Monday, November 10, 2008

Crestor Study - What does it really mean?

The headlines are screaming that Crestor is the best when it comes to reducing heart disease. But before we all start buying AstraZeneca stock (not that this is a bad idea), maybe we should take a look at what the news actually is here. The study, named JUPITER, was designed to test Crestor's effect on those who have elevated levels of C-reactive proteins--or actually high sensitivity, or hsCRPs to be perfectly accurate. Researchers have begun to suspect that heart disease is not caused by a gunky build-up of cholesterol in the arteries, but rather is a far more dynamic process. Yet, when one reads the coverage of this study, it's clear that no one is actually getting this key point. And here's another issue--the results trumpeted from the rooftops are simply not as good as they first appear. One issue to consider is that the trial was stopped early, because of its favorable results. Thus, a trial that was expected to measure heart disease results over several years was stopped after less than two years. How much can we really garner from such a short term study? And, despite the impressive sounding reduction--50% overall, and 38 percent for those with normal cholesterol, the actual numbers are a lot less exciting.

As pointed out in a nice BusinessWeek story on the topic:

"Dr. Andrew Tonkin, head of cardiovascular research at Monash University in Melbourne, Australia, cautioned that the actual number of heart attacks and other cardiovascular events was low, even in the study participants that were taking placebos. There were 83 cardiac events of all types in the Crestor group, an 0.9% actual risk, compared with 157, or 1.8%, in the placebo group. 'You would have to treat 180 people for two years to prevent one death," he said.'"

Ummm. Okay, sorry to be a party pooper here but ... are you telling me that they stopped the study based on a 74-person, .9% difference? What if the results were reversed in the second two years? There's no reason that couldn't happen, is there?

Believe me, I'm glad this study was done, because first of all it could save some lives, which is the most important thing. Secondly, it is yet another nail in the coffin of the cholesterol theory--though of course few people recognize this. And finally, it's important that statins be tested on wider populations. This was the first study that included a signficant number of women. But for pete's sake, can you at least finish a study before you declare victory? On such a short term, there's a good chance these were spurious. Don't you agree?

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