Efficacy and Safety of Eicosapentaenoic Acid Ethyl Ester (AMR101) Therapy in Statin-Treated Patients With Persistent High Triglycerides (from the ANCHOR Study)

Ballantyne, Christie M.; Bays, Harold; Kastelein, John J.P.; Stein, Evan A.; Isaacsohn, Jonathan L.; Braeckman, René; Soni, Paresh N.

doi:10.1016/j.amjcard.2012.05.031

Cited by 300 publications

(289 citation statements)

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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%

“…Icosapent ethyl 12‐week dosing at 4 g/d in a high‐risk population similar to that within the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE‐IT) who had persistent elevations of TG after treatment with statins resulted in significant reductions in TG and atherogenic lipoproteins,26, 27, 28 as well as comparable plasma EPA levels as the 1.8 g/d dosing group in JELIS 34. Therefore, a dose of 4 g/d was selected as the dose for further study.…”

Section: Introductionmentioning

confidence: 98%

“…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. In this range of very elevated TG levels, reduction is considered to be clinically necessary to decrease the risk of pancreatitis.…”

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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