Special OTC Feature: Are over-the-counter Omega-3 products as effective as Lovaza®?

Lovaza® in comparison to some of the other OTC products is more potent in that it contains more of the essential omega-3 fatty acids, EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). These two omega-3 fatty acids are very important in cardiovascular health because they help to regulate cell activity and help support healthy heart function. Lovaza® incorporates approximately 465mg of eicosapentaenoic acid, and approximately 375mg of docosahexaenoic acid into a one gram softgel capsule in the form of ethyl esters. The usual dose of Lovaza® for helping to reduce triglyceride levels is two (2) to four (4) capsules per day with or without a meal for a total of two to four grams per day. The medication can be taken as four capsules at one time, or can be taken as two capsules twice a day. In clinical trials, Lovaza® did show a decrease in triglyceride levels from baseline to study end. In a 16 week prospective, double-blinded, placebo controlled study conducted by Harris et al., consisting of subjects whose triglycerides were between 500 and 2000 mg/dL; Lovaza® decreased triglycerides in forty-two (42) subjects 44.9% from the baseline value of 816 mg/dL. Lovaza® also raised HDL 13% from the baseline value of 22 mg/dL, however, Lovaza® also increased LDL cholesterol 31% from a baseline value of 89 mg/dL. In the placebo group which consisted of forty-two subjects, placebo had no effect on any of the aforementioned parameters. The most common side effects experienced with Lovaza® included eructation (belching), upset stomach, and a fishy aftertaste. 

Using OTC omega-3 fish oil products in place of prescription Lovaza® is another option in helping to cut the cost of the prescription medication. The question that must be asked is whether these over-the-counter products are as effective as the prescription medication? First of all, OTC omega-3 products are not regulated by the Food and Drug Administration (FDA) for safety and efficacy as is Lovaza®. Some products do bear the insignia of the United States Pharmacopeia (USP) on their label. OTC omega-3 products that have this seal printed on the bottle means that the manufacturer of the product has voluntarily met USP standards, thus their product is USP verified. Also, manufacturer's products bearing this seal ensure that: 1) what is on the label is in fact in the bottle (all listed ingredients in the declared amounts); 2) the supplement does not contain harmful levels of contaminants; 3) the supplement will break down and release ingredients in the body; and 4) the supplement has been made under current good manufacturing processes (CGMP). So, before purchasing any OTC supplement product, it is a good idea to see that you are choosing one of the products with the USP sign on the label as opposed to another manufacturer brand not bearing the symbol.

In a 16 week randomized open-label trial conducted by Wohl et al., 52 subjects were enrolled who had fasting triglyceride levels above 200 mg/dL. Twenty-six (26) subjects were assigned to fish oil therapy and 26 assigned to diet and exercise counseling.  Those taking fish oil supplements (3 grams/day) had decreased triglyceride levels and total cholesterol levels from baseline to study end (461 mg/dL to 304 mg/dL and 27 mg/dL to 218 mg/dL respectively). LDL cholesterol increased from 110 mg/dL to 136 mg/dL and HDL cholesterol had no change. Subjects in the diet and exercise arm had increases in triglyceride levels (502 mg/dL to 513 mg/dL), LDL cholesterol (116 mg/dL to 131 mg/dL), and total cholesterol (254 mg/dL to 259 mg/dL). HDL cholesterol decreased (43 mg/dL to 42 mg/dL) from baseline to study end. Results of the trial were statistically significant, and significance was determined by use of 95% CI (see Chart 1). 

OTC products of omega-3 fish oils do contain both eicosapentaenoic acid as well as docosahexaenoic acid, but not in as potent quantities as Lovaza®. A few OTC products that have been USP verified include Berkley & Jensen Fish Oil 1000mg with Omega-3 Fatty Acids, Kirkland Signature Fish Oil Concentrate 1000mg, and Nature Made Fish Oil Extra Strength. These products contain EPA/DHA in the amounts of 180mg/120mg for Berkley & Jensen, 180mg/120mg for Kirkland Signature, and 180mg/144mg for Nature Made respectively. Lovaza® contains 465mg/375mg approximately of these omega-3 fatty acids, thus potency is higher with the prescription medication. All three products retail between $9 and $12 for a bottle of one to three hundred gelcaps, which is significantly less expensive than Lovaza®. The amount of gelcaps taken per day ranges from six to twelve for reducing triglyceride levels. This differs tremendously from just 4 softgels daily for Lovaza®. The same side effects as Lovaza® are present including belching, fishy aftertaste, and upset stomach. 

In conclusion, I believe that OTC omega-3 products do offer an alternative to the higher priced Lovaza®. Although it is not known the exact percentages that triglyceride levels would be lowered with each product, there is evidence to support use of EPA and DHA for maintaining a healthy heart and lifestyle. Due to this, I would like to see a head to head comparison study of Lovaza® and OTC omega-3 fish oils to determine the true efficacy of these medications. If the compliance issue of taking six to twelve pills per day can be managed, then the use of omega-3 OTC products could be a viable option as well as a substantial monetary savings.