A new clinical trial studying a prescription strength specialty fish oil has concluded. The product is Vascepa by Amarin, and it is a unique product. Most fish oil products are a combination of the two essential fatty acids (Omega-3s) EPA and DHA. Vascepa, however, is 100% EPA. The dose studied in the trial was 4000 mg, which is a pretty tall order compared to how most Americans use their fish oil. If you’ve read our other articles about fish oil, you know how hard we rant on about dose of essential fatty acids.
The study itself has yet to be published, but the manufacturer has released topline data. We will update this article when the study becomes available. From what we know, the results are super awesome and speak to a bigger picture of the role of essential fatty acids and health.
All About The Trial
To be in the trial, patients had to have high cholesterol completely managed with a statin. Statin drugs, if you don’t know, are the worst drugs ever made and everyone hates them. In truth, they are medications that lower cholesterol and have shown to decrease heart attack and stroke risk. They, like any drug or supplement, carry liabilities that should definitely be addressed.
To be “managed well” with a statin for the study means that if you go to the doc and she says, “Hey man, chill on the pizza your LDL is 130,” you couldn’t be in the study until you were on a statin and got your number under 100.
Study participants also had at least one other risk factor for heart disease: blood pressure, diabetes, etc.
Then, they separated people into two groups: those treated with 4000mg of EPA and those treated with a placebo. There were over 8000 participants and the study was conducted for almost 5 years. This is excellent, from a quality of data standpoint.
What they were looking for wasn’t how EPA affects cholesterol – that’s pretty well established. We know from past clinical trials that EPA and DHA can help lower triglycerides well. We also know that sometimes cholesterol can go up with people using high dose EPA and DHA. In this study, they found that bad cholesterol did not rise. We now almost conclusively know that DHA can be blamed for that bump. More on this once the analysis is out.
The study, instead, was looking at outcomes. What they were looking for was if the drug therapy actually saved lives. Did people have more or less cardiovascular events like stroke or heart attack? Were people more or less likely to die from those events?
And it seems the drug had a positive effect. Pure EPA dosed at 4000mg daily in people with controlled cholesterol and other CV risks were less likely to have serious cardiovascular events and were less likely to die, compared to similar people who were NOT treated with Vascepa. There’s up to a 25% risk reduction. That’s amazing.
The full data hasn’t been released yet, just the press release and top-line data. It’s a big announcement and everyone’s excited to see the study, which we are expecting in November.
What This Tells Us
This is pretty unique and significant. We don’t have real outcomes data on fish oil. In fact, it always feels the opposite! There are a multitude of trials on fish oil products – prescription and OTCs – where they show no effect or effect on outcomes. This is the first well-constructed study to show such a benefit for essential fatty acids on health.
The data is basically saying that people with heart disease risk who are doing all the things their doctors say who add 4000mg of EPA daily will be healthier and live longer than those who don’t.
It’s important to understand three points here. First, the people were taking statins. This is a big problem for many of our readers, even though we stressed the importance of proper cardiovascular risk management in our Heart Healthy Supplements article. Second, they were taking enough of the statin to get their cholesterol to normal numbers – not just lower than “high.” Some people who are reluctant to take a statin will use low doses and not aggressively manage their numbers. Finally, the fish oil dose was LARGE and the product was used every day.
It also tells us that this $350 per month fish oil will be widely marketed and on TV every 20 minutes.
What This Doesn’t Tell Us
It’s important to know a few very important facts. First, these results impact a very specific group of people. We can’t make assumptions outside of this group of people. Meaning we can’t say EVERYONE NEEDS TO TAKE VASCEPA AND YOU’LL LIVE TO BE 100! We can say adding this drug can have tremendous benefits to these types of patients.
We here can get excited because a high dose fish oil is showing benefit on serious cardiovascular events – something we knew would happen once studies just like this one were done.
Very important: this is showing pure EPA at 4000mg is a successful add-on to traditional therapies, not a replacement for them.
Also, Vascepa is NOT the same as over the counter fish oil. The manufacturer makes that VERY clear, probably because they want to sell their stuff. It is high dose EPA only. Most products will have EPA and DHA. The dose is high if I haven’t mentioned that yet. Most people take nowhere near the studied dose. Dose is something we’ve stressed time and time again.
What we know from large studies that DHA will have a negative impact on cholesterol when taken in high doses – whether that matters, it’s left to be seen..
Until we have clear data, we can’t assume our over-the-counter options are the same. You can’t take 4000mg of fish oil (EPA + DHA) and expect the same results as in this study (EPA alone). Heck, you can’t even take enough fish oil to get 4000mg of EPA only and expect the same results. If it contains DHA, theoretically it is NOT the same.
We also don’t know how 4000 mg of EPA alone affects people with NO cardiovascular risk. Does it decrease chances of getting heart disease? Does it improve survival? Or is it only worth it AFTER your risks start stacking up and you get controlled with traditional methods first?
We don’t know. We can’t assume.
What we CAN do is make smarter decisions when it comes to fish oil supplementation. Here are my updated recommendations:
- EPA and DHA are crucial nutrients that many of us don’t get from our diet. We need at least 3000mg of EPA and DHA each day based on our intake of Omega-6. This goes for even the healthiest plant-based diets – we need more EPA and DHA.
- We can use fish oil as a clean source of EPA and DHA. It is a Vital 5 supplement because of the health benefits and difficulty getting adequate levels from diet alone.
- Use one of our High Potency Fish Oils to achieve a total daily dose of at least 3000mg of EPA and DHA.
If you can’t commit to a daily dose of 3000mg on average (from supplements and diet) for whatever reason – including cost – it’s probably best to NOT use fish oil at all. There is ample evidence to not even bother. Using too low of a dose will not have any benefit, so don’t waste your time and energy if you’re not getting your total of at least 3000mg.
Remember, we can assist you in a meal and nutritional plan . We can do the math to see what amount of EPA and DHA you need to supplement. If you have a very healthy fish-based diet, you may be able to use lower amounts of supplements to get to your goal.
Try to get higher doses of EPA when possible. In the near future, we will be introducing a product that is almost entirely EPA.
The Short Version AKA Our Recommendations On Fish Oil
- No heart disease, high cholesterol, or cardiovascular risk?
- Shoot for 3000mg of EPA and DHA from supplements and diet.
- This includes special populations like vegan/vegetarians, the elderly, and even pregnant or lactating women.
- High cholesterol and other cardiovascular risks?
- BEST: Manage your cholesterol aggressively and consider adding 4000mg of EPA (Vascepa).
- OK: Manage your cholesterol and other risk factors. Use at least 3000mg of EPA and DHA daily to help with triglycerides and support healthy inflammation levels.
- Can’t commit to high potency fish oil? Too much money? Hard to take every day?
- Don’t bother. Daily intake below 3000mg has been shown to be not beneficial, so don’t waste your effort.
- Use these products to get some of the most cost effective, pure fish oil on the market:
Keep The Faith
The results of this study mean a lot to me personally… Storytime!
I went to pharmacy school. Well, I graduated from one but was rarely in attendance, cause I’m a rebel.
We were taught “vitamins are to sell, not to take.” It was a very traditional practitioner education that put little faith in the natural products industry. We looked at the data on supplements and saw how poor it was. We learned about natural product manufacturing and regulations and saw how it was like the wild west.
Like so many before me, I looked to supplements as a mechanism for profit. Early in my pharmacy-ownership, I brought in supplements indiscriminately. No concern for brands, doses, absorption, or quality. It was all BS to me, but BS that had good margins that people bought.
That didn’t last very long. I started to see results in our own customers. We decided to figure out how and why people were benefiting. We wanted to apply the product expertise of a pharmacist to the natural products industry.
I have always asked the tough questions. If someone says they want “red yeast rice”, what is it that they are getting? How should it be dosed? What do they have to be careful of?
When I started asking the tough questions, I saw customers get better. I saw that if I made better decisions about which products I carried, the better the results. There was one supplement class that changed it all for me: fish oil.
Once I understood fish oil from a therapeutic standpoint, I could address quality concerns to deliver the results I knew fish oil could. Essential fatty acids are a crucial nutrient, one that we don’t get nearly enough of.
I’ve been beating the drum about essential fatty acids for a long time. I’ve especially stressed the importance of dose, and placed it a very close second to quality. Study after study, “fish oil doesn’t work” they say. Each time, I said the same thing. Poor quality products. Too low of a dose.
While this study doesn’t prove that healthy people using a well made, high potency fish oil supplement will have those same outcomes, it certainly is validation that I was right.
When you apply standards, rigor, and professional expertise to natural products, the results can be phenomenal.
I have faith that our approach is the right one. Our “middle path” is the right path. Fewer, high quality, properly dosed supplements will win over all the madness – the bad advice and quacks – out there. When the studies are done – when the data comes in – our approach will land on the right side of history.
The Fish Oil Future
This data shows us that essential fatty acids, when dosed correctly, can be tremendously beneficial to people’s health. Vascepa is expensive, but it may be worth it for the right people. If you have the risks – go for it. Don’t look to supplements, get the studied product.
For the rest of us, stay the course. Commit to your essential fatty acids. Take them consistently. Do all your heart-healthy stuff. Keep the faith. Practice wellness with integrity.
Neal Smoller, PharmD
Owner, Pharmacist, Big Mouth