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ESC TV at AHA 2018 – REDUCE-IT Trial

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Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial.

So the reducer trial was a large randomized trial in approximately 8,000 patients with either secondary prevention or high-risk primary prevention all patients on statins and all patients with elevated triglycerides equal to or above 135 but less than 500 and it tested epa a a purified formulation of omega-3 fatty acids aiko’s at penta and hill for the prevention

Of cardiovascular events long-term now what is particularly in this trial a number of features are specific to this trial first of all we used a high dose of epa for grounds far more than has been used in the past in the many previous trials of omega-3 fatty acids and twice as much or a little more than twice as much as was used in the jealous japanese trial the

Second feature is the patient’s all had elevated triglycerides now with follow-up what we found was an if this was largely unexpected truly we found a 25% reduction in the primary composite outcome of cardiovascular events and when we look at the key secondary outcome of cvd smi and stroke which is the conventional heart outcome used by most cardiology trial it

Was also a 25% reduction in addition there was a 20% reduction in cardiovascular mortality so these are major treatment effects associated with highly statistically significant and associated with very low numbers needed to treat and large absolute reductions in high-risk populations now in terms of safety the drug was reasonably safe there was a statistically

Significant increase in the incidence of atrial fibrillation or atrial flutter by approximately 2% there was a borderline increase in bleeding and we know that omega-3 fatty acids are associated with decreased viscosity and potential platelet effects and there were some modest differences in other side effects of lesser importance so the overall result is a dramatic

Reduction in cardiovascular events for a treatment that has a potential to really be widely used in practice because it’s not very expensive it’s reasonably easy to use and to take and i would like to point out that this is this is a surprise because recently there was a meta-analysis that looked at all of the trials of mega 3 fatty acids and most of the trials

Have been negative however most of the trials were done in low-risk patient population at much lower doses not with the purified epa that were used in this trial the only exception to that rule was the japanese jealous trial which actually was positive and found a 19% reduction not inconsistent with our own findings so there are two trials at high doses of omega-3

Fatty acids with fairly similar preparations that were positive and the rest of the trials used one gram or less of non purified preparations and were negative so i think we have some understanding that maybe dose might be critical a couple of other comments triglycerides we selected proposal ii patients with elevated triglycerides but in the end it doesn’t seem

To matter because when we look at the treatment effect as a function of baseline triglycerides the results are the same and there’s neither any interaction with achieve triglyceride levels after a year doesn’t seem to impact results so it’s probably not about triglycerides and actually it raises the question of how does this work and to be really fair we don’t

Really know there are myriad hypotheses about benefits of omega-3 fatty acids and with the current data we have at this stage we’re not fully sure of how it works but what it’s clear that there is unambiguous cardiovascular benefit

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ESC TV at AHA 2018 – REDUCE-IT Trial By European Society of Cardiology