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Eliot A Brinton, Christie M Ballantyne, John R Guyton, Sephy Philip, Ralph T Doyle, Rebecca A Juliano, Lori Mosca
BACKGROUND: High triglycerides (TG) and diabetes mellitus type 2 (DM2) are stronger predictors of cardiovascular disease (CVD) in women than in men, but few randomized, controlled clinical trials have investigated lipid-lowering interventions in women and none have reported results specifically in women with high TG and DM2. Icosapent ethyl (Vascepa) is pure prescription eicosapentaenoic acid (EPA) ethyl ester approved at 4 g/day as an adjunct to diet to reduce TG ≥500 mg/dL. METHODS: The 12-week ANCHOR trial randomized 702 statin-treated patients (73% with DM; 39% women) at increased CVD risk with TG 200-499 mg/dL despite controlled low-density lipoprotein cholesterol (LDL-C; 40-99 mg/dL) to receive icosapent ethyl 2 g/day, 4 g/day, or placebo...
March 27, 2018: Journal of Women's Health
Matthew Budoff, J Brent Muhlestein, Viet T Le, Heidi T May, Sion Roy, John R Nelson
Despite reducing progression and promoting regression of coronary atherosclerosis, statin therapy does not fully address residual cardiovascular (CV) risk. High-purity eicosapentaenoic acid (EPA) added to a statin has been shown to reduce CV events and induce regression of coronary atherosclerosis in imaging studies; however, data are from Japanese populations without high triglyceride (TG) levels and baseline EPA serum levels greater than those in North American populations. Icosapent ethyl is a high-purity prescription EPA ethyl ester approved at 4 g/d as an adjunct to diet to reduce TG levels in adults with TG levels >499 mg/dL...
January 2018: Clinical Cardiology
Eliot A Brinton, R Preston Mason
The omega-3 fatty acid eicosapentaenoic acid (EPA) has multiple actions potentially conferring cardiovascular benefit, including lowering serum triglyceride (TG) and non-high-density lipoprotein cholesterol (non-HDL-C) levels and potentially reducing key steps in atherogenesis. Dietary supplements are a common source of omega-3 fatty acids in the US, but virtually all contain docosahexaenoic acid (DHA) in addition to EPA, and lipid effects differ between DHA and EPA. Contrary to popular belief, no over-the-counter omega-3 products are available in the US, only prescription products and dietary supplements...
January 31, 2017: Lipids in Health and Disease
James R Crandell, Christina Tartaglia, Joseph Tartaglia
OBJECTIVES: Residual cardiovascular risk and persistently elevated triglycerides (TGs) may remain despite statin therapy in patients with dyslipidemia. Prescription omega-3 fatty acid formulations containing docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA) have been shown to reduce TGs and may potentially lower residual cardiovascular risk. However, DHA may raise low-density lipoprotein cholesterol (LDL-C) and compromise treatment goals. Icosapent ethyl (Vascepa®), a high-purity prescription EPA formulation, has been shown to lower TGs and other lipid parameters without raising LDL-C...
November 2016: Postgraduate Medicine
James Backes, Deborah Anzalone, Daniel Hilleman, Julia Catini
Hypertriglyceridemia (triglycerides > 150 mg/dL) affects ~25 % of the United States (US) population and is associated with increased cardiovascular risk. Severe hypertriglyceridemia (≥ 500 mg/dL) is also a risk factor for pancreatitis. Three omega-3 fatty acid (OM3FA) prescription formulations are approved in the US for the treatment of adults with severe hypertriglyceridemia: (1) OM3FA ethyl esters (OM3EE), a mixture of OM3FA ethyl esters, primarily eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (Lovaza®, Omtryg™, and generics); (2) icosapent ethyl (IPE), EPA ethyl esters (Vascepa®); and (3) omega-3 carboxylic acids (OM3CA), a mixture of OM3FAs in free fatty acid form, primarily EPA, DHA, and docosapentaenoic acid (Epanova®)...
July 22, 2016: Lipids in Health and Disease
Anurag W Kedia, Erin Lynch
In patients with dyslipidemia, elevated triglyceride (TG) levels, or TG-rich lipoproteins, and cardiovascular risk may remain despite statin therapy. Prescription omega-3 fatty acid formulations containing the ethyl esters of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) (omega-3-acid ethyl esters; Lovaza®) or high-purity EPA ethyl ester (icosapent ethyl; Vascepa®) are TG-lowering treatments that may be administered in addition to statins. Here we describe the effects of switching from omega-3-acid ethyl esters to icosapent ethyl in a 44-year-old obese man with dyslipidemia, hypertension, and hypothyroidism...
2015: Postgraduate Medicine
Esther S Kim, Paul L McCormack
Icosapent ethyl (Vascepa®) is a high-purity ethyl ester of eicosapentaenoic acid (EPA) that is de-esterified to EPA following oral administration. Both EPA and docosahexaenoic acid (DHA) are long-chain omega-3 fatty acids that have been associated with triglyceride (TG)-lowering. However, DHA has been associated with increased low-density lipoprotein cholesterol (LDL-C) levels. Icosapent ethyl contains ≥96 % of the EPA ethyl ester, does not contain DHA, and is approved in the USA for use as an adjunct to diet to lower TG levels in adult patients with severe (≥500 mg/dL [≥5...
December 2014: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
Howard S Weintraub
Patients with elevated triglycerides (TG) may be at a higher risk for cardiovascular (CV) disease. Omega-3 fatty acids (OM3FAs), particularly the long-chain fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), effectively reduce TG and thus may impact CV outcomes; however, clinical data have been inconsistent. This review discusses the efficacy, safety, and key considerations of currently approved prescription OM3FA products in patients with elevated TG with or without concomitant elevations in other atherogenic parameters...
November 2014: Postgraduate Medicine
William R Hiatt, Robert J Smith
On October 16, 2013, the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration (FDA) voted 9 to 2 against approval of Vascepa, a purified n–3 fatty acid formulation of ethyl eicosapentaenoic acid (EPA), for use as an adjunct to diet and in combination with a..
January 30, 2014: New England Journal of Medicine
J Chris Bradberry, Daniel E Hilleman
The triglyceride (TG)-lowering benefits of the very-long-chain omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are well documented. Available as prescription formulations and dietary supplements, EPA and DHA are recommended by the American Heart Association for patients with coronary heart disease and hypertriglyceridemia. Dietary supplements are not subject to the same government regulatory standards for safety, efficacy, and purity as prescription drugs are; moreover, supplements may contain variable concentrations of EPA and DHA and possibly other contaminants...
November 2013: P & T: a Peer-reviewed Journal for Formulary Management
Scott D Nelson, Mark A Munger
OBJECTIVES: To review the pharmacology, pharmacokinetics, clinical trial data, adverse effects, and formulary considerations of icosapent ethyl for the treatment of high triglyceride (TG) levels. DATA SOURCES: A literature search with keywords Vascepa, icosapent ethyl, AMR101, and eicosapentaenoic acid of articles up to July 2013, along with the package insert for Vascepa and current guidelines for hypertriglyceridemia. STUDY SELECTION/DATA EXTRACTION: Two phase-III, placebo-controlled, randomized, double-blind, 12-week clinical trials were included in this review: the MARINE trial and ANCHOR study...
November 2013: Annals of Pharmacotherapy
Manouchkathe Cassagnol, Danielle Ezzo, Priti N Patel
Hypercholesterolemia affects over 34 million adults in the United States and is a major cause of coronary heart disease (CHD). Conventional therapies, such as statins, have demonstrated their ability to improve clinical end points and decrease morbidity and mortality in patients with CHD. Lomitapide (Juxtapid(®)), mipomersen (Kynamro(®)), and icosapent (Vascepa(®)) are 3 novel agents approved by the US Food and Drug Administration in the past 2 years, which offer new lipid-lowering treatment options with unique pharmacology...
December 2013: Journal of Pharmacy Practice
(no author information available yet)
No abstract text is available yet for this article.
April 29, 2013: Medical Letter on Drugs and Therapeutics
Christie M Ballantyne, Rene A Braeckman, Paresh N Soni
INTRODUCTION: Icosapent ethyl (IPE; Vascepa) is a high-purity prescription form of eicosapentaenoic acid (EPA) ethyl ester recently approved in 2012 to reduce triglyceride (TG) levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Elevated TG levels are associated with increased risk for coronary heart disease. Currently available TG-lowering agents (fibrates, niacins, omega-3 fatty acid products containing both EPA and docosahexaenoic acid [DHA]) may be associated with adverse effects such as flushing, hepatotoxicity, myopathy, elevated glucose levels, and/or increases in low-density lipoprotein cholesterol (LDL-C)...
July 2013: Expert Opinion on Pharmacotherapy
Marvin M Goldenberg
Lorcaserin (Belviq), an appetite suppressant; pertuzumab (Perjeta) for HER-2- positive metastatic breast cancer; MenHibrix vaccine for meningococcal infections and influenza; icosapent ethyl (Vascepa) for reducing triglycerides; and aclidinium inhalation (Tudorza) powder for bronchospasm in COPD.
September 2012: P & T: a Peer-reviewed Journal for Formulary Management
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