I am long but not a Doctor. What is better about Vacepa? PLUSEPA SAYS IT IS PURE EPA AND NO DHA?? I am long so this is important to me to know.
Sentiment: Strong Buy
This is a very good question! I can see there are confusions among people. PlusEPA is a dietary supplement (DS) whereas Vascepa is a prescription drug (Rx). The key differentiators are the regulatory requirements for taking these two types of products to market.
For DS, FDA does NOT require clinical trials in human to prove safety and efficacy. In fact, efficacy is not even considered by FDA. The agency only requires the DS ingredient manufacturers to SELF declare safety, and the animal safety data together with some historical toxicology information of similar/related ingredient in human are sufficient to declare product safety. For instance, human has been eating grapes for ages with no harm, so ingredient extracted from grapeseed is safe. DS manufacturers typically conduct toxicity studies using rats or mice to generate safety data specific to the product. Once they collect all the information, they will file the self declaration to FDA to get a notification from the agency which allows them to put the product on the market. The process is called NDIN, new dietary ingredient notification. As you can see, there is minimal to no data from human trial, and efficacy is not demonstrated (and required) at all.
For Rx, FDA requires at clinical trials in three phases. These are trials in human subjects typically patients with the disease of the Rx candidate's targeted therapeutic indication. Phase 1 - 2 trials are solely for evaluating the safety of the Rx candidate, and Phase 3 trials are focusing on efficacy. Many cases, Phase 4 trial is required for post market monitoring. In addition, the clinical trial protocols need to be reviewed and approved by FDA. So all Rx products have gone through thorough testing in human before they are approved for US market launch. Their safety and efficacy profiles are fairly well understood. Therefore physicians are well informed with the pros and cons of the products. They also feel more confident and comfortable of using or not using the Rx products. The clinical trial data are considered valuable asset in financial world. Therefore Rx product is valued much higher than DS product.
Those are from the regulatory point of views. From scientific point of view, taking DS products especially those natural extracts for long-term can have substantial hidden risk. The composition stated on the label is just the substances that scientific, analytical instrument is able to detect. In fact there are tons of other substances present but at minute level that is below analytical instrument detection level. So they are not put into the label. For instance, I was told by a couple analytical chemists that some natural DS ingredients can fluoresce in dark, not that the natural fluorescent dye is toxic but it indicates that there are things present that we don't know. So if you take those products day in and day out, it's possible that these minute amount of things can't be excreted completely and are gradually accumulated in your body to a level that they can do whatever they are supposed to do to your body.
I talked to a GNC store rep. yesterday-9/1/2012.She had 6 bottles in "Dicontinued aisle". They had dropped the price from 29$ to 13$ per bottle of 36 pills. One pill has 500mg.of EPA.
She said-we won't be carrying it.
Then I went to another store at the Mall--They did not carry it either.
There is some reason for discontinuing it.--I did not buy it--because of recent visit to Walmart store to buy Tylenol. Pharm.told me that it was RECALLED.
Guess what-we were taking it without knowing that we should stop and return it.Any how hope 46 pills--500mg Gels won't do much harm.
You raised a very important pt. There has been much concern over the years with PCB contamination in a lot of OTC fish oil .
GNC. Seems to have it's own problems with recalls ...
I take Minami Nutrition PLUSEPA ....I get it thru Amazon ....costs about 60 c per 500mg capsule so I spend about $3.60 a day on it ( 3gms ) and it gets my TG's from over 200 down to 102.
I'll look for recalls of Minami Nutrition's EPA .......good argument for going with the Rx version ( Vascepa )
Thanks for the info .
Plusepa in addition to pure EPA contains: 27 mg of other Omega-3s.
While these omegas may be safe, they have not been thru FDA phase testing.
We do not know the effects of small changes in the formula unless it goes thru testing.
Otherwise drug companies would change their formula claiming they only made minor changes from the approved drug.
Plusepa and Vescepa are not totally the same.
Insurance co-pay and FDA approval. PLUSEPA is about $5.28 for 4 Gram dose, you have 7.5 day supply in each 60 cap bottle.
Vascepa, an FDA approved product, it will most likely sell for $7+ for a 4 Gram dose. Why more, well Amarin spent $100's of millions of dollars and now is the ONLY FDA approved EPA source drug out...guaranteed 96% pure and directed use by a medical doctor.
If you want to pay $2000 out of pocket per year for PLUSEPA and treat your own 500 triglyceride level, then your smart enough to have a job with insurance and a physician. If you don't have insurance or basic medical care, then I argue you have bigger problems than your triglyceride levels. ***not cutting on anyone who doesn't have insurance or access to medical care, just stating the facts***
Sentiment: Strong Buy
Well Carrix is partly correct .
PLUSEPA is similar to Vascepa ---not the same
No doctor wants you taking it at 4gm strength----- if you want 4 gm strength then you need a doctors prescription , blood work and a careful look at the other meds you may be on -- particularly blood thinners.
If you were only taking it at 2 gm strength then there's probably not much difference between PLUSEPA and Vascepa ------ but if they are going to end up costing you much the same ( Vascepa at tier 2 co pay ) why not go with the Rx quality.
I'm currently taking 3 gms of PLUSEPA a day --- it has cut my TG's in half. I would like to go to 4 gms but my primary care doctor , my wife ( a P A ) and my friend/client a Cardiologist have all insisted I don't do that until Vascepa is available.
PLUSEPA must be different than Vascepa in enough ways to not be in violation of the AMRN patents once they are issued. It's likely similar but without detailed trials I can't see anyone choosing it OVER Vascepa once it is available. FDA approval makes 1 an approved, regulated drug and the other one a non- regulated supplement, that in itself is enough difference.
Carrix and Akanz thanks
My ENT told me to take an OTC antihistamine so I wondered if a Cardiologist might do the same with PlusEpa, but if they are the same cost approximately, then of course with a dietary supplement you don't know what the purity really is and they don't answer to FDA.
Your point on blood work is good also, as I didn't need to get blood work for the antihistamine recommendation.
Sound like if you just take PlusEpa and decide to double your dose not under doctor care there could be some health ramifications.
I do wonder how Amarin got a patent if PlusEpa already existed in public domain.
I own a ton of Amarin and have a chunk of cash ready in case the NCE is not approved to buy more.
Sentiment: Strong Buy
Yes, PlusEPA is pretty much the same thing as Vascepa. The difference is that Vascepa is FDA approved prescription drug, while PlusEPA is a dietary supplement. So doctors will only prescribe Vascepa. But if you simply want to get the benefit of Vascepa and aren't sick enough to warrant a doctor's care, then by all means, PlusEPA will give you the same benefit.
Hope this helps.