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Every night like five million other people world wide, I take Vytorin- at least until tonight.  My cholesterol is high and my family history is one of cardiovascular problems.  I control my blood pressure with generic medications (a low dose diuretic and beta blocker, both generic), work on losing weight and blog to reduce some stress.  

Tonight the article published an article indicating that Vytorin has been shown to not reduce plaque formation in arteries, and may even marginally increase the plaque formation.  I am contacting my physician about this and maybe you should too.

Vytorin is a mixture of an earlier drug, Zocor and a newer drug, Zetia.  Studies show Vytorin reduces cholesterol better than Zocor alone.  Vytorin is a blockbuster drug and its manufacturers, Scherring-Plough and Merck conducted a two year study, ending in 1996, in order to confirm the effectiveness of the drug combination on arterial plaque- a bad actor in cardiovascular disease.  Reducing cholesterol is good, right?  So a drug that reduces cholesterol better should reduce cardiovascular disease better, right?  Well maybe it is more important to prevent cardiovascular incidents than to just reduce cholesterol.

In a press release, Merck and Schering said that not only did Zetia fail to slow the accumulation of fatty plaque in the arteries, it actually seemed to contribute to plaque formation — although by such a small amount that the finding could have been a result of chance.

Dr. Steven E. Nissen, the chairman of cardiology at the Cleveland Clinic, said the results were "shocking."

"This is as bad a result for the drug as anybody could have feared," said Dr. Nissen, a widely published researcher and senior consulting editor to the Journal of the American College of Cardiology. Millions of patients may be taking a drug that does not benefit them, raising their risk of heart attacks and exposing them to potential side effects, he said. Patients should not be given prescriptions for Zetia unless all other cholesterol drugs have failed, he said.

Over-reacting?  Maybe, but this is something I am now skeptical.  It has been two years almost since the author of the study concluded the clinical trials, and they have supposedly not sent the data on to the company until two weeks ago.  I began hearing rumors that there might be a problem with this drug a few months ago, but hadn't call the doctor to change prescriptions-waiting for the data.  The older drug has a better track record, and now that the data is in, I want to change to something with a track record of success.  

The House Energy and Commerce Committee, which is investigating the delay, said in a statement Monday that the negative results added to suspicions that the companies had deliberately sat on their findings from the study, which was known as Enhance.

"In light of today’s results, which were released nearly two years after the Enhance trial ended, it is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data," Representative Bart Stupak, Democrat of Michigan, said in the statement. Mr. Stupak is chairman of the committee’s Subcommittee on Oversight and Investigations.

Dr. Harlan M. Krumholz, a cardiologist at Yale, said drug companies had a responsibility to release all their trial findings, positive or negative, as quickly as possible — even if the results might hurt sales.

"People may have been on this drug without the ability to know that there was additional data that may have thrown into question its effectiveness," Dr. Krumholz said. "That’s extremely unfortunate, and that’s an understatement."

I do statistics and frankly, they must have been reanalyzing and looking at this data for months.  The study will be presented at a conference in March, but I am not going to wait.  I also suspect my somewhat inflated prescription price will go down with the older drug.

We need more data based decision-making for our drugs.  We should consider the possibility that the drug did lower cholesterol, and all prior drugs that lowered cholesterol lowered risk as reasonable.  But once they had data that indicated it wasn't better than a generic drug with a pretty good record, they owed it to us consumers to give us that information.

I already eat a low-fat diet, have been on Weightwatchers, try to exercise more,  but my genetics don't favor my success with this alone.  I'll be back at the doctors for a second look at my prescriptions.  Right now I have no vote of confidence in the pharmaceutical industry.  

Originally posted to murrayewv on Tue Jan 15, 2008 at 12:40 AM PST.

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Comment Preferences

  •  Tips..... (30+ / 0-)

    for more cholesterol reduction hints- I can try the niacin again I suppose, but had to stop when the higher doses of the slow release niacin were messing with my liver.  I guess the metamucil and oat bran and apples are back every day.

    You shall know the truth, and the truth shall make you mad. Aldous Huxley

    by murrayewv on Tue Jan 15, 2008 at 12:43:06 AM PST

  •  My partner (7+ / 0-)

    had 6 bypasses three years ago, we have been researching his meds for a while now.  He never really came back after the surgery, maybe 80 percent on the good days.  Any rec on good websites for updates and research?  

  •  I wouldn't panic. (5+ / 0-)

    I think you're doing the right thing by hitting up your doctor for advice.

    It's not a large study AND:

    The Enhance trial covered patients who have a gene that causes them to produce high levels of low-density lipoprotein cholesterol, commonly called LDL or bad cholesterol. Patients in the trial had LDL levels of about 320 milligrams per deciliter at the beginning of the trial, about three times the level cardiologists deem acceptable.

    The results of the study are counterintuitive, it's cholesterol that causes plaques... and...

    Over the two years of the trial, patients who took Zocor alone reduced their LDL by 41 percent on average, while patients who took Vytorin reduced their cholesterol by 58 percent.

       So the results are from a population that has an abnormal cholesterol metabolism in the first place, and the results may not hold for the general population, generally speaking the lower someones cholesterol the better, or at least that is what I've read.

    P.S.  Yes I hate drug companies, this just an appeal to anyone who's freaked out by this to take it in stride.

    •  I am pissed they weren't honest..... (3+ / 0-)
      Recommended by:
      Paulie200, SnowCountry, binkaroni

      I did take my pill tonight after thinking about it.  But I do think another, more proven treatment that costs less would be good.  I was really bringing things down more with diet and exercise but then it just hit a plateau.  So I tried the Vytorin and it went down very well.  I have both parents and most family members suffering strokes or heart attacks and I want to ward off the risk.  I think the lifestyle factors are big.  I never smoked and do't drink much- maybe 3-5 drinks a week (less when I am watching my weight, which is pretty much all the time).  I'm not a vegetarian, but I tend to eat very little meat to avoid the fat.

      You shall know the truth, and the truth shall make you mad. Aldous Huxley

      by murrayewv on Tue Jan 15, 2008 at 03:21:38 AM PST

      [ Parent ]

  •  I have a friend on Vytorin. (5+ / 0-)

    She just started taking it the last two months. Guess I will tell her about this. Geez, this is just a rip off.

    "Though the Mills of the Gods grind slowly,Yet they grind exceeding small."

    by Owllwoman on Tue Jan 15, 2008 at 03:24:48 AM PST

  •  Big Pharma strikes again! (5+ / 0-)

    The article you link to does have a few inaccuracies. One of the quoted doctors states that progression of plaque is "the only way you have events". This is not true. You can have a plaque which is not enlarging, which may even be shrinking, but if it becomes unstable- that is, soft and fragile- it is more likely to rupture and cause a sudden occlusion (blockage) and heart attack.

    There are some patients who just can't take any of the statin drugs due to muscle pain. For them I've been resorting to Zetia on occasion, but this study certainly calls that into question.

    BigPharma has a long and detestable history of suppressing unfavorable results. The most notorious example was a trial funded by the manufacturer of brand-name Synthroid (JAMA 1997;277:1205-18). They hired one of the most accomplished thyroid researchers in the world to run the study which attempted to prove that the brand-name drug was superior to generic. The study instead proved they were equivalent. The parent company (Boots Pharmaceuticals) moved to suppress the unwelcome results. When the researcher went to publish the results, the company launched a despicable campaign of character assassination and intimidation to keep it out of print. To their immense credit, the brave researcher stuck to her guns and published this important study; JAMA supported her and added an editorial comment slamming the company for its grotesque behavior.

    Legislation has been proposed several times that would compel BigPharma to release negative results of trials, particularly trials funded with Federal dollars. Three guesses who has been blocking this legislation and the first two don't count.

    •  when Pharma funds the studies..... (3+ / 0-)
      Recommended by:
      votermom, SnowCountry, binkaroni

      twice as likely to get favorable results.  Really, researchers need to be very independent of them.  I completely agree on releasing all the data.  I was also pissed off over the whole estrogen supplemetation without studies to show its effectiveness.  That one turned out to be not so good either.

      This was an extreme study, but it is still one which they predicted should have good results.  I didn't know about releasing the plaques- certainly something to consider.

      You shall know the truth, and the truth shall make you mad. Aldous Huxley

      by murrayewv on Tue Jan 15, 2008 at 03:44:07 AM PST

      [ Parent ]

    •  Well... (5+ / 0-)

      I won't be the first one to stand in defense of big pharma...the delays in getting this data our are of some concern. But there's a lot of disinformation being tossed about too. Merck/S-P have some 'splainin to do, but there could be non-dastardly reasons for the delays too. Maybe...

      Zetia was developed in part because (as Ralphdog noted) some patients can't tolerate the high doses of statins that are needed to bring LDL levels down sufficiently. Its mode of action is different from that of statins, so it can theoretically be combined with statins to provide greater efficacy. This was demonstrated in multiple clinical trials in patients with high baseline LDL levels as a basis for its initial FDA approval. IIRC, Zetia when combined or on it's own dropped LDL by about 15-20 points.

      Unlike those studies, the ENHANCE study used genetically proven heterozygous familial hypercholesterolemia (HeFH) patients to test the study drug. This is a relatively small percentage of the population that have very high LDL levels. The reason for using this population is simply that it is predisposed to having cardiac events (more of them at earlier ages), so it's easier to detect the events in just a few years, compared to the many years that would be required if you did the same study in patients who just had elevated LDLs.

      Some of the other complaints about the ENHANCE study were the time it took to release the results, and that the primary outcome measurement (IMT = imtima media thickness) may have been changed before the final analysis.

      I know the group that did the IMT measurements (though am in no way connected to them or to anyone at Merck/S-P) and am pretty confident that:

      a) collecting and analyzing IMT data from 725 patients over multiple assessments can and does take a lot of time and effort--even by professionals. The work involved in making the IMT measurements is also time-consuming and resource limiting (the assessors have to be trained specifically on how to do these measurements). While one would think Merck and S-P would not have resource constraints, the constraints are not on their end, but on the end of the group in Amsterdam (and that's a small academic group). That said, if Merck and S-P had wanted to make this move faster, they probably could have, but would not have been so keen to have this out--speculation, sure--but not unrealistic.

      b) the primary outcome was not likely to have been changed--that group in Amsterdam has been disputing internally the propriety of using carotid IMT vs femoral IMT for quite some time now--and this probably led to the delays and subsequent clarification that carotid IMT would be the primary endpoint, with the others moving to secondary endpoints. In any case, you can really only have one primary endpoint, so to have several was just wrong from the start.

      Now, it's a bit hyperbolic and dishonest of Steve Nissen to to claim that millions of people may be taking a drug that does them no good, and may even do harm. He's very much aware of the basis of approval for Vytorin and knows darn well that it was approved on surrogate endpoint data. So while I don't know what his prescribing patterns are, I'd be willing to bet that he's given Vytorin to more than a few patients who didn't need it because they couldn't tolerate statins. I'd also be rather shocked if Steve Nissen was not a scientific adviser to Merck/S-P for ENHANCE, as he has been on most every significant cardiovascular study in the past decade (including Pfizer's torcetrapib study).

      My advice to you:

      Zocor is a good drug and has been around for quite a while. It's cheap, being off patent. If you are able to tolerate the 80mg dose of Zocor, ask your doctor about trying that should you need to further reduce you LDL levels (you might also ask him/her why they put you on Vytorin in the first place if you want to go there...). If you're not able to tolerate the necessary dose, you may want to consider staying on Vytorin, unless you happen to be HeFH.

      Dieting is probably the most safe and effective means of changing your cholesterol level, albeit the most difficult for most people. If you can do it, that's great--keep it up.

      Niacin does not reduce your LDL, rather, it increases your HDL (the good cholesterol). I'm not sure there is any definitive evidence that this lowers your chance of risk, but if the side effects are not bothering you, and your doctor agrees, no reason not to continue with it.

      Be careful about other "medications" such as herbals and such...make sure your doctor knows about those you're taking so he/she can try to minimize any drug interactions.

      •  I will ask why- (2+ / 0-)
        Recommended by:
        SnowCountry, binkaroni

        but I suspect it seemed like a good choice because it was flavor of the month.  I haven't tried statins, but I was concerned with the mental issues associated.  My brain is my livelihood and I would prefer to be sharp if possible.  But not if it means I am dead.

        You shall know the truth, and the truth shall make you mad. Aldous Huxley

        by murrayewv on Tue Jan 15, 2008 at 05:59:10 AM PST

        [ Parent ]

        •  Sorry, but Zocor is a statin (2+ / 0-)
          Recommended by:
          murrayewv, Ralphdog

          Sorry if I've confused you any. Statins are a class of drug of which Zocor is a member. Others are Lipitor, Crestor, etc. They have other names too (Zorcor is Simvastatin, Lipitor is Atorvastatin, blah, blah, blah).

          I guess my point in that long rant was that you shouldn't just give up on Vytorin if it was working for you, just because of this study. I've not seen anyone say it was not a safe product.

          On the other hand, if you don't need Zetia (=Ezetimibe), then you shouldn't pay for it since it's quite spendy and not necessarily giving you what you need. For example, if you are currently taking the 40mg Vytorin (40mg Zocor; 10mg Zetia), then you have room to work with. You could go to 80mg Zocor (highest labeled dose) to see if you can do as well or better than the Vytorin did for you. If so, then you're good to go.

          •  I am a on a low dose and it does work well..... (1+ / 0-)
            Recommended by:
            SnowCountry

            I am due to speak with my doctor anyway- so this will make me do some more research.  I really appreciate your feedback on this issue.  All the other things like diet stress and exercise I try to do anyway but lose motivation when the darned pill worked so well.  I am going to redouble those efforts and be more critical in evaluating the drugs- I like the idea of trying the statin alone and maybe with the 800 mg of niacin and see how it does for cholesterol and liver.

            You shall know the truth, and the truth shall make you mad. Aldous Huxley

            by murrayewv on Tue Jan 15, 2008 at 09:42:47 AM PST

            [ Parent ]

  •  more about Yoga... (5+ / 0-)

    I first encountered it as a gym-class-alternative in a progressive jr. high school. The handful of things I got from it helped me stay flexible, sleep during college, and a few years ago I started up again. Two of the teachers that I've had introduced themselves by saying "when the doctor told me I would need to have back surgery, I had to find an alternative, and so years later here I am." If you've never ever done it before, I suggest starting here:
    Yoga for the Rest of Us. She's standing in the picture, but the video actually has a lot of in-the-chair-yoga and both men and women doing the routine with all ability levels demonstrated.

  •  Wow, thanks for the heads up on this (4+ / 0-)
    Recommended by:
    murrayewv, Temmoku, SnowCountry, binkaroni

    I have been using Vytorin for over a year and have gotten very good results on my overall cholesterol, but it has not done much for my triglycerides, which continue to climb.

    "I'm not a member of any organized political party, ... I'm a Democrat." Will Rodgers

    by CCSDem on Tue Jan 15, 2008 at 04:08:00 AM PST

  •  HDL and LDL Cholesterol are a big problem (3+ / 0-)
    Recommended by:
    murrayewv, SnowCountry, binkaroni

    My Husband also had high Triglicerides...
    I'm talking 595 and Cholesterol also in the 498 range.
    For years we tried diet and exercise. No red Meat, lots of oat bran muffins, olive oil, no butter or margarine...I was on the diet too, it was just easier. My cholesterol was always 159 until about 5 years ago and it shot up to 229. But then, I am a sucker for chocolate donuts. And, of course my weight is up and I don't exercise. He exercises every day while I do housework. (BTW, he does NONE!!!!) He is on Lipitor (a horse pill size) and I'm on Vytorin (about the smallest pill I've ever seen). He has been on it for years but his cholesterol is still high in the upper 200s and so are his triglicerides. I am sure I can stop my pill since the dose is so low and I've only been taking it for a year, besides, I see the doctor tomorrow anyway...but someone like my husband would be in trouble....Diet and exercise are not enough, especially when heredity is a major factor.

    All I want is....Impeachment followed by Imprisonment!

    by Temmoku on Tue Jan 15, 2008 at 06:03:15 AM PST

  •  Lots of good research for diet (4+ / 0-)
    Recommended by:
    JayDean, murrayewv, Temmoku, SnowCountry

    Diet changes have been shown over and over to be the best, cheapest, safest, most dramatic way to lower cholesterol and reduce heart incidents. The change involves giving up rich foods that many people feel they cannot live without, so it's not immensely popular.

    It seems like you're already on that path. Even more small changes can bring you further improvement--it all adds up. Consider some of the programs below, all of which eliminate meat and dairy for the most part, reduce added fat to almost zero, and focus on whole foods instead of processed food. That along with moderate exercise (like daily walking 30 minutes) will bring you more improvement. It can't hurt you to try, it's inexpensive, safe and even reversible in case you change your mind.

    Pritikin
    Dr. Dean Ornish
    Dr. Esselstyn
    Prof. Colin Campbell (read his book The China Study)
    Dr. Joel Fuhrmann
    Dr. Neal Barnard
    Dr. Neil Pinckney
    Dr. John McDougall

    All of the above have excellent books and websites. My husband and I started following the McDougall program 5 years ago. At the age of 48, my husband's cholesterol was 247. He has several members of his family with heart disease. Rather than start medication (which he was afraid of, due to liver side effects), we changed our lifestyle--his cholesterol came down to 160 and has stayed there, he lost 30 pounds and has kept it off, and he enjoys the food and eats his fill. We are both much healthier, energetic and thinner than our colleagues the same age.

    Thanks for the diary--I hope people's suspicions are raised about taking medications just to treat the numbers on their cholesterol test. What about your longterm health? That can't be improved with drugs. Best of luck to you!

    [-5.50, -8.05] and in good company. FreeRice level: 50 (good guesser)

    by sillia on Tue Jan 15, 2008 at 06:12:34 AM PST

  •  I have great cholesterol numbers (1+ / 0-)
    Recommended by:
    SnowCountry

    My dr called them beautiful (lol).

    I'm a low-carber. I recommend that. The only oil I cook with is olive oil (from costco). I eat all the good fats and shun low-fat stuff. Eat 70% & up dark chocolate in little bits.

    The only thing is I neglect taking vitamins  because I hate pills -- but don't do that. Vitamins are good.

    And take citrucel or something like it. Fiber is good.

    •  can't do low carb- (1+ / 0-)
      Recommended by:
      SnowCountry

      too much fat and meat for me- I just wind up gaining weight.  I can do more Ornish with lower fat.  Different strokes I guess, but lower weight is a goal (or hopefully no strokes).

      You shall know the truth, and the truth shall make you mad. Aldous Huxley

      by murrayewv on Tue Jan 15, 2008 at 09:45:19 AM PST

      [ Parent ]

      •  how about (1+ / 0-)
        Recommended by:
        murrayewv

        the Zone or South Beath type diets? My sister has type II diabetes and got it under control by following teh Zone sort of eating, so she swears by it.

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