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Amarin Corporation plc Message Board

  • mtdsus mtdsus Feb 5, 2013 11:47 AM Flag

    Kay,Can you find out C-rp median of Reduce-IT study enrolled group?

    Kay,
    More researchers in Japan are reanalyzing JELIS data and finding that inflammation was a key factor in JELIS good results.I have seen 2 articles in 2011 and 2012.One was sent to me by Dr.Barry Sears.
    What is the median C-RP of Reduce-IT study participants? Can you find out?

    Sentiment: Buy

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    • Mtdsus
      Heard back re HsCRP " will only be analyzed at the very end of the trial and is not a specific endpoint in this case "
      I have a blood test coming up in about 2 weeks . If I get my LDL down close to 100 with max dose Crestor and max dose Zetia --- I'll re apply for the Reduce it Trial . It seems a hard trial to get into -very strict requirements --- so lets hope they meet their 40% enrollment by the end of Feb --which I believe was their aim .

      AK

    • Mtdsus

      Direct from the Reduce it Trial
      1) Aim is to " follow a group who are likely to have an event " ---thus we " choose the higher risk patients --these patients are the most likely to benefit in the short term "

      2) Entry Criteria " Men and women over 45 with either Coronary Artery Disease ( heart attacks , stents , CABG ( bypass ? ) ) and/or diabetes with high blood pressure or some other risk factors such as low HDL "

      3) TG's 135 -500 and
      LDL 70-100 is required ..... Not concerned about which statin you use to get your LDL below 100 or if you also used Zetia with a statin to get LDL below 100.

      Previous email said they place a high emphasis on the patient having diabetes ... ie if you have not had a heart attack but had diabetes and other risk factors you could still qualify.
      No word on Hs CRP yet

      Its a very different trial IMHO then Jelis who seemed to have fairly health folks with slightly elevated LDL cholesterol...... Reduce it wants patients at high risk of "eventing "
      AK

    • Too early to get that baseline data and I believe all of the research companies operate under NDA's but I will look around.

      Sentiment: Strong Buy

    • Mtdsus
      I know some one working on the trial in Nth Ca ---I'll email them for you ---any other questions you want me to ask ?
      AK

      • 1 Reply to akanz2
      • Although my interest is C-RP,pl. try to find out what you can -about other parameters-like
        LDL -C levels,HDL and previous heart ailments.
        We know TG has to be greater than 150mg./dl.--but what is the median TG of all so far.Since this is part of Anchor deal with FDA--Median has to be between 200-500mg--but is the Median 400 or 300 mg?
        Of course-what Statin is being used mostly and its dosage? If most are using Crestor,then that indicates C-rp to be high. Thought--indirect information may give us clues for C-rp levels.
        My point: Are they enrolling people who are at high risk of Heart Attack?
        JELIS did not plan around the risks when selecting patients--but we know that people with TG greater than 150 and HDL less than 40 mg./dl. saw 53% reduction.
        How is Reduce-It selecting their participants?

 
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