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    The Failure of Vytorin and Statins to Improve Cardiovascular Health
    avatar
    bobby75703 posted:
    The Failure of Vytorin and Statins to Improve Cardiovascular Health: Bad Cholesterol or Bad Theory?


    The article in full:
    http://www.jpands.org/vol13no3/peskin.pdf
     
    avatar
    toneman84084 responded:
    Interesting but dated article. It's strange to tie this the ENHANCE trial which only indicated that the addition of Zetia to Zocor showed now additional benefit compared to Zocor alone, this article would have been just as compelling without confusing it with ENHANCE.


    Some thoughts here to be aware of for sure, perhaps the biggest one is at the bottom;

    Potential Conflict of Interest:
    Brian Peskin is also a consultant to nutritional
    companies.
     
    avatar
    bobby75703 replied to toneman84084's response:


    The fact that is -

    STATINS HAVE YET TO PUT A DENT IN THE DECLINE RATE OF DEATH FROM HEART DISEASE!


    Wake up America!
     
    avatar
    bobby75703 replied to bobby75703's response:
     
    avatar
    toneman84084 replied to bobby75703's response:
    You don't know that because you can't say where the rate of heart disease would be without statins in today's world. The life we live today is nothing like the lifestyles of those that came before us, it really is that simple so you are not comparing apples to oranges.

    This whole article harps on NNT's, I think this forum is the only place where so much emphasis is placed on NNTs. Here's the dirty little secret....... Doctors do not care about NNTs when discussing statins or certain other classes of drugs based on the very nature of the disease they are trying to prevent. There are too many other risk factors other than cholesterol that will cause a cardiac event. Bobby, do you have a cardiologist? If so ask him what he thinks about NNTs.

    Here's the reason, look at the data I read this morning from another poster discussing the CARE trial concerning the make up of the participants;

  • 59 years old; 14% women; 66% from the US, 34% from Canada.
  • 43% hypertensive; 21% current smokers; 15% diabetic; mean BP 129/79.
  • Q-wave MI: 61%; Prior CABG or PTCA: 54%; ejection fraction: 53%.
  • Aspirin use: 83%; beta-blockers: 40%; calcium-blockers: 39%
  • Plasma lipids (mg/dl):

  • How can you properly compare my results to some one who is hypertensive and smokes? How can you compare my results to some one with previously diagnosed CAD or has undergone a coronary bypass? How can you calculate an NNT comparing me with the individulas above with other risk factors? It's apples to oranges!

    Statins DO NOT:

    1) Control Blood Pressure.

    2) Cure the effects of smoking.

    3) Bring damaged heart cells back to life.

    4) Do not open already blocked arteries.

    5) Don't cure diabetes.

    6) They also won't keep you from being from Canada but I doubt if that matters.

    All of these things will cause a cardiac event on it's own (except being from Canada), cholesterol not withstanding. You can treat your cholesterol but keep smoking and you have a high risk of a cardiac event still. As you like to say, half of all those that die of a heart attack have normal cholesterol. What you don't say is that some smoke, some have diabetes, some have had previously diagnosed heart disease and now have their cholesterol under control, some have had previous heart attacks with damaged heart muscle and now have controlled cholesterol and on and on.

    The only way to get an accurate NNT is to have clean control groups, only compare me to individuals with my risk factors. 4S is the only study to do this fairly effectively and it ended with an NNT of 11.7 which still means nothing based on the very nature of CAD.

    You can keep calling America to wake up, but the facts are not all in yet. Some day you may well be proven right, but we don't have the type of data we need yet to make that judgement. Some of that falls on the drug companies, some on the anti-statin group that twists every number it can to suit their needs, some falls of doctors not being as concerned as they should be, however the needed data just does not exist yet to say that statins do not impact the risk of CAD.

    So we can all argue NNTs for the rest of our lives, but that won't change their irrelevance to the nature of the situation. NNTs are just a number used by the anti-statin group to support their point because they look good for their cause but are really meaningless given the data at hand.

    Rant off...................
     
    avatar
    bobby75703 replied to toneman84084's response:
    "You don't know that because you can't say where the rate of heart disease would be without statins in today's world."


    Yes I do know. History shows the death rates from heart disease declining long before statins. In fact the decline in death rates from heart disease were best from 1970-1975. Statins appeared in 1988, with absolutely no enhancement of the decline rate.


    We made the best progress from 1970-1975 while McDonalds fried in beef tallow and fast food sales grew like wildfire.




    "NNTs are just a number used by the anti-statin group to support their point because they look good for their cause but are really meaningless given the data at hand"


    100% false. NNT scoring was developed by the drug companies themselves as an expression of absolute risk reduction. NNT's are valuable data and measure the true performance of a drug.






    "4S is the only study to do this fairly effectively and it ended with an NNT of 11.7 which still means nothing based on the very nature of CAD."


    4S was funded by Merck for there own Simvastatin product. Anyone has the right to accept industry funded studies. I don't accept them. I take the advice of a physician. "IGNORE industry funded studies." They are not worth the paper they are written on.





     
    avatar
    bobby75703 replied to bobby75703's response:
     
    avatar
    bobby75703 replied to bobby75703's response:
    Under the new guidelines, I believe in this decade will witness a string of failures on studies of cholesterol lowering drugs.

    Both Vytorin in the ENHANCE study, and Niaspan in the AIM-HIGH failed miserably. I think this is only the tip of the iceberg.

    Get ready. Fasten your safety belts. This is gonna be a wild ride that will leave medical professionals perplexed and frustrated.

    Development of new poly pills will fail to prevent cardiovascular disease, heart attacks, and strokes.

    Consumers will become disillusioned. Patents will expire on name brands. Sales of brand name statins will plummet. Eventually there will only be dust and ashes left to the statin economy, and millions of injured patients left in its wake.

    That's my prediction.
     
    avatar
    billh99 responded:
    Very poorly written article.

    "The clinical failure of the drug Vytorin—the ENHANCE Trial
    (The Effect of Combination Ezetimibe and High-Dose Simvastatin
    vs. Simvastatin Alone on the Atherosclerotic Process in Patients
    with Heterozygous Familial Hypercholesterolemia)—is prompting
    a reexamination of the basis for using cholesterol-lowering drugs,
    the statins."

    Because ezemtimibe statin is no better than statin alone it is time to look at statin. Makes absolutely no sense at all.

    More likely a means more look at ezemtimibe. He just used it to go off on his rant about statins.

    And in fact on there have been a number of articles about the ineffectiveness of ezemtimibe.

    From my reading it seems that after treating to goal with statins then there is no more improvement by trying to change cholesterol.

    He makes a couple of other completely illogical jumps in the article.

    But I believe that there is some truth in his article. He discusses the possiblity of ApoB might be an indicator athrogenetis (sp?) and that is the carrier for LDL. And statins do reduce it.

    Unfortunately I don't understand enough of biochemistry to follow all of his statements about the different FA's and cholesterol components.

    But I agree that just measuring TC, LDL, & HDL is probably not the best indicators of future heart disease, but they are the best that are currently available.

    Likewise with statins.
     
    avatar
    toneman84084 replied to bobby75703's response:
    Yes I do know. History shows the death rates from heart disease declining long before statins. In fact the decline in death rates from heart disease were best from 1970-1975. Statins appeared in 1988, with absolutely no enhancement of the decline rate.

    No Bobby, you don't. You do not have any way to quantify the effects of one's life style in 1975 to one's life style in 2011. You yourself are always talking about the environmental and nutritional differences, do you no longer believe that to be true?

    I don't accept them. I take the advice of a physician. "IGNORE industry funded studies." They are not worth the paper they are written on.

    You accept the opinion of YOUR physician, not mine who believes otherwise.

    100% false. NNT scoring was developed by the drug companies themselves as an expression of absolute risk reduction. NNT's are valuable data and measure the true performance of a drug.

    No, NNTs and ARRs were required as a measurement by the FDA, not something the drug companies just created, but you know that as well. Even the FDA states that NNTs are influenced by many outside factors and are not always reliable and recommends using RRR's. But we've already discussed that.

    Bobby, don't make an argument about this, I appreciate your opinion, mine is just different. We don't look at the data you've presented the same way.
     
    avatar
    toneman84084 replied to billh99's response:
    Very poorly written article

    I absolutely agree, but it was written by a Nutritionist from his point of view. There are many confusing and troubling reaches in many of his statements, I view this as an opinion paper not a true analysis.

    In addition, this article is a bit out dated and really nothing that we have not read or heard before. Maybe is should find a picture of the slogan "what you talkin' about Willis" to post with my thoughts as cute little slogan pics seem to be in now.

    But I agree that just measuring TC, LDL, & HDL is probably not the best indicators of future heart disease, but they are the best that are currently available.

    We also both agree on this, it is the best we have at the moment until some one provides us something better than just guesses.
     
    avatar
    bobby75703 replied to toneman84084's response:
    If statins were effective, there would be no argument.
     
    avatar
    Sir_Porangi replied to bobby75703's response:
    You are so so correct.

    If "high" cholesterol was such an enemy and if statins were such a savior how come people die, get stents or bypass operations when they have LOW CHOLESTEROL.

    The overly hyped predicted NNT factor is severely erronous just on the basis of ignoring all the horrific smothered side effects 10,000's of statin victims suffer.

    WAKE UP AMERICA - WAKE UP OUR HEALTH AUTHORITIES


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