timeframe: baseline and 12 weeks

InterventionPercent change from baseline (Median)
AMR101 (Ethyl Icosapentate) - 2 g/Day0.0
AMR101 (Ethyl Icosapentate) - 4 g/Day-19.5
Placebo13.7

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Composite of CV Death or Nonfatal MI (Including Silent MI).

Number of patients with a first occurrence of any component of the composite of CV death or nonfatal MI (including silent MI) during the follow-up period. (NCT01492361)
Timeframe: Total follow-up time of up to approximately 6 years.

InterventionParticipants (Count of Participants)
AMR101392
Placebo507

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Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.

The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period. (NCT01492361)
Timeframe: Total follow-up time of up to approximately 6 years.

InterventionParticipants (Count of Participants)
AMR101705
Placebo901

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Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.

The key secondary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period. (NCT01492361)
Timeframe: Total follow-up time of up to approximately 6 years.

InterventionParticipants (Count of Participants)
AMR101459
Placebo606

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CV Death.

Number of patients with an occurrence of CV death during the follow-up period. (NCT01492361)
Timeframe: Total follow-up time of up to approximately 6 years.

InterventionParticipants (Count of Participants)
AMR101174
Placebo213

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Fatal or Nonfatal MI (Including Silent MI).

Number of patients with a first occurrence of fatal or nonfatal MI (including silent MI) during the follow-up period. (NCT01492361)
Timeframe: Total follow-up time of up to approximately 6 years.

InterventionParticipants (Count of Participants)
AMR101250
Placebo355

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Fatal or Nonfatal Stroke.

Number of patients with a first occurrence of fatal or nonfatal stroke during the follow-up period. (NCT01492361)
Timeframe: Total follow-up time of up to approximately 6 years.

InterventionParticipants (Count of Participants)
AMR10198
Placebo134

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Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.

Number of patients with a first occurrence of non-elective coronary revascularization represented as the composite of emergent or urgent classifications during the follow-up period. (NCT01492361)
Timeframe: Total follow-up time of up to approximately 6 years.

InterventionParticipants (Count of Participants)
AMR101216
Placebo321

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Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.

Number of patients with a first occurrence of any component of the composite of total mortality, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period. (NCT01492361)
Timeframe: Total follow-up time of up to approximately 6 years.

InterventionParticipants (Count of Participants)
AMR101549
Placebo690

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Total Mortality.

Number of patients with an occurrence of death from any cause during the follow-up period. (NCT01492361)
Timeframe: Total follow-up time of up to approximately 6 years.

InterventionParticipants (Count of Participants)
AMR101274
Placebo310

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Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.

Number of patients with a first occurrence of unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period. (NCT01492361)
Timeframe: Total follow-up time of up to approximately 6 years.

InterventionParticipants (Count of Participants)
AMR101108
Placebo157

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Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI)

Digital pulse amplitude will be measured with a fingertip peripheral arterial tonometry (PAT) device (Endo-PAT2000, Itamar Medical) in a supine position. Baseline pulse amplitude will be measured for 5 minutes, then the arterial flow will then be interrupted for 5 minutes with a cuff placed on a proximal forearm. Pulse amplitude will be recorded electronically and analyzed by a computerized and automated algorithm. The change from the baseline measurement will be expressed as the reactive hyperemia index (RHI). We will calculate the pulse amplitude response to hyperemia for each 30-second interval as a ratio of the post-deflation pulse amplitude to the baseline pulse amplitude as described previously. The RHI ratio will be computed by dividing the ratio obtained on the test side over the ratio from the control finger. We will assess change in RHI ratio between baseline value and 12-week value after the intervention. (NCT02422446)
Timeframe: Between baseline and 12 weeks

Intervention% change from baseline value (Mean)
EPA Arm-29
Control-1.6

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Progression Rates of Low Attenuation Plaque Under Influence of Vascepa as Compared to Placebo as a Change Between Two or More Time Points

low attenuation plaque volume change from baseline to 18 months (NCT02926027)
Timeframe: 18 months

Interventionvolume in mm cubed (Mean)
Active Subjects-0.3
Placebo Subject0.9

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The Composition of Non-calcified Coronary Atherosclerotic Plaque (NCP)

the measure is reported as volume of non-calcified plaque, as the secondary measure has been reported. (NCT02926027)
Timeframe: 18 months

InterventionMM CUBED (Mean)
Active Subjects-0.8
Placebo Subject0.3

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Change in VLDL-apoB100 Production Rate

The production rate of very low-density lipoprotein apolipoprotein B100 as determined by stable-isotope lipid kinetics techniques based on a primed constant infusion of deuterated leucine. (NCT03885661)
Timeframe: ≥ 13 weeks of observation on randomized treatment assignment

,
Interventionmg VLDL apoB100 / kg body weight per day (Mean)
L apoB100 Production Rate (Baseline)VLDL apoB100 Production Rate (Treatment)
Icosapent Ethyl21.721.3
Usual Care14.917.2

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Percent Change in Plasma Triglycerides (Pharmacodynamic Population)

Percent change in triglycerides from baseline to end of treatment in the pharmacodynamic population (NCT04177680)
Timeframe: baseline to 28 days

InterventionPercent Change from baseline (Median)
Omega-3 Pentaenoic Acid (MAT9001)-20.9
Icosapent Ethyl (Vascepa)-18.3

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Percent Change From Baseline in Omega-3 Fatty Acid Concentrations (Pharmacodynamic Population)

The percent change from baseline in Omega-3 fatty acid concentrations in the Pharmacodynamic population (NCT04177680)
Timeframe: Baseline to 28 days

,
InterventionPercent Change from baseline (Median)
Eicosapentaenoic acid (EPA)Docosahexaenoic acid (DHA)Docosapentaenoic acid (DPA)EPA + DHA + DPA
Icosapent Ethyl (Vascepa)692-3.3140165
Omega-3 Pentaenoic Acid (MAT9001)8481.7177205

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Percent Change in Lipoprotein Lipids (Per Protocol Population)

Percent change from baseline in lipoprotein lipids in the per protocol population (NCT04177680)
Timeframe: baseline to 28 days

,
InterventionPercent Change from baseline (Median)
TriglyceridesTotal CholesterolLDL-CholesterolHDL-CholesterolVLDL-CholesterolNon-HDL-Cholesterol
Icosapent Ethyl (Vascepa)-15.1-3.5-2.8-1.3-10.9-4.4
Omega-3 Pentaenoic Acid (MAT9001)-20-5.7-4.8-2.4-15-6.9

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Percent Change in Other Plasma Lipoprotein Lipids (Pharmacodynamic Population)

Percent change in other lipoprotein lipids from baseline to end of treatment in the pharmacodynamic population (NCT04177680)
Timeframe: baseline to 28 days

,
InterventionPercent Change from baseline (Median)
Total CholesterolLow density lipoprotein (LDL)-CholesterolHigh density lipoprotein (HDL)-CholesterolVery low density lipoprotein (VLDL)-Cholesterolnon-HDL-Cholesterol
Icosapent Ethyl (Vascepa)-4.1-3.1-1.1-13.3-5.2
Omega-3 Pentaenoic Acid (MAT9001)-5.6-4.8-1.7-15.5-7

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Percent Changes in Apolipoproteins, PCSK9 and Hs-CRP (Pharmacodynamic Population)

The percent change from baseline in Apolipoproteins, PCSK9 and hs-CRP in the PD Population (NCT04177680)
Timeframe: baseline to 28 days

,
InterventionPercent Change from baseline (Median)
Apolipoprotein (Apo) A1Apo BApo C3Proprotein convertase subtilisin/kexin type 9 (PCSK9)High-sensitivity C-reactive protein (hs-CRP)
Icosapent Ethyl (Vascepa)-3.1-2.5-11.1-7.38.5
Omega-3 Pentaenoic Acid (MAT9001)-4-3.5-12.4-6.6-5.8

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