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March 13, 2006
The Big Statin Pillow Fight
The American College of Cardiology meeting in Atlanta is the source of all those news headlines today on cholesterol-lowering drugs. It can hard to make sense of all the studies that are being reported - my favorite confused headline so far is "Merck Says Vytorin Beats Zocor", to which the appropriate response is "It had damn well better". Beating Zocor is the whole reason that Vytorin exists, since it's Zocor (simvastatin) plus Schering-Plough's dietary cholesterol absorption inhibitor Zetia (ezetimibe).
The cholesterol-lowering market has long been vicious, but it's getting more so. There's a simple reason: Zocor's going generic this summer. Many managed-care organizations are looking forward to moving patients to the new, cheaper statin as soon as that happens, and companies are trying to come up with reasons to keep that from happening. Merck needs to show that they've got something better than their old drug, and other companies with their still-patented statins want to show that they do more than the generic will, too.
Thus AstraZeneca's big splash with their results for Crestor (rosuvastatin), where they showed arterial plaques actually reversing and getting smaller. I realize that drug-company-sponsored results aren't exactly in the highest standing these days. But the lead investigator on this study was Steve Nissen of the Cleveland Clinic, who is not exactly a tool of the drug industry, unless someone's updated the master list without telling me.
And that's clear from his own comments on the results, as opposed to those in the AstraZeneca press release. While impressed with Crestor's efficacy, Nissen did a good job putting things in perspective.
For example, he points out that he doesn't think that much more plaque shrinkage is even theoretically possible - most of the lipid content of the plaques has probably been taken out by this point. And he also mentions that no, this trial wasn't powered to say whether this effect actually improves long-term morbidity and mortality in patients (although you'd have to think it would, at least a little bit). Most tellingly, he makes the observation that everyone else's statins probably do the same thing if dosed to give a similar degree of cholesterol lowering.
AstraZeneca's argument has long been that gosh, nothing can lower cholesterol like Crestor, and I'm sure that much more in this line is coming. And Merck and Schering-Plough will continue to beat the drum for Vytorin, while Pfizer will never be known for their coyness about the benefits of Lipitor. But the Zocor patent expiration is just a coming-attraction trailer for this market. Its run as the cheapest effective statin in town will go on, arguments and advertising blaring all around it, for about three or four more years. And that's when Lipitor starts going off patent. You can bet that studies are already under way to try to show why people shouldn't switch to its generic when the time comes. . .
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