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Study Casts Doubts on Vytorin, Zetia

Cholesterol-Lowering Drugs May Not Reduce Plaque Buildup

Schering-Plough Responds

A spokesman for Schering-Plough tells WebMD that the timing of the trial results release had nothing to do with the congressional investigation.

Lee Davies blamed the delay in presenting the findings on the complexity of interpreting the data, which included some 40,000 visual images that had to be analyzed.

Davies pointed out that the study was designed to assess plaque buildup in the arteries in a very high-risk patient population. The trial was not designed to look at outcomes such as heart attack, stroke, and death.

The trial included 720 patients with a rare genetic condition predisposing them to very high cholesterol.

During the two-year study, patients were treated with either high doses of simvastatin alone or Vytorin, which combines Zetia and simvastatin.

Vytorin was found to lower LDL "bad" cholesterol more than simvastatin alone, with patients on the combination drug showing a 58% reduction in LDL vs. a 41% drop for those on the single drug.

The side effect profile for the two treatments was similar, and was consistent with the labeling for Vytorin, Davies says.

But Vytorin users had slightly more plaque buildup in their carotid arteries, although the difference was not statistically significant and could have been due to chance.

Davies says three larger ongoing trials, involving some 20,000 patients, should answer questions about whether Zetia and Vytorin prevent more adverse events and deaths than statins alone.

He questions the reaction to the ENHANCE results, which he called a "small, academic trial."

"The implications drawn from the findings in terms of clinical use seem out of proportion to what the trial was designed to demonstrate," he says. "One should keep in mind that while statins are the first-line therapy for most people, they are not enough for many people and are not appropriate for some. There is a need for viable alternatives, and Zetia and Vytorin have proven to be very effective for lowering LDL levels."

Combined quarterly sales of Zetia and Vytorin reached $1.3 billion in the second quarter of 2007, with Vytorin sales growing by 30% and Zetia sales increasing by 21%, according to the Dow Jones news service MarketWatch.

Docs Weigh in

A statement released Tuesday afternoon by the American College of Cardiology (ACC) urged patients taking Zetia or Vytorin to remain calm in the wake of the ENHANCE findings.

The statement made it clear that ACC still considers Zetia a reasonable option for patients who cannot tolerate statin drugs or can only tolerate low-dose statins.

"There is no reason for patients to panic," the statement read. "Concerned patients using these drugs should talk to their health care professional. This is not an urgent situation and patients should never stop taking any prescribed medications without first discussing the issue with their health care professional."

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Desirable
0-199
Borderline
200-239
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240+

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Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is optimal.

Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is near optimal.

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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