A Prescription Formulation Of Omega-3 Fatty Acids

Omega-3-acid ethyl esters (P-OM3; LOVAZA Capsules) is a lipid-lowering agent to be used in conjunction with diet for the reduction of severe hypertriglyceridemia in adults ( 500 mg/dL [ 5.65 mmol/L]) [8a]. P-OM3 is the only prescription formulation of omega-3 fatty acids available in the United States (Table 1). The quality of P-OM3, as with all prescription agents as described earlier, is subject to current GMP standards of con-sistency and purity. In the prescription formulation of P-OM3, a patented (International Patent Number WO2004/007654 A1), FDA-monitored purification process is used. This process re-sults in a uniform omega-3 fatty acid concentration of 90%. Concentrations of heavy metals, dioxins, and halogenated poly-carbons are not detectable [8]. The EPA and DHA content in P-OM3 is entirely marine derived, and the purification process is applied to refine, esterify, purify, and blend the ethyl esters to yield a concentrated form of EPA and DHA. Each capsule of P-OM3 contains EPA 465 mg/g and DHA 375 mg/g . The omega-3 fatty acids contained in P-OM3 allow more concen-trated dosing per capsule than dietary supplement formulations (Table 3 and Fig. 1). The high concentrations of omega-3-acid ethyl esters ( 80%) available in P-OM3 reduce triglyc-eride levels more effectively and appear to have greater bio-availability than less-concentrated formulations.

In general, dietary supplement omega-3 fatty acids contain only modest concentrations of EPA and DHA (Table 3). An independent analysis of 41 omega-3 fatty acid dietary supplements found that most products met label claims, although the contents of one product were spoiled, while a second dietary supplement omega-3 product contained only 53% of its claimed EPA content. Dietary supplement omega-3 fatty acids typically do not contain toxins, such as mercury, polychlorinated biphenyls, di-oxin, and other contaminants, in sufficient concentrations to pose a potential health risk (reviewed in Bays, 2007). However, some dietary-supplement omega-3 fatty acids, at amounts attempt-ing to achieve EPA and DHA content approximating that of four P-OM3 capsules, require the use of up to 18 capsules daily. This has important clinical implications, as the quantity of prescribed medications may be inversely correlated with patient compliance. Thus, the high concentrations of omega-3-acid ethyl esters in P-OM3 may foster better patient compliance com-pared with less-concentrated formulations.

In 2001 the United States Pharmacopeial Convention, Inc. Although the USP verification program does not accept dietary supplements that contain an ingredient with known safety concerns, it does not comprehen-sively address issues of safety and efficacy. Data on the efficacy and safety of dietary supplement omega-3 fatty acids may be lacking, insufficient, or inconsistent. One study, the diet and rein-farction trial (DART), showed that subjects advised to eat fatty fish had a 29% reduction in 2-year all-cause mortality compared with subjects not given dietary advice. Notably, subjects who took a fish oil supplement as a partial or total substitute for fatty fish showed the same benefit as subjects who ate fatty fish. In addition, the FDA-Qualified Health Claim for dietary supplements that contain omega-3 fatty acids (Table 1) does offer some over-sight for safety concerns.

The efficacy and safety of P-OM3 for the treatment of hypertriglyceridemia has been studied extensively in clinical trials. The recommended daily dosage of P-OM3 is 4 g/day, taken as a single dose of 4 capsules or 2 divided doses of 2 capsules [8a]. Claims that a dietary supplement omega-3 fatty acid product is “pharmaceutical grade” do not reflect credible safety and efficacy data unless the product is approved by the FDA as a prescription pharmaceutical [40]. Importantly, patients should discuss the choice of treatment of hypertriglyceridemia with a qualified health professional. At this time, P-OM3 is the only FDA-approved omega-3 fatty acid formulation for the treatment of hypertriglyceridemia.

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There are important qualitative and quantitative differences between the FDA-approved P-OM3 and dietary supplement omega-3 fatty acids. Both consumers and medical professionals should be aware that dietary supplement omega-3 fatty acids may not have the same efficacy and safety profile as P-OM3. Notably, the efficacy and safety of P-OM3 have been demon-strated in randomized, placebo-controlled trials. The FDA has advised that no more than 2 g/day of EPA and DHA be provided by dietary supplements. Effective dosages of EPA and DHA for the treatment of hypertriglyceridemia should be un-dertaken only under a physician’s care.