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Amarin Corporation plc Message Board

  • one_soloist one_soloist Jul 14, 2013 4:49 PM Flag

    "there was no strong evidence that EPA affects mortality one way or another"

    I think we are discovering why the big slide. If you start off believing you have a miracle drug, then it is much harder to come around to the truth. EPA isn't a miracle. It isn't new. It has been prescribed for the last decade all over the world.


    In patients with no history of coronary artery disease, EPA treatment reduced major coronary events by 18%, but this finding was not significant (104 [1·4%] in the EPA group vs 127 [1·7%] in the control group; p=0·132).

    "but this finding was not significant"
    "but this finding was not significant"
    "but this finding was not significant"
    "but this finding was not significant"

    Beatriz L Rodriguez, MD, PhD (University of Hawaii, Honolulu), observed that although the overall reduction in major coronary events in JELIS was an "interesting" result, "there was no strong evidence that EPA affects mortality one way or another."

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    • Soloist
      You state " In patients with no history of coronary artery disease " ---- well the Reduce it Trials is all about patients with coronary artery disease .... you need documented evidence of it to be included in this trial.

      Re Jelis ... the most benefit was seen in the subgroup of high TG's and low HDL ---

      Does EPA ( or fish oils in general ) reduce risk ....suggest you read Current Opinion in the Journal of Lipidology " Omeg-3 fatty acids : mechanisms underlying "protective effects" in atherosclerosis ".

      I think there is a very high likelyhood that Vascepa , in 4 gm daily dose, will show clinical benefit in the Reduce it trial population
      Good to see you posting here again JL

    • soloist...

      Re JELIS

      What you say about JELIS is true, but your conclusions and the AHA person's need some clarification...

      At issue was statistical significance...The JELIS participants were largely middle aged Japanese women with mild cholesterol elevation (on very low doses of statins)..Even though there were over 18,000 patients followed on average over 4 years, very few of them (less than 80) died...The number of deaths was so low that it ruled out any real chance for stat significance,..Actually the results though not mathematically valid did suggest EPA was beneficial..The EPA treated group showed about 20% improvement vs the control in all categories except two, the numbers were even for sudden death?? (a waste basket category, which could include anything from poisoning to suicide) and death from heart attacks in which there were twice as many deaths from AMI in the placebo group. No placebo group beat its EPA rival..

      The study was criticized because of the heavy weighing of the angina group...This was not the study planners fault, but simply a reflection of the fact angina is more common than fatal AMIs...

      ": ) JL

      Sentiment: Strong Buy

    • "one_soloist", you are full of doo-doo. Here's why:

      The Japanese diet is typically healthier than the Western diet. Japanese eat more seafood than we do, and arguably have much higher and consistent plasma levels of EPA/DHA. From the JELIS study: "In all JELIS participants, the risk of major coronary events was significantly decreased (20%) in the group with high (150 µg/mL or more) on-treatment plasma EPA concentration compared with that in the low (less than 87 µg/mL) group."

      The fact that a 1.8 g/day EPA dose reduced coronary events in the Japanese population is incredible. What do you think the 4g/day Vascepa dose will do for mainly Western-diet, REDUCE-IT participants?

      Look for REDUCE-IT results to be more pronounced than JELIS in terms of statistical significance in reduction of coronary events due to: 1) 4g/day dose of Vascepa vs. 1.8g/day EPA in JELIS, and 2) low Omega-3 Western diet.

      Sentiment: Strong Buy

    • The requirement to participate was having at least 117mg/dL of total cholesterol. That was the only pre-req.
      In the sub group that had trigs over 150 and HDL lower than 40, the difference in adverse events was 53%. That is closer to the REDUCE-IT pre-req

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