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    Tuesday, August 31, 2004

    Oh, Those Statins: New research suggests that giving high doses of those beloved cholesterol lowering drugs, the statins, after a heart attack, will dramatically reduce the incidence of further heart attacks and strokes and chest pain:

    An aggressive, high-dose regimen of cholesterol-lowering drugs within days after a heart attack may reduce further heart problems, says a new large-scale study.

         Doctors from Boston's Brigham and Women's Hospital joined a team of national researchers to track nearly 4,500 patients in 41 countries for up to two years.

         They found those who were given a 40 milligram daily dose of cholesterol-lowering statins for a month, followed by an 80 milligram daily dose for up to two years suffered fewer heart problems compared to those given a placebo the first month followed by a 20 milligram daily dose.

          "There was a 25 percent lower rate of death or major cardiac event after four months in the 80 milligram group,'' said Dr. James de Lemos, a cardiologist at the University of Texas and lead author of the study in the Journal of the American Medical Association.

    Here's their data. They placed 2232 heart attack patients on a placebo for four months, then on 20mg of simvastatin thereafter and followed them for two years. They placed 2265 heart attack patients on 40mg of simvastatin for one month followed by 80mg for the next two years. Then, they counted the number of those patients who had heart attacks or strokes or who had to be admitted for chest pain during those two years.

    Of those taking actual drugs from the beginning, 14% had a cardiovascular illness during the follow-up period. Of those who started out with placebo, 17% had a cardiovascular event. Death from a heart attack or stroke occurred in 5.4% of the patients initially given placebo and in 4.1% of those getting high dose statins - the other events (non-fatal stroke, heart attack, and chest pain) occurred at the same rates in the two groups.

    That's not a great change in individual risk. And when you consider that one month of 80mg of simvastatin (Zocor) is $124, you have to wonder if it's worth it.

    Of course, there's the rub. If someone else, say an insurance company or Medicare, is paying the bill, then it's worth it for most people. But if they have to pay, then it's not.

    As the Boston Herald story noted, this is the third study advocating the use of high dose (and high price) statins for prevention of heart disease. It will be a very big deal if their conclusions become widely adopted, considering the billions of dollars involved. We would do well to ask ourselves if its really worth it.

    UPDATE: Reader email on the economics of statins:

    I think your economic comment is incorrect.

    One month of 80mg costs $124 or about $1500/year

    Outcomes are better by 1%.

    If this improvement occurs over one year, then the cost saving one life is $150,000/life-saved.

    As a general rule, cardiac patients successfully treated live on average about 10 years. Therefore the cost is $15,000/life-year-saved. If it's 1% over two years, it's about $30k/life-year-saved.

    Cost-effectiveness is currently about $50-80k/life-year-saved. Based on this back of the envelope calc, high-dose statins are cost-effective. This does not account for costs of avoided ICU stay, other complications (stroke et al), and so on.

    That's assuming that the advantage for high dose statins continues beyond two years. We don't know that it does.

    There has been one study that looked at the overall mortality for ten years, using traditional doses of simvastatin (40mg instead of the 80mg used in the most recent study). In that study, 21% died in the placebo group after ten years compared to 19% in the simvastatin group. (That was of all causes, not just cardiovascular disease.) But again, we don't know if the same holds for high dose statins. The studies simply haven't been done yet. Keeping in mind that the higher the dose the greater the chance of side effects, the prudent move would be to proceed with caution.


    posted by Sydney on 8/31/2004 07:20:00 AM 0 comments


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