I should archive today's news about the lack of benefit from Vytorin (ezetimibe, marketed as Zetia/simvastatin) in the the "I knew it" category of the blog, if there was one. There have been a few medications I have had doubts about for a while. Among them were Zelnorm, Vioxx, Avandia and Zetia, and I had tried to discuss alternative options with patients who wanted a new prescription for them.Some examples of the blog coverage of the newly-released study are listed below:
Maybe lowering cholesterol does not matter. DB’s Medical Rants.
A quote from NYTimes: "While Zetia lowers cholesterol by 15 percent to 20 percent in most patients, no trial has ever shown that it can reduce heart attacks and strokes — or even that it reduces the growth of the fatty plaques in arteries that can cause heart problems. This trial was designed to show that Zetia could reduce the growth of those plaques. Instead, the plaques actually grew almost twice as fast in patients taking Zetia along with Zocor than in those taking Zocor alone."
Vytorin's Out, Simvastatin's In. Dr. Wes.
"A 30-day supply of Vytorin 10/20 (one of the lower-dose sizes), cost a whopping $97.17. Compare that to generic simvastatin 20 mg, at $5.82 - nearly 17 times the cost."
Unenhanced Results for Zetia and Vytorin. WSJ Health Blog.
Why statins decrease cardiovascular mortality but medications which "merely" lower cholesterol (like Zetia) appear to lack such benefit? One hypothesis is that statins have an antiinflammatory effect in addition to lowering LDL.
The share price of the drug manufacturer, Schering-Plough Corporation, dropped by almost 8% today.
Related:
Cholesterol Drug Has No Benefit in Trial, Makers Say. NYTimes.
3rd UPDATE: Vytorin Fails To Benefit Artery Vs. Statin Drug. CNN.com.
Lipitor Looks Better than Zocor in Retrospect. WSJ Health Blog.
Pulling Back the Curtain on Statins. Dr. Wes, 01/2008.
Health: Nothing but a number: Lifestyle changes to control cholesterol. Dr. Sidney Gottlieb, Cleveland Clinic Canada, National Post, 01/2008.
Image source:Ezetimibe, from Wikipedia, the free encyclopedia, public domain.
Updated: 01/31/2008
Dr. Nissen claimed that Lipitor 80mg "stopped plaque in its tracks" in 2004 after the REVERSAL trial. Where was the reversal? There was a non significant change in the plaque. He stated then, that LDL levels had to be cut well below guidelines to see changes in plaque. Clearly that did not happen in ENHANCE due to the high LDL levels (318 baseline, 135 post Vytorin treatment). No drug has shown plaque regression in this type of patient. They represent .2% of the population. Dr. Nissen also stated in 2004 that long term trials with large number of patients, looking at event rates, were need to determine a medications value. Your judgement and Dr. Nissen's judgement on Zetia is premature and unfounded. Perhaps he should go back and read his comments after REVERSAL. I would like to know what has changed.
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