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Remember This: Omacor Carotid Endarterectomy Intervention (OCEAN) Study?

|Includes: Amarin Corporation PLC (AMRN)

Omacor is the prior name of Lovaza before Reliant had to change it because of the similarity to Amicar.

Lovaza details:

Each 1-gram capsule of Lovaza contains at least 900 mg of the ethyl esters of omega-3 fatty acids sourced from fish oils. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).

Anyhow, the OCEAN trial:

"was set up to provide evidence that omega-3 fatty acids enter carotid plaques and induce changes indicative of increased plaque stability and that they reduce the expression of inflammatory mediators in the plaque."

So, their goal was to try to follow up the success of the GISSI trial in order to provide evidence that Omega-3s (2 grams a day of Omacor/Lovaza - 930mg EPA 750mg DHA) actually changes the morphology of atherosclerotic plaques, let's look at the design and the results:

"Presenting the OCEAN findings, Calder said that patients identified for carotid endarterectomy were randomized to treatment with 2 g/day of omega-3 fatty acids or placebo. Patients remained in the trial until surgery, which, historically, was an average of 40 to 50 days after first being identified for endarterectomy. After surgery, the investigators obtained the plaque and studied the morphology, histology, and cellular infiltration using immunohistochemistry, as well as the expression of MMPs, cytokines, and adhesion molecules at the mRNA level.

In total, 112 patients were randomized to therapy, with 50 patients in the placebo arm and 45 patients in the active-therapy arm completing the study. Average patient age was 75 years and a majority were men. Patients were typically overweight and former or current smokers and had hypertension. Calder noted that lipid measurements were typically good, likely because patients were well treated, with 85% taking statins and 80% taking aspirin.

Investigators report that EPA and DHA were rapidly taken up into the plaque. There was a significant 100% increase in EPA content in the plaque in patients supplemented with omega-3 fatty acids, but only a 10% nonsignificant increase in the uptake of DHA in the atherosclerotic plaque. The number of foam cells was significantly lower in those treated with fatty acids vs those randomized to placebo.

Calder noted that a combined mean score, a composite summed measure that includes the size of the lipid core, number of foam cells, and number of macrophages in the plaque and the cap, as well as the overall density of inflammation in the plaque and cap, was lower among patients treated with omega-3 fatty acids. The mean score was significantly negatively correlated with plaque EPA, he reported.

"In other words, the more EPA in the plaque, the less inflamed and more stable it is," said Calder.

In addition, investigators measured mRNA levels for seven MMPs. Three of the seven-MMP-9, MMP-7, and MMP-12-were significantly decreased in patients supplemented with omega-3 fatty acids. Intercellular adhesion molecule 1 (ICAM-1), an adhesion molecule involved in the recruitment of monocytes into the vessel wall, and the inflammatory cytokine interleukin-6 were also lower in patients taking fatty acids."

So, this trial using Lovaza reveals that EPA is crucial for stabilizing plaques. "The more EPA in the plaque, the less inflamed and more stable it is." And this is using 930mg per day. Vascepa is 4,000mg per day...

Does this sound beneficial to you, especially if you remove the DHA that raises LDL-C?

Disclosure: I am long AMRN.