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Amarin Corporation plc Message Board

ganj1948 10 posts  |  Last Activity: Sep 16, 2014 2:47 PM Member since: Jul 14, 2013
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  • This was posted on Investor Village yesterday from Table 13 of the guidelines

    "For fibric acids and long-chain omega-3 fatty acid drugs, LDL-C

    may increase in patients with very high TG, except for omega-3 products

    that contain eicosapentaenoic acid only, and no docosahexaenoic

    acid."

    In other words they are saying that fibrates and Lovaza type Omega-3 products can increase the bad LDL-C while Vascepa (EPA only) does not. A possible Vascepa label expansion could just be this quote and the other direct quote from the guidelines about Jelis and other studies suggesting that reducing trigs also reduces CV events. If it is published by the National Lipid Association in its treatment guidelines-how could the FDA object?

  • Part of the report is very favorable to Vascepa. "If maximum
    tolerated statin therapy does not lower
    non-HDL-C below goal levels in patients with triglycerides
    200 to 499 mg/dL, adding an agent that primarily lowers
    triglycerides and VLDL-C may help to achieve atherogenic
    cholesterol goals. Subgroup analyses from cardiovascular
    outcomes studies provide suggestive evidence of reduced
    ASCVD event risk with the addition of a triglyceride lowering
    agent to statin therapy, particularly in patients
    with the combination of elevated triglycerides and low
    HDL-C." One of the 3 studies referenced is the Jelis Study.

  • "The NLA’s main focus is providing resources for clinical practice and education, and generating awareness around lipid management for our membership. To support this initiative, the NLA will be releasing clinical recommendations mid-September on a patient-centered approach to managing dyslipidemia."
    This could be huge. I remember that everyone was disappointed when the American Heart Association Guidelines were statins, statins and more statins. The NLA will most likely come out with recommendations pushing omega 3 products (and warning against Niacin use). See the second half of the yesterday's posting by g550drvr titled "Great Read!" for more detail. These recommendations plus any new FDA changes could provide a big push to Amarin's PPS.

  • Reply to

    Great read!

    by g550drvr Sep 3, 2014 7:52 AM
    ganj1948 ganj1948 Sep 3, 2014 4:22 PM Flag

    It will be interesting to see if their clinical recommendations include mention of Vascepa. I hope that the FDA takes these recommendations seriously in reconsidering their Adcom position that triglycerides are not important.

  • ganj1948 ganj1948 Aug 20, 2014 10:42 AM Flag

    This one line from the study shows how with proper education of doctors, Vascepa could blow Lovaza up-"However, clinical studies have reported that lower levels of EPA, but not DHA, were significantly associated with all-cause mortality [23], and that there was no clear association between the DHA/AA ratio and cardiovascular risk [24]."

  • The HPS2 THRIVE study has these questions and answers posted on its website:

    Should people take ER niacin/laropiprant now the study is over?

    No. HPS2-THRIVE showed that ER niacin/laropiprant does not reduce the risk of heart attacks and strokes and furthermore it does increase the risk of side effects. Because of the HPS2-THRIVE results, the manufacturer of ER niacin/laropiprant (Merck Sharp & Dohme) have decided to cease making the drug and have suspended it from the market.

    Should people take niacin alone in the light of the HPS2-THRIVE results?

    Probably not. The similarity between the results of HPS2-THRIVE and previous smaller studies which tested niacin (without laropiprant) means that it is very unlikely that niacin is beneficial. Whether niacin alone causes the same side effects as ER niacin/laropiprant (in particular, the unexpected side effects of bleeding and infection) is less clear and the results of previous studies are being explored to investigate this. People currently taking other ER niacin preparations should discuss these findings with their own doctor.

  • nlaresourcecenter.lipidjournal.c**/Home/SponsoredQandA

  • Reply to

    EPADI PRESS RELEASE

    by koleminer1 Jun 25, 2014 11:49 AM
    ganj1948 ganj1948 Jun 25, 2014 11:56 AM Flag

    This is a must read press release. Thanks again to EPADI for doing a fantastic job.

  • Beatrice Golomb, MD, PhD, of the University of California San Diego, who wrote an accompanying editorial, told MedPage Today that the findings "should not change recommendations in people who are in categories that clearly show net benefit for the patient -- [as] gauged by benefit to all-cause mortality -- like middle-aged men with heart disease ... who on average clearly show mortality benefit from statins."

    "But they might actually moderate enthusiasm for prescribing statins in other groups, where, on average, all-cause mortality has been neutral and all-cause serious adverse effects have been neutral ...," she said.
    http://www.medpagetoday.com/Cardiology/Dyslipidemia/46237

  • Reply to

    Vascepa's ApoC-III data helps, too

    by cmm3rd Jun 21, 2014 2:10 AM
    ganj1948 ganj1948 Jun 22, 2014 10:20 AM Flag

    The fibrate and niacin studies showed that lowering triglycerides in patients with normal triglyceride levels to begin with did not help CVD. This is to be expected. However, in those same studies the subgroup analysis of those with high triglyceride levels showed a marked decrease in CVD. This newly published study reinforces that fact and the FDA will hopefully reinstate the SPA based on all the new info.

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