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Vytorin’s Shortcoming a Boon for Statins

Disappointing Results of Vytorin Study Lead Doctors to Call for Return to Proven Cholesterol-Lowering Drugs
By
WebMD Health News
Reviewed by Louise Chang, MD

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.

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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Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is borderline high. If your LDL goes higher, your total cholesterol level could become Borderline High. Consider reducing the amount of foods you eat with saturated fats and increasing physical activity. If you get more exercise, your level of "good" HDL cholesterol may increase, which could also help to keep your levels of LDL and total cholesterol in check.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL. The HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is Very High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL because the HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is Borderline High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. But your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol is High, but your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol is High, but your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center.

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is Borderline High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe medication, such as statins. Following medication, dietary, and exercise instructions should result in improvements.

Your total cholesterol level is High, and your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe statins or other cholesterol-lowering medications.

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