PCSK9 inhibitors

Discussion in 'Ask Dr. Dave' started by Anonymous, Mar 26, 2015 at 11:03 AM.

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  1. Anonymous

    Anonymous Guest

    Hi Dr. Dave, what are your thoughts on the new dyslipidemia meds, Repatha and Praulient, due to launch in August? As of now are you planning on prescribing them? Do you have a lot of statin-intolerant patients? Thank you!
     

  2. DrDave

    DrDave Member

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    Certainly statin intolerance is a common occurrence, but I'm not yet familiar with the risk reduction data for those agents. Do you have some info re: the cardiovascular risk reduction data?

    Thanks for posting!
     
  3. Anonymous

    Anonymous Guest

  4. DrDave

    DrDave Member

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    Very interesting, thanks for the links.

    If I'm doing the math correctly, the NNT to prevent 1 event over 1 year is 85. Impressive for the short duration, though it looks like there was a fair amount of heterogeneity in the patient population from the parent trials (high risk Japanese patients, familial hypercholesterolemia patients, etc.). Also, patients who had been exposed to the drug in the parent trials with adverse events were excluded if I understand the study design.

    So...intrigued, anxiously awaiting larger study results, but not sold quite yet.
     
  5. Anonymous

    Anonymous Guest

    Thank you Dr. Dave-I appreciate your insight. It's still early-looking at August approval I think. I'll be back when I'm trained and have more information.
     
  6. anonymous

    anonymous Guest

    Hi Dr. Dave-have you heard any more about the pcsk9 inhibitors?
    Sanofi/Regeneron's likely about to be approved & a month for Amgen's. That's a whole thing-Sanofi spent 67 million to basically "cut the line" & get earlier decision.
     
  7. DrDave

    DrDave Member

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    Not anything new clinically - anything else that has evolved (besides approval news) that you think is pertinent for discussion? Thanks for posting, sorry for the delay in response!
     
  8. anonymous

    anonymous Guest

    do you have patients in mind for Praluent or Repatha?
    Have you had or do you have an Amgen/Prolia rep calling on you?
     
  9. DrDave

    DrDave Member

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    Not yet (IE, there might be some that I haven't identified), and I haven't had an Amgen rep call on me for a year or more.
     
  10. anonymous

    anonymous Guest

    Hi Dr. Dave,
    Have you been detailed on or read about the two PCSK9 inhibitors yet? I represent Repatha. Just letting you know where I'm coming from.
    I would love to hear your thoughts about them and if you have or intend to prescribe either one.
    Also, two more specific questions please.
    1-Repatha can be used for up to 30 days once it's at room temperature whereas Praluent can only be used 24 hours past room temperature. Do you think this is a big deal or significant advantage for Repatha?
    2-Both of these mess need to be/should be entered into a "hub" in order for patients to get free/bridge medication, copay assistance, prior authorization paperwork, and additional benefits like nurse education. They're specialty pharmacy drugs. Do you see that as a negative or something you'd rather not do?
    Thank you!
     
  11. DrDave

    DrDave Member

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    I have not yet used these meds, although there may be a couple of patients with very high LDL, CVD and statin intolerance in whom I would consider it. Correct me if I'm wrong, but there is no RCT looking at this population specifically that demonstrates risk reduction (though there is some risk reduction in the heterogeneous population cited above). The FDA indication language is all about LDL lowering from what I've seen. Re: your questions above:

    1. The 30 day room temperature window is a plus;
    2. Although a bit of a thrash, I don't see it as prohibitive. New drugs are always a little more work to prescribe, and the number of pts for me is small.

    In summary, I may have a small number of niche patients in whom I would consider rxing, and I haven't seen any data that has put me in a rush to prescribe.

    Thanks for posting!