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A Comparative Overview of Prescription Omega-3 Fatty Acid Products.

ABSTRACT: An estimated 25% of adults in the United States have elevated triglyceride (TG) levels. This is of particular concern given the evidence for a causal role of TG in the pathway of cardiovascular (CV) disease. Approved prescription omega-3 fatty acid products (RxOM3FAs) contain the long-chain fatty acids docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA) and are effective options for the treatment of high TG levels. RxOM3FAs that contain both EPA and DHA include omega-3-acid ethyl esters (ethyl esters of EPA and DHA; brand and generic products) and omega-3-carboxylic acids (free fatty acids primarily composed of EPA and DHA), while the RxOM3FA icosapent ethyl (the ethyl ester of EPA) contains EPA only. All RxOM3FA products produce substantial TG reduction and other beneficial effects on atherogenic lipid and inflammation-related parameters, blood pressure, and heart rate variability, but products that contain DHA may raise low-density lipoprotein-cholesterol (LDL-C). This commentary provides an overview of hypertriglyceridemia while summarizing the pharmacology, efficacy, and safety of prescription RxOM3FAs.

SUBMITTER: Ito MK

PROVIDER: S-EPMC4671468 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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A Comparative Overview of Prescription Omega-3 Fatty Acid Products.

Ito Matthew K MK

P & T : a peer-reviewed journal for formulary management 20151201 12

An estimated 25% of adults in the United States have elevated triglyceride (TG) levels. This is of particular concern given the evidence for a causal role of TG in the pathway of cardiovascular (CV) disease. Approved prescription omega-3 fatty acid products (RxOM3FAs) contain the long-chain fatty acids docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA) and are effective options for the treatment of high TG levels. RxOM3FAs that contain both EPA and DHA include omega-3-acid ethyl ester ...[more]

PMID: 26681905

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Project description:Type 2 diabetes mellitus (T2DM) and metabolic syndrome contribute to hypertriglyceridemia, which may increase residual risk of cardiovascular disease in patients with elevated triglyceride (TG) levels despite optimal low-density lipoprotein cholesterol (LDL-C) levels with statin therapy. Prescription products containing the long-chain omega-3 fatty acids (OM3FAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are an effective strategy for reducing TG levels. This article provides an overview of prescription OM3FAs, including relevant clinical data in patients with T2DM and/or metabolic syndrome. Prescription OM3FAs contain either combinations of DHA and EPA (omega-3-acid ethyl esters, omega-3-carboxylic acids, omega-3-acid ethyl esters A) or EPA alone (icosapent ethyl). These products are well tolerated and can be used safely with statins. Randomized controlled trials have demonstrated that all prescription OM3FAs produce statistically significant reductions in TG levels compared with placebo; however, differential effects on LDL-C levels have been reported. Products containing DHA may increase LDL-C levels, whereas the EPA-only product did not increase LDL-C levels compared with placebo. Because increases in LDL-C levels may be unwanted in patients with T2DM and/or dyslipidemia, the EPA-only product should not be replaced with products containing DHA. Available data on the effects of OM3FAs in patients with diabetes and/or metabolic syndrome support that these products can be used safely in patients with T2DM and have beneficial effects on atherogenic parameters; in particular, the EPA-only prescription product significantly reduced TG, non-high-density lipoprotein cholesterol, Apo B, remnant lipoprotein cholesterol, and high-sensitivity CRP levels without increasing LDL-C levels compared with placebo. Ongoing studies of the effects of prescription OM3FAs on cardiovascular outcomes will help determine whether these products will emerge as effective add-on options to statin therapy for reduction of residual cardiovascular disease risk.

Project description:Study questionIs self-reported use of omega-3 fatty acid supplements associated with fecundability, the probability of natural conception, in a given menstrual cycle?Summary answerProspectively recorded omega-3 supplement use was associated with an increased probability of conceiving.What is known alreadyIn infertile women, omega-3 fatty acid intake has been associated with increased probability of pregnancy following IVF. In natural fertility, studies are conflicting, and no study of natural fertility has evaluated omega-3 fatty acid supplementation and fecundity.Study design, size, durationSecondary data analysis of 900 women contributing 2510 cycles in Time to Conceive (TTC), a prospective, time to pregnancy cohort study from 2008 to December 2015.Participants/materials, setting, methodsWomen aged 30-44 years, trying to conceive <3 months, without history of infertility were followed using standardized pregnancy testing. While attempting to conceive, women daily recorded menstrual cycle events and supplement and medication intake using the Cerner Multum Drug Database. Supplements and vitamins containing omega-3 were identified. Omega-3 use, defined as use in at least 20% of days in a given menstrual cycle, in each pregnancy attempt cycle was determined. A discrete-time Cox proportional hazards model was used to calculate the fecundability ratio.Main results and the role of chanceWomen taking omega-3 supplementation were more likely to be younger, thinner, nulligravid, white and to take vitamin D, prenatal and multivitamins compared to women not taking omega-3s. After adjusting for age, obesity, race, previous pregnancy, vitamin D and prenatal and multivitamin use, women taking omega-3 supplements had 1.51 (95% CI 1.12, 2.04) times the probability of conceiving compared to women not taking omega-3s.Limitations, reasons for cautionOur study was not a randomized controlled trial. The women who used omega-3 supplements may represent a more health-conscious population. We sought to address this by adjusting for multiple factors in our model. Additionally, the omega-3 fatty acid supplements that TTC participants used included multiple types and brands with varying dosages of omega-3 fatty acids. Women reported the type of supplement they were taking but not the concentration of omega-3s in that supplement. It is therefore not possible to compare dosing or a dose-response relationship in our study.Wider implications of the findingsOmega-3 supplementation may present a feasible and inexpensive modifiable factor to improve fertility. Randomized controlled trials are needed to further investigate the benefits of omega-3 supplementation for women trying to conceive naturally.Study funding/competing interestsThis study was supported by the Division of Reproductive Endocrinology and Infertility at the University of North Carolina at Chapel Hill, the NIH/NICHD (R21 HD060229-01 and R01 HD067683-01), and in part by the Intramural Research Program of the National Institute of Environmental Health Sciences (Z01ES103333). The authors declare that there is no conflict of interest.Trial registration numberN/A.

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A Comparative Overview of Prescription Omega-3 Fatty Acid Products.

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A Comparative Overview of Prescription Omega-3 Fatty Acid Products.

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