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Print ArticleCholesterol Management Health Center
Vytorin’s Shortcoming a Boon for Statins
March 31, 2008 (Chicago) -- When it comes to cholesterol lowering, it's time to return to the basics -- statins.
So concludes an expert panel that analyzed the full results of the controversial study of the newer anti-cholesterol pill Vytorin.
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Early findings from the study showed that Vytorin, which combines the unique cholesterol drug Zetia with the older, cheaper statin drug Zocor, was no better than Zocor alone at slowing plaque buildup in high-risk patients.
The full results, released at the American College of Cardiology (ACC) meeting and published online by The New England Journal of Medicine, not only confirmed those findings, but extended them.
"There is absolutely no subgroup [of patients] that either benefited more or had more harm [from Vytorin treatment] than the mean, which is basically zero," says study researcher John Kastelein, MD, of the Academic Medical Center in Amsterdam, Netherlands.
The Vytorin Controversy
Vytorin has been embroiled in controversy since the early findings were revealed in January in a news release issued by drug companies Merck and Schering-Plough, which jointly market Vytorin and Zetia.
Two congressional panels launched investigations into why there was a two-year delay between when the study ended and the release of the results. Critics also accused the companies of attempting to change the endpoints of the study, known as the ENHANCE trial, in an effort to present the results in a more favorable light.
Statins are one of the most widely prescribed drugs used in the U.S. to treat high cholesterol. They include medications such as Zocor, Pravachol, Mevacor, Lipitor, Lescol, and Crestor. They work by actually blocking the body's ability to produce cholesterol.
In contrast, Zetia works only by blocking the absorption of cholesterol in the body.
Vytorin Lowers LDL but Doesn’t Slow Plaque Buildup
It's not that Vytorin doesn't lower bad LDL cholesterol -- it does, by about 50 points in the study. It also reduced blood levels of a marker of inflammation known as C-reactive protein that's been implicated in heart disease.
What Vytorin didn't do is meet the study goal of reducing plaque buildup in the carotid arteries that run through both sides of the neck to the brain. And it hasn't been shown to reduce the risk of heart attack, stroke, or death, although that was not a goal of this study.
In contrast, statins have proven benefit in improving patient outcomes, says past ACC president Steven E. Nissen, chairman of the department of cardiovascular medicine at Cleveland Clinic.
"We know that they reduce risks," he tells WebMD.
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Research shows high cholesterol can lead to strokes for women in their 50's and even younger.
