Vascepa is entirely EPA ethyl esters, a derivative of one of the EPA omega-3 fatty acids found in fish oil. Fish oil is very distinct from purified EPA ethyl esters. Fish oil fatty acids are primarily in triglyceride chemical form with some contribution from phospholipids too; Vascepa is in ethyl ester form. Fish oil contains a mix of fatty acids including saturated fatty acids, monounsaturated fatty acids, omega-6 polyunsaturated fatty acids, and both EPA and DHA omega-3 fatty acids. Many of these other fatty acids may have harmful effect. For example saturated fatty acids are well documented to raise LDL-C and there is growing evidence that DHA but not EPA also has a LDL-C raising effect. There is no other product on the market or in trials other than Vascepa that is only purified EPA. The STRENGTH trial that reads out next year is a CVOT looking at a purified mix of EPA and DHA at the same 4g/day as Vascepa in REDUCE-IT and STRENGTH is using much wiser corn oil placebo instead of mineral oil. So maybe competition but depends on STRENGTH trial results.

NNT for Vascepa was 28 for 3-point MACE over 4.9 years. That's pretty good! For now, it will likely only be approved for patients with elevated triglycerides, which is a big pool. Obesity, insulin resistance, diabetes, fatty liver....these all prevalent in our society and contribute to elevated triglycerides. It will be interesting to see what is agreed upon between Amarin and the FDA next year for product labeling related to MACE. Not too surprising that your insurance wouldn't cover it for you without having elevated triglycerides. But there will be a lot of patients at risk for CVD whose docs may still prescribe for off label use in patients without elevated triglycerides.

Apabetalone may have it's own struggles out of the gate after BETonMACE. It might achieve an outstanding NNT for its patient population, but BETonMACE is a very narrow patient population (diabetes, low HDL, recent ACS within 90 days). I imagine the initial product label may be for a narrow population. But with further clinical trials in expanded populations, Vascepa and apabetalone may prove themselves in the future for expanded populations and indications. But until then, off label use would be an alternative at the discretion of the prescribing doctor. And just as your insurance wouldn't cover Vascepa for off label patients/indications, expect the same issue for apabetalone. What further complicates apabetalone is not having it approved already for modifying a risk factor like Vascepa already has for triglycerides prior to REDUCE-IT. We'll have to wait for BETonMACE results to find out what secondary endpoints may have been modified that may be used as a marker of drug efficacy (HDL-C, apo-AI, glucose, hsCRP, ALP,  etc).

These are all secondary concerns. First up, nail that primary endpoint in BETonMACE!

BearDownAZ