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 Re: Statins could reduce the risk of heart attacks and strokes for everyone (Re: Mohamed Omer)
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The Crestor Study Tells Us…? Mark Zucker Explains
By Ed Silverman // November 10th, 2008 // 4:53 pm
http://www.pharmalot.com/2008/11/the-crestor-study-tell...ark-zucker-explains/
The hoopla over the Jupiter study, which measured levels of a protein called CRP that can indicate arteries are inflamed and point toward heart disease, is prompting debate over a number of points - the extent to which CRP should be used as a guidepost for treating cholsterol, the wisdom in prescribing AstraZeneca’s Crestor and other statins to people with low cholesterol, and the study results themselves. An online survey run by The New England Journal of Medicine, so far, shows that 52 percent of respondents say the results will not likely have a significant impact on prescribing, 26 percent say it will likely have a significant impact, and 22 percent appear uncertain, according to Sanford Bernstein analyst Tim Anderson. We chatted with Mark Zucker, a heart treatment specialist at the St. Barnabas Health Care System and president of the American College of Cardiology’s New Jersey chapter, for some perspective. This is an excerpt
Pharmalot: What did the study tell you?
Zucker: It’s not unknown in the medical community that statins decrease inflammation. Therefore, the idea that statins might lower CRP isn’t at all surprising…What is surprising and reassuring is that we saw an effect in a relatively short period of time…It also suggests that our general sense, in the past, the the benefits of statins extend beyond their cholesterol-lowering effects is probably correct…In the short run the impact may be hard to asses, but in the long run, the study may have a profound impact on how we treat patients and shifts the paradigm from treatment to prevention
Pharmalot: Well, should everyone be tested for CRP?
Zucker: CRP is certainly a strong predictor of additional risk above and beyond cholesterol and LDL. For that reason, it is not unreasonable to screen patients for CRP elevations at least once during their 40’s or early 50’s
Pharmalot: Should statins now be given to people with high CRP and low LDL?
Zucker: That’s the crux of the study - what to do with patients with elevated CRP and acceptable LDL? Let’s first keep in mind that the target level of total cholesterol and LDL is somewhat arbitrary. We accept 70 mg/dl as the target, but in agrarian societies and in newborns, the LDL is generally less than 50 to 60 mg/dl. So, in reality it is unclear if the LDL in these patients was optimal. It probably wasn’t. It was just not particularly elevated by our standard. If you do choose to prescribe statins more liberally, this study provides at least some preliminary data to support your position. Nevertheless, putting patients on a statin to lower the CRP is certainly not an approved indication and does place the physician at some risk. At a minimum, one ought to recheck the CRP after three to six months of treatment just to ensure that the desired effect was achieved, otherwise, you might as well discontinue it until more data is available
Pharmalot: Should Crestor be widely prescribed? And what about other statins?
Zucker: A few points need to be considered. First, Crestor was the only drug studied. Second, it is the single most potent statin on the market. Third, Crestor it is expensive and it is not available as a generic. The cost treating the over 7 million Americans who might fall into the Jupiter cohort would be measured in the billions of dollars. Admittedly, upfront costs may save costs downstream by preventing CAD, CHF and CVA’s. Unfortunately, it’s a very hard analysis to perform. Certainly, the costs would be less if generically available statins had the same effect. This is not known and it is not good science or medicine to assume that all members of the class of statins will likewise decrease CRP. It may be true, but this is as yet unproven. From my point of view, additional studies will need to be done with other statins before recommending widespread use of Crestor or any of the sister statins
Pharmalot: What are the caveats?
Zucker: The study ran less than two years and there has been chatter among physicians over the past year or two that there might be an association between low LDL and the risk of cancer. While most of us are not convinced by the data, it would probably have been more prudent to not stop the study early and to instead follow all of the patients out for a longer period of time to make certain that no untoward or unexpected problems develop
Pharmalot: What about the higher incidence of diabetes?
Zucker: The absolute percentage difference between the cohorts was fairly small, although admittedly statistically significant. However, if you do enough analyses in any given study you always run the risk of finding something that looks statistically significant when it really isn’t. Let’s wait for additional data. Also, one would have expected that with all of the other statin trials done over the past 20 years, this ’signal’ would have already been noted
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Mohamed Omer
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