REDUCE-IT reduced MACE by 25%, does it validate Vascepa?

The American Heart Association (AHA) Scientific Sessions November 10-12th in Chicago will have great science as always, but may stand out as having the most significant impact on cholesterol management, exercise as a drug with specific guidelines, results from novel medicines and important practice implications of any AHA meeting in the last decade. 

In AHA meetings, Late Breaking Scientific Sessions stand out as having crucial results, potential practice changing results and often see new treatments come of age in a single presentation. One such session will happen November 10, 2018 at about 2:16 PM. THis editor will be there to get the information and is excited at the potential value of icosapent ethyl (EPA), also known as Vascepa, more commonly known as fish oil and reported in lay press as "prescription fish oil".

Fish oil containing DHA and EPA had negative results in some recent studies, however the REDUCT-IT study (NCT 01492361) revealed a 25 % relative risk reduction in Major Cardiac Events. This study evaluated Vacepa, an EPA only fish oil in a dose of 4 grams a day in a large number of people (8,175) who had high triglycerides (150-499 mg/dl) despite taking statins. This study was important for many reasons:

1) The study was large, well designed and multinational.

2) The drug was well-tolerated in the study which started in 2011.

3) The results are remarkable in that a 25 % lowering of heart and blood vessel (cardiovascular) events was seen.

4) The study of Vascepa (EPA) will be fully discussed at a major conference in a late breaking clinical session.

5) The results of REDUCE-IT certainly have the probability of changing FDA approved labeling for Vascepa and probably will  significantly help a large number of patients avoid serious heart-related problems.

Vascepa has had a limited treatment approval for addressing high triglycerides, but now appears to have a much much more significant effect. Will prescription fish oil come of age November 10th. It appears most probably so and an unmet medical need for a large number of heart patients may be filled  by Vascepa in combination with other evidence-based treatments.

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