EMA: Omega 3 fatty acid medicines no longer seen as effective in preventing heart disease

17 Dec 2018 --- The European Medicines Agency (EMA) has concluded that medicines containing omega 3 fatty acids are not effective in preventing further heart and blood vessel problems in patients who have had a heart attack. As a result of this finding, omega 3 fatty acid medicines will no longer be authorized for such use. These types of medicines had been authorized for use after a heart attack at a dose of 1g per day, in combination with other medicines, in several EU countries since 2000.

At the time of their authorization, available data showed some benefits in reducing serious problems with the heart and blood vessels, although the benefits were considered modest. However, EMA reports, more recent data that have become available since then have not confirmed the beneficial effects of these medicines for this use. These medicines can still be used to reduce levels of certain types of blood fat called triglycerides.

Although there are no new safety concerns, the EMA reports that its human medicines committee (CHMP) concluded that the balance between the benefits and risks of omega 3 acid medicines to prevent recurrence of heart disease or stroke is now negative.

Omega 3 fatty acid medicines contain the fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) commonly found in fish oils.

With a sturdy base of scientific backing, innovation in the area of fatty acids is continuous. 

This year, BASF launched Hepaxa in the US as the first-to-market, dedicated product for the dietary management of patients with NAFLD. Hepaxa increases the levels of EPA and DHA in patients with NAFLD, which improves the liver’s ability to process fat.  

In September, Evonik received clearance to market its high-concentration omega 3 lysine powder complex AvailOm for use in the EU. AvailOm is touted as having the highest-load omega 3 powder in its class with a minimum of 45 percent EPA and DHA by weight. In addition to delivering protection against oxidation based upon three years of stability data, it is also directly compressible and can be customized to meet specific formulation requirements.

Supplementing with omega 3 may lower the risk of cognitive depression in people who experience depression and chronic heart failure, a study published in the Journal of the American College of Cardiology’s Heart Failure edition has found. The study found significant correlations between blood levels of EPA plus DHA omega 3s in cognitive, as opposed to somatic, depression among the participants.

The study included 108 subjects who were assigned to one of three groups each taking two grams per day of either a 2:1 mg EPA/DHA supplement, a high EPA product, or a placebo. The study lasted 12 weeks with blood testing (i.e., omega 3 index and RBC levels of EPA and DHA) completed pre- and post-supplementation.

The rsults demonstrated that the omega 3 index reached 7.3 percent in the EPA/DHA group, 7.1 percent in the EPA group and 4.4 percent in the placebo group. This indicates that the dose was adequate to significantly improve the omega 3 index in the space of three months.

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