bfost, have you ever prescribed a generic before? Did you not realize those generics are not exactly the same as the reference listed drug (RLD), sometimes even using a different carrier of the API altogether? Did you know that generics aren’t required to be tested in outcomes studies, but may rely on the studies of the RLD? Did you know that the active pharmaceutical ingredient (API), and extent of API absorption, especially “not less than 90% of RLD” is all that FDA is concerned with? Did you know the API of Vacsepa is not necessarily ethyl ester EPA, but just EPA? Because it is broken down and absorbed as EPA in serum, and that is the relevance of ethyl ester EPA, to allow EPA to be absorbed? I’m asking because your continued request for outcomes studies for what is in every relevant way generic Vascepa, and a type that actually delivers at least equivalent but most often more API to the patient (and more consistently, not requiring high fat meal for max absorption), shows a lack of understanding in this regard, one that a physician truly ought to possess.
If you are very hard up on the ethyl ester form (which ignores a good deal of reliable data for rTG form), then there are Carlson Labs’ “EPA Gems,” and Minami’s “Plus EPA,” and also HormoneSynergy’s “Synergy Pure EPA,” that all have updated CoAs that show the same exceptional purity as OmegaVia, but are in ethyl ester form.
Advising your patients to take half the dose of REDUCE-IT, when you believe REDUCE-IT, is terrible practice. If you believe REDUCE-IT, you must get them the same levels of API. That should be your goal. Not recommend half-doses of the brand made by a company you are invested in, based on spurious, open-label JELIS data, that showed an equally comparative RRR (with strokes included) of only an insignificant 11.5%.
-MRC
