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Optimer Pharmaceuticals, Inc. (OPTR) Message Board

  • kamoa_1 kamoa_1 Mar 20, 2011 9:12 PM Flag

    Adverse Events...

    Can't help but notice these very important statistics in comparing Fida to Vanco...

    Cardiac Failure
    Fida 4 Vanco 2

    Atrial Fibrilation
    Fida 3 Vanco 1

    Gastrointestinal Hemmorage
    Fida 4 Vanco 1

    Renal Failure
    Fida 4 Vanco 1

    Total very important Adverse Events
    Fida 15 Vanco 5

    Is it safe to conclude that Vanco is three times safer than Fida?
    This can't be real?
    Is it?

    aloha,
    kamoa

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    • Thanks.

      Where did this data come from?

      Also, if the drug is not absorbed and no change in QT interval etc., why would there be such a difference?

      Does this mean the drug is absorbed?

    • It is not statistically significant. Get real....Stop spinning data....

      • 1 Reply to jiarealty
      • yes thank you for pointing this out..

        so you notice too, how optr loaded a lot of 'less important'(imo)negatives on Vanco to even out the 'more important sae's' (imo) on the fida side.

        here's what i mean... let's take a look at the bottom half of the SAE's

        Mental status: Fida 0 Vanco 3
        Dehydration: Fida 0 Vanco 3
        Hypokelimia: Fida 0 Vanco 3
        Dyspnea; Fida 1 Vanco 3
        Renal Failure; Fida 1 Vanco 3 (apparently different from acute)
        Hyperglycemia Fida 1 Vanco 3

        Total Severe adverse events;
        Fida 3 Vanco 18.

        Voila! Optr concludes Adverse events are about the same in Fida and Vanco.

        aloha,
        kamoa

    • I labeled these 'very important events for a reason.
      I believe they have something to do with the drug treatment... there's no denying.

      you claim that fida is not absorbed systemically. common sense and experience with cuts tell me otherwise.

      as for pneumonia... we can conclude that fida is better than vanco in treating it... but that isn;t the endpoint of the study.

      i would like to see the results of the other study before i can draw a conclusion... anyway it will be all moot come may 30.

      aloha,
      kamoa

      • 1 Reply to kamoa_1
      • Is it safe to conclude that Vanco is three times safer than Fida?
        This can't be real?
        Is it?

        You asked 3 questions. The answers are "No", "No", and "No".

        Read a pharmacology book for starters (take a special look at the pharmacokinetics chapters), then move on to biostats, and then study pharmacovigilance and how adverse events are captured during a clinical trial. Then ask your questions - and you'll come up with "No", "No", and "No".

    • phaseiii@ymail.com phaseiii Mar 20, 2011 11:23 PM Flag

      komoa, you ok from that ownage contrarian just handed you??
      lmao, you clearly fail at instilling fear.

      You must have taken vanco at some point
      Mental status changes
      Fida 0 Vanco 3

      I would file suit against VPHM, no human should have their brain impaired as you have

    • Wow, kamoa, did you know 6.5% of patients died in the Vanco group vs only 5.3% in the Fida group? Can it be concluded that treatment with Vanco leads to higher incidence of mortality? Maybe the patients on each drug were very sick, and the deaths were not attributed to Vanco or Fida treatment?

      You are wrong on your SAE analysis, and you cherry pick data to postulate a false conclusion.

      First off, Fida is not absorbed systemically, and is mainly excreted in fecal matter. So, many of systemic SAE's you list are not attributable to drug treatment.

      Supporting this are normal liver function tests and cardiac parameters for Fida.

      Cardiac failure, Atrial fibrillation, and acute Renal failure that you mention in your argument cannot be due to Fida treatment.

      BTW, Renal failure (non-acute) occurred in 1 Fida and 3 Vanco patients. The highest occurrence for any particular SAE was 1.3% for Fida and 1.5% for Vanco group with this one being pneumonia. Wow, Vanco treatment results in higher incidence of pneumonia vs Fida treatment. Can't pneumonia kill you?

      "In the fidaxomicin treatment group, 75 subjects (25.0%) reported SAEs compared with
      78 subjects (24.1%) in the vancomycin group (Table 2). For all-cause mortality, among the
      subjects with SAEs, 16 subjects (5.3%) in the fidaxomicin group and 21 subjects (6.5%) in
      the vancomycin group died. None of the deaths were considered related to the study drugs
      by the investigators."

      Source: http://www.optimerpharma.com/gallery/OIU090733safetyPoster9_2946271_94.pdf

    • Why don't you cherry pick pneumonia...or hypokalemia...or whatever. Your analysis mean nothing.

      http://www.optimerpharma.com/gallery/OIU090733safetyPoster9_2946271_94.pdf

      Cherry pick all you want.

 
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