Amarin Corp Plc (AMRN)

[MedResCollab]

High-EPA dietary supplements that can be purchased without a prescription (very convenient) are better than Vascepa in multiple ways. And if 4 g/d Vascepa, or the end result of taking this supplement, which is a sharp increase in serum EPA levels, can reduce the risk of ASCVD, then this advice may harm at-risk patients:

I would encourage those of you who have family and friends who feel V is cost prohibitive to suggest they cut their costs by 25-50% by taking 2 or 3 pills/day instead of 4.

Sure RI was only 4 gms/day, but JELIS was only 1.8 gms (although in a lower risk population). Certainly 2-3 gms is better than 0 gms and we really don't know what the upper limit of efficacy is since only a 4 gm dose was used. -bfost

JELIS enrolled all of its subjects in the late 1990's (suboptimal SOC compared with today), 70% were women, and all were initially placed on very low dose statins (i.e. 5 mg/d simvastatin). 27% discontinued statin use during the study. It was also open label, with the only significant individual endpoint affected being unstable angina. And if strokes were added to the primary composite endpoint (only then making the MCE endpoint comparable with REDUCE-IT), the study would have failed with an 11.5% RRR. Strokes actually trended worse for EPA group in JELIS.

If you are hanging your hat on JELIS, and thus recommended 2 g/d, and you think REDUCE-IT results were barely at all confounded (so that nearly all of the 28% risk reduction in strokes is accurate, etc.), then you are harming those you advise, because 4 g/d may reduce strokes appreciably while 2 g/d evidently does not (per JELIS). One could carry that logic forward with other endpoints as well, as none of the individual components of the composite MCE endpoint in JELIS were significantly reduced except angina.

What would be far better advice that allows a patient to get high EPA blood serum levels (the entire goal of taking Vascepa) while also being able to actually afford the benefit? Answer: Purchasing OTC high-EPA products with third party CoAs, showing exceptional purity and accuracy of labeled quantity of EPA per dose. Also, choosing an ethyl ester EPA supplement (such as Vascepa) is subpar to other forms that have consistently shown to be better absorbed, especially when taken with a lower fat meal or with polypharmacy in evening before sleep (as many patients in a real-world setting do). For example, the very popular rTG form:



OmegaVia and Nordic Naturals exclusively produce this more modern form. In fact, these companies' products may very well be higher purity than Vascepa, as the USP-NF holds pharma companies to lower standards of TOTOX than IFOS and GOED; USP-NF allows peroxide value of up to 10 mEq/kg and p-anisidine of up to 25. Meanwhile, IFOS and GOED have these set at 5 and 20 respectively. OmegaVia (and Nordic Naturals) is well below IFOS threshold.








OmegaVia also conducts routine CoAs to ensure every batch is of very high quality:




OmegaVia is thus better absorbed than Vascepa when taken with or without food; is not dependent upon a high fat meal for absorption (as is Vascepa); and is subject to higher purity and toxicity standards than Vascepa.

Not to mention Vascepa, being a fatty acid ethyl ester, may lead to liver and other organ damage from long-term use:

https://www.jmmc-online.com/article/S0022-2828(98)90812-4/pdf

http://www.jbc.org/content/265/17/9688.full.pdf

Also see pages 55 - 66 in our citizen petition here:

http://www.jbc.org/content/265/17/9688.full.pdf

Re-esterified triglyceride forms are thus a far better choice on multiple fronts. And highly affordable:





And if one is worried about whether the dietary supplement sector can handle the demand, they seem to be doing just fine, even at the near peak of Lovaza sales:



So there you have it. Buy high EPA supplements with third-party CoAs. Probably higher purity than Vascepa, of better absorbed forms (rTG, etc.), and you can avoid ethyl ester forms that may over many years lead to organ damage. Then you can recommend the dose actually studied in REDUCE-IT, and not a dose contrived from a faulty interpretation of an older, irrelevant study (JELIS).

Regards,
-MRC Team