Vascepa is composed of 96% purified EPA (eicosapentaenoic acid), produced to the FDA's strict pharmaceutical standards.
After completing clinical trials in 2011, the FDA approved Vascepa in 2012 for what is called the "Marine" indication, the treatment of very high triglycerides (TG) (> 500 mg/dL). It is estimated that 4 million Americans suffer from very high TGs. Amarin has been marketing Vascepa for the Marine indication since February of this year and since then over 100,000 prescriptions have been written.
In addition to the Marine indication, Amarin had also applied for the "Anchor" indication, the treatment of high TGs in a lower range (between 200 mg/dL and 500 mg/dL) and patients with mixed dyslipidemia who were already on Statin drugs. Mixed dyslipidemia is the condition when two or more lipid markers are out of normal range. This indication addresses a larger population, estimated to be present in 40 million Americans.
In the FDA-approved clinical trials, Vascepa exceeded both the primary and secondary endpoints of the Anchor indication (> 200 mg/dL) with statistical significance. While lowering Triglycerides was the primary endpoint, Vascepa also met and exceeded the secondary endpoints as follows:
- Reduced TGs by 21.5% (p < 0.0001)
- Reduced non‐HDL‐C by 13.6% (p < 0.0001)
- Reduced LDL‐C by 6.2% (demonstrated superiority over statin alone) (p = 0.0067)
- LDL‐C upper confidence boundary ‐1.7%
Vascepa achieved a statistically significantly reduction in pre‐specified Secondary Endpoints:
- Apo B
While EPA is listed on every bottle of fish oil supplements sold by the millions to unsuspecting consumers as being beneficial to cardiovascular (CV) health, it has been clinically proven that small amounts of EPA produces negligible CV benefit. In fact, clinical trials of Vascepa showed that 4 grams of EPA, taken daily, is required to produce therapeutic benefit. If you attempted to match the equivalent 4 grams of EPA using fish oil supplements, it would require, on average, over 20 fish oil capsules taken daily. In doing so, you would not only expose yourself to excessive amounts of bad cholesterol, but other harmful compounds that have been found in unregulated, non-parmaceutical grade products.