Steven Nissen, MD, Chief Cardiologist and Chief Academic Officer of the Heart, Vascular and Thoracic Institute at the Cleveland Clinic talks about how a clinic-led trial finds high doses of prescription fish oil does not reduce major cardiac events in high-risk patients and increases the risk of atrial fibrillation.
Tell me what you were looking for in the strength trial and what the results showed?
Dr. Nissen: The strength trial is an exceptionally large clinical trial. It was performed at over 600 sites and in 20 plus countries. The question was could we reduce the risk of major cardiovascular events by administering a modified fish oil. This is a drug that is like the fish oil people buy over the counter but much more effective. It has a higher amount of omega three fatty acids, which is the active component in fish oil, and we gave patients four capsules a day. The placebo was corn oil, the common oil people use to cook. What we found is there was absolutely no reduction in cardiovascular events using this highly active fish oil. The study was essentially neutral with no difference in the outcome between the two groups. Now, this is important because an earlier trial had compared another fish oil product and used mineral oil as the comparator, and we make the case in this presentation and in this scientific manuscript that the most likely reason that earlier trial was favorable was it compared the fish oil product to a placebo that was actually harmful. So, it was not that the drug was beneficial, it was that the placebo was harmful. This is a very provocative study. The earlier drug that was favorable that is being widely marketed, got approved by the FDA, but we think it is a mistake and we think the fish oil is not particularly beneficial. Most importantly, in patients treated with the fish oil product, there was a 69% higher risk of atrial fibrillation, so there is some harm associated with taking the fish oil and that is an important finding.
So where do we go from here with the research?
Dr. Nissen: The Food and Drug Administration is going to have to look at these results and consider them in the context of their favorable action with another fish oil product. We need to take an awfully close look because perhaps we have headed down the wrong path. It is a particularly important scientific lesson. It is important to understand when you look at an active drug in a trial, what it was compared with. If it was being compared with a neutral placebo, something that does not do anything and the results are favorable, you can believe those results. The problem is what happens when the drug you compared to is active itself and harmful. So, it is an important scientific lesson. This study is going to be widely discussed in the scientific community, but it is also important for the public because people believe that fish oil is beneficial. We do not have any evidence that it is. We have some evidence that there is harm associated with it. Now, keep in mind that most people who take over the counter fish oils are taking a smaller dose. But nonetheless, we think it is important that anything that people are taking needs to be studied carefully in a rigorous clinical trial before it is widely used. I am concerned that fish oil is being used widely without particularly good evidence of the benefits, and I think we are going to have to come to terms with that problem.
Prescription dose fish oil is not the type of fish oil that you go to the drugstore and pick up over the counter, right?
Dr. Nissen: Correct, it is prescription-strength fish oil. Keep in mind that it is four capsules a day, but it contains a lot more active ingredients than you would get from an over-the-counter fish oil product. So, it is really apples and oranges. The fish oil products that most people take, only a small amount of the fish oil in the capsules is active ingredients, which is the omega three fatty acid. So, it is really a vastly different product.
This would be something your doctor would prescribe to you.
Dr. Nissen: This is a prescription fish oil. The people we enrolled in the trial have had high levels of triglycerides and low levels of good HDL cholesterol. So, it was not just everybody, but a specific group of people that we and everybody thought had the highest likelihood of showing benefits. It is widely believed that fish oils are beneficial, and it is really a wakeup call when you see a study where the most potent prescription-grade fish oil did not have any favorable effects. It certainly does not suggest that over-the-counter fish oil is something that should be widely consumed.
What would your take-home message be based on the study?
Dr. Nissen: An extremely high dose of an immensely powerful fish oil did not produce any reduction in the risk of heart attack, stroke, or death. That was the important finding from the trial, that fish oil simply does not produce a cardiovascular benefit.
Is there anything else you think is important to mention about the study?
Dr. Nissen: This thing is going to light up the Twitter sphere. I mean, people are going to go nuts because the FDA gave an extremely aggressive label to this other product based upon a trial that we believe was flawed. I am going to be out there talking about it very aggressively. I have had interviews with the New York Times, Washington Post, Wall Street Journal, and CBS News. So, do not be surprised if this gets a lot of attention.
Interview conducted by Ivanhoe Broadcast News.
END OF INTERVIEW
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