Icosapent Ethyl, a Pure Ethyl Ester of Eicosapentaenoic Acid: Effects on Circulating Markers of Inflammation from the MARINE and ANCHOR Studies

Bays, Harold; Ballantyne, Christie M.; Braeckman, René; Stirtan, William G.; Soni, Paresh N.

doi:10.1007/s40256-012-0002-3

Cited by 126 publications

(102 citation statements)

References 37 publications

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“…Furthermore, TG reduction lowers several inflammatory markers associated with CV risk, and subgroup and post hoc analyses of outcome studies suggest possible reductions in major CV events with TG‐lowering therapy 3, 4, 5, 6, 7, 8, 9, 10, 11. Finally, studies administering higher‐dose EPA suggest additional beneficial effects beyond lipid‐lowering that may be unique to EPA relative to other TG‐lowering therapies, such as beneficial changes in coronary plaque characteristics, which may lead to reductions in major CV events 4, 16, 25, 26, 27, 28, 29, 30, 31, 32, 33…”

Section: Discussionmentioning

confidence: 99%

“…Omega‐3 therapies, including EPA, have been postulated to have cardioprotective effects such as beneficial changes to TG and other lipid and lipoprotein parameters (eg, non–high‐density lipoprotein cholesterol [non‐HDL‐C], apolipoprotein CIII), as well as other potential benefits beyond plasma lipid modification 19, 25, 26, 27, 28, 29, 30. Icosapent ethyl (Vascepa; Amarin Pharma Inc., Bedminster, NJ) is a highly purified ethyl ester of EPA, which has been reported to improve atherogenic dyslipidemia characterized by reductions in TG, TG‐rich lipoproteins, and factors involved in their metabolism, without raising LDL‐C 25, 26, 27, 28, 29.…”

Section: Introductionmentioning

confidence: 99%

“…Icosapent ethyl (Vascepa; Amarin Pharma Inc., Bedminster, NJ) is a highly purified ethyl ester of EPA, which has been reported to improve atherogenic dyslipidemia characterized by reductions in TG, TG‐rich lipoproteins, and factors involved in their metabolism, without raising LDL‐C 25, 26, 27, 28, 29. Based on trials with TG lowering as the primary endpoint, this prescription therapy is currently approved for use in the United States by the US Food and Drug Administration (FDA) as an adjunct to diet to reduce TG levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL) 25, 26.…”

Section: Introductionmentioning

confidence: 99%

“…In addition to beneficial changes to TG‐rich lipoproteins and other plasma lipid markers, some clinical studies with higher‐dose EPA also suggest beneficial effects on markers of oxidation and inflammation, coronary plaque characteristics, and major CV events 16, 25, 26, 29, 31, 32, 33. For example, in contrast to the fenofibrate and niacin studies, JELIS found a 19% relative risk reduction in CV events in statin‐treated patients with relatively normal TG but a more pronounced 53% reduction in the subgroup with mixed dyslipidemia, specifically TG ≥150 mg/dL and HDL‐C <40 mg/dL 4, 16.…”

Section: Introductionmentioning

confidence: 99%

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Rationale and design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial

Bhatt

Steg

Brinton

et al. 2017

Clinical Cardiology

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Residual cardiovascular risk persists despite statins, yet outcome studies of lipid‐targeted therapies beyond low‐density lipoprotein cholesterol (LDL‐C) have not demonstrated added benefit. Triglyceride elevation is an independent risk factor for cardiovascular events. High‐dose eicosapentaenoic acid (EPA) reduces triglyceride‐rich lipoproteins without raising LDL‐C. Omega‐3s have postulated pleiotropic cardioprotective benefits beyond triglyceride‐lowering. To date, no large, multinational, randomized clinical trial has proved that lowering triglycerides on top of statin therapy improves cardiovascular outcomes. The Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE‐IT; NCT01492361) is a phase 3b randomized, double‐blinded, placebo‐controlled trial of icosapent ethyl, a highly purified ethyl ester of EPA, vs placebo. The main objective is to evaluate whether treatment with icosapent ethyl reduces ischemic events in statin‐treated patients with high triglycerides at elevated cardiovascular risk. REDUCE‐IT enrolled men or women age ≥45 years with established cardiovascular disease or age ≥50 years with diabetes mellitus and 1 additional risk factor. Randomization required fasting triglycerides ≥150 mg/dL and <500 mg/dL and LDL‐C >40 mg/dL and ≤100 mg/dL with stable statin (± ezetimibe) ≥4 weeks prior to qualifying measurements. The primary endpoint is a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina. The key secondary endpoint is the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Several secondary, tertiary, and exploratory endpoints will be assessed. Approximately 8000 patients have been randomized at approximately 470 centers worldwide. Follow‐up will continue in this event‐driven trial until approximately 1612 adjudicated primary‐efficacy endpoint events have occurred.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Rationale and design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial

Bhatt

Steg

Brinton

et al. 2017

Clinical Cardiology

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173

129

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“…Data from phase 3 randomized clinical studies in patients with hypertriglyceridemia (the MARINE and ANCHOR studies) demonstrate that icosapent ethyl has a range of beneficial effects on atherogenic parameters including reductions in the levels of TGs, non-HDL-C, apo B, apoC-III, RLP-C, and markers of atherosclerotic inflammation (i.e. ox-LDL, lipoprotein-associated phospholipase A 2 , and high-sensitivity C-reactive protein) without raising levels of LDL-C compared with placebo [7][8][9][10][11][12][13].…”

Section: Effects Of Epa On Lipids and Lipoproteinsmentioning

confidence: 99%

Can pleiotropic effects of eicosapentaenoic acid (EPA) impact residual cardiovascular risk?

Nelson¹,

True

et al. 2017

Postgraduate Medicine

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Residual cardiovascular (CV) risk persists even in statin-treated patients with optimized low-density lipoprotein cholesterol (LDL-C) levels. Other pathways beyond cholesterol contribute to CV risk and the key to reducing residual risk may be addressing non-cholesterol risk factors through pleiotropic mechanisms. The purpose of this review is to examine the literature relating to the potential role of the omega-3 fatty acid eicosapentaenoic acid (EPA) in reducing residual CV risk. The literature shows that EPA can robustly lower plasma triglyceride (TG) levels without raising LDL-C levels and documents EPA to have a broad range of beneficial effects on the atherosclerotic pathway, including those on lipids, lipoproteins, inflammation, oxidation, phospholipid membranes, and the atherosclerotic plaque itself. Clinical imaging studies have consistently demonstrated that EPA decreases plaque vulnerability and prevents plaque progression. The evidence therefore points to a potential role for EPA to reduce residual CV risk. A large randomized study of statin-treated Japanese patients demonstrated that EPA ethyl ester reduced major coronary events by 19% (P = 0.011). However, while there has been significant benefit demonstrated in this and another Japanese CV outcomes study, the question as to whether EPA can play a role in reducing residual CV risk remains to be addressed in broader populations. The large, global, ongoing, randomized, placebo-controlled REDUCE-IT study of high-risk statin-treated patients with persistent hypertriglyceridemia is currently underway to investigate the potential of icosapent ethyl (high-purity prescription EPA ethyl ester) as an add-on therapy to reduce residual CV risk. ARTICLE HISTORY

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Marine-derived n-3 fatty acids therapy for stroke

Campano

MacLeod

Aucott

et al. 2019

Cochrane Database of Systematic Reviews

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Icosapent Ethyl, a Pure Ethyl Ester of Eicosapentaenoic Acid: Effects on Circulating Markers of Inflammation from the MARINE and ANCHOR Studies

Cited by 126 publications

References 37 publications

Rationale and design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial

Rationale and design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial

Can pleiotropic effects of eicosapentaenoic acid (EPA) impact residual cardiovascular risk?

Marine-derived n-3 fatty acids therapy for stroke

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