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Omega-3: When EPA Makes an Impact
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Omega-3: When EPA Makes an Impact
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Upload Date:
2022-02-28T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
>> Practice Impact Extra podcasts are derived from Hurst's, The Heart Board Review, and other online resources available only through accesscardiology.com. >> There's been a lot of literature written on it. We did something on omega-3 in the past, and there's always been this feeling that there's -- the final nail will go in the coffin. So, it's not exactly clear where omega-3 can fit in or finish.
Hi, Dr. Bernie here, and welcome again to another Practice Impact Extra podcast. The VITAL trial and REDUCE-IT trial were much-anticipated, late-breaking trials at the recent November 2018 American Heart meetings in Chicago. Each trial addressed the question, if higher intake of marine omega-3 fatty acids would be associated with reduced risk of cardiovascular disease in a defined study population.
So, let's begin with VITAL. VITAL is a trial which is a primary cardiovascular prevention trial. It enrolled a large group, 26,000 participants, from an otherwise generally healthy middle-aged population. Inclusion was based on age, men over 50 and women 55 of age or older, and it was really not based on any cardiovascular risk factors. Participants were randomized to 1 gram of omega-3 fatty acid daily and followed for 5.3 years.
The predetermined primary endpoint was major cardiovascular events, that being composite myocardial infarction, stroke, or death from cardiovascular causes. In this large primary prevention trial, the results demonstrated that supplementation with 1 gram of omega-3 fatty acids did not, did not result in a lower instance of major cardiovascular events.
There had been some subanalysis looking at this trial, but as you're aware, subanalysis really -- don't really make a trial, the results when you already have predetermined primary endpoints that were negative, but I thought it was interesting when I looked at the subanalysis finding that there appeared to be a trend toward lower myocardial infarction risk in the omega-3 patient group, and I think that really this generates some hypothesis background for further studies, and I think these are probably warranted, but I don't think they change the predetermined primary endpoint, which again, did not result in -- omega-3 supplementation did not result in a lower incidence of major cardiovascular events.
So, what's my take? I think the study does not support the use of 1 gram of omega-3 for primary prevention of cardiovascular events. Let's take a look at another study that I found to be really a significant impacting practice trial, and that's the REDUCE-IT trial. And this assessed the omega-3 EPA on cardiac outcomes. We know it's been long recognized that despite statin therapy, residual cardiovascular risks persist.
It's also known that triglyceride elevation is an independent risk factor for cardiovascular events. Prior cardiovascular outcomes with lowering-triglyceride agents, such as niacin, fenofibrate, when added to statin did not really impact favorably on the primary endpoints. However, if one takes a look at a Japanese study, it was quite interesting that their omega-3 that they were using did reduce triglycerides.
And more importantly, it resulted in a 53 reduction -- excuse me -- 53% reduction in cardiovascular events in the satin-treated patients. And specifically, this outcome was seen that patients, while on statins, still had a triglyceride level of greater than 150 milligrams per deciliter. The REDUCE-IT trial was designed with the main objective to evaluate whether triglyceride treatment with icosapent 4 grams per day versus placebo would reduce ischemic events in patients at increased cardiovascular risk already being treated with a statin.
This study enrolled 8,000 patients in a blinded randomized placebo method. The primary endpoint was the composite of non-fatal MI, non-fatal stroke, cardiovascular death, revascularization, and unstable angina. The inclusion criteria included statin-treated men and women over the age of 45 years, established cardiovascular disease, 70% of the patients had cardiovascular disease or type 2 diabetes and one additional risk factor, and they all had triglycerides level greater than 150, but less than 500.
These 8,000 patients were followed up over a 5-year period. So, what was the result of this study? Quite interesting and very importantly, there was a 25% reduction in the primary endpoint of non-fatal MI, non-fatal stroke, cardiovascular death, coronary revascularization, and unstable angina, a 25% reduction in that primary endpoint. There was a 26 reduction in the individual secondary endpoint of non-fatal MI, non-fatal stroke, and cardiovascular death.
Indeed, cardiovascular death was reduced by 20% in this study. What about the safety, which is always a major concern? Well, there was a small but absolute 1% increase in atrial fibrillation, but this was unassociated with any embolic stroke. There was also a small increase in bleeding, again unassociated with that being in the CNS system, GI, and was never associated and not associated with fatal events. Some people are trying to postulate, "Well, what are the exact mechanisms for these outcomes?" And I think we can say it's really not clear.
Could it be related to some anti-thrombotic effect or possible plaque stabilization or the antioxidant effect? Because C-reactive protein was reduced. I just don't think that we know what the exact mechanism is. So, what's my take on the REDUCE-IT trial? I think this trial, the REDUCE-IT trial, is strongly evidence-based. The results convincingly show that if you use 4 grams of EPA in patients like those enrolled in this trial, you will lower the risk of adverse cardiac events.
Thank you again for joining me and see you next time on Practice Impact Extra. >> We hope you enjoyed this podcast from McGraw-Hill. Subscribers to AccessCardiology have instant access to over 25,000 pages of rich medical content, receive medical updates from trusted experts, and have access to other special features. To subscribe or learn more, please visit accesscardiology.com.
