Cardiovascular disease and omega-3s: Prescription products and fish oil dietary supplements are not the same

Abstract

Background and purpose Despite achievement of optimal low‐density lipoprotein cholesterol (LDL‐C) control with statin therapy, patients with elevated triglycerides (TGs) and residual cardiovascular risk are commonly encountered in clinical practice. Methods We present information from completed and ongoing clinical trials examining Rx omega‐3s for TG‐lowering and omega‐3 dietary supplements to highlight important differences affecting patient management for nurse practitioners. Conclusions Rx omega‐3s demonstrate robust reductions in TGs and may have a role in reducing residual cardiovascular risk. Products containing docosahexaenoic acid (DHA) may raise LDL‐C and should not be substituted for Rx eicosapentaenoic acid (EPA)‐only icosapent ethyl, which does not raise LDL‐C. Omega‐3 dietary supplements (e.g., fish oils containing EPA and DHA) may be used for general health promotion; however, they are not regulated as medications and concerns regarding quality, purity, safety, and variability of content exist. It is important to advise patients that omega‐3 dietary supplements are not medications and should not be substituted for Rx omega‐3s. Large‐scale cardiovascular outcomes studies are underway for Rx omega‐3s in statin‐treated patients. Implications for practice Nurse practitioners can take an active role in reducing residual cardiovascular risk and educating patients about important differences between Rx omega‐3s and fish oil supplements.

Fatty Acid Treatment with Pure Omega-3 Eicosapentaenoic Acid Ethyl Ester for Patients with Cardiovascular Diseases: Differences between Branded (EPADEL®) and Generic Products

“…Currently, n-3 acid ethyl esters containing both high purity ethyl esters of EPA and DHA, and icosapent ethyl being high purity prescription form of EPA ethyl ester are available as n-3 fatty acid prescription products along with their generic alternatives [2] [9]. The generics are widely available and low priced pharmaceutical products but the quality of the main component and the composition of the additives are not fully transparent.…”

“…There was a clear difference between EPA and DHA concerning the reduction in the risk of stroke from large artery atherosclerosis. This may be related to the fact that DHA increases LDL cholesterol [16]. However, as highly purified EPA ethyl ester reduces the DHA level, this speculation may not be valid.…”

Knowledge, Perceptions, and Patterns of Fish Oil Use in Cardiac Patients

“…Omega-3 dietary supplements are not approved by the FDA as treatments for any disease. 4 , 12 , 14 , 15 The only FDA-approved indication for omega-3 prescription products is to treat severe hypertriglyceridemia (triglyceride levels of ≥500 mg/dL). This indication includes a recommended daily dose of 2 to 4 g of prescription quality omega-3 fatty acids.…”

“…There are several general but important distinctions between dietary supplements and products classified as OTC or prescription medications that patients and health-care professionals may be unaware of, including differences in regulation, manufacturing, product purity/quality, and product labeling/content. 4 , 12 , 14 , 15 It is critical to note that dietary supplements are not categorized as OTC products. 12 , 15 It is also important to understand that dietary supplements are not subject to the same manufacturing standards and quality controls as OTC medications.…”

“…4 , 12 , 14 , 15 It is critical to note that dietary supplements are not categorized as OTC products. 12 , 15 It is also important to understand that dietary supplements are not subject to the same manufacturing standards and quality controls as OTC medications. 4 , 12 , 15 Manufacturers of dietary supplements are not required to demonstrate the safety or effectiveness of their products prior to marketing.…”