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Vytorin Study to Get FDA Review

Medical Mystery: Why Did Vytorin Cut Cholesterol but Not Plaque?
By
WebMD Health News
Reviewed by Louise Chang, MD

Jan. 25, 2008 -- The FDA says it will explore the medical mystery of why Vytorin cuts cholesterol but doesn't seem to reduce plaque in the arteries.

Vytorin is a combination of two different types of cholesterol-lowering drugs: Zetia, which blocks cholesterol absorption in the gut, and Zocor, one of the statin drugs that slows cholesterol production. Other statins include Crestor, Lescol, Lipitor, Mevacor, and Pravachol.

Zetia increases the cholesterol-lowering effects of statins. But preliminary results of a study by the companies that make and sell Vytorin were surprising.

As expected, patients who took Vytorin had lower levels of bad LDL cholesterol than did patients who took Zocor alone. But Vytorin patients did not have any less plaque in their arteries than those who took Zocor. In fact, they had slightly more.

That mystery is troubling to the FDA. Because lower LDL cholesterol is strongly linked to lower risk of heart attacks and stroke, the FDA approves drugs that can safely lower cholesterol. Even so, drugmakers must prove their products actually prevent heart disease before they can say this on the drugs' labels.

So why didn't Vytorin's superior ability to cut LDL cholesterol translate into superior ability to cut plaque? That's what the FDA wants to know, John Jenkins, MD, director of the FDA's Office of New Drugs, said in a news conference.

"We have not received the final study report and cannot explain why the lower LDL did not lead to lower amounts of plaque," Jenkins said. "Once we fully review the data, we may consider whether any further action is required, and whether this has any effect on our way of approving cholesterol-lowering drugs."

Jenkins quickly added that the FDA does not expect to change its longstanding policy of approving drugs that safely lower LDL cholesterol. All of the statin drugs were initially approved on this basis. All but Crestor -- a newer statin that is completing such studies -- eventually were shown to reduce the risk of heart attack and stroke.

Jenkins said it would take the drug companies Merck and Schering-Plough -- which jointly market Vytorin -- two or three months to get the study data to the FDA. After that, he said, it will take the FDA up to six months to review the data.

"When we talk about the full study report, we are talking about thousands of pages of documents and analyses. This is not a three- or four-page journal article. ... So if we get it in a couple of months, we'll be done in no more than six months, and it may well be sooner."

Reporters pressed Jenkins on why, since the study was completed in April 2006, it is taking so long to get the data to the FDA -- and why preliminary results were reported only last week.

"As a general rule, after the last patient visits the clinic and the trial period is over, a lot of work goes on to collect information," Jenkins said. "In this case, a central reading committee had to read the plaque images. That can take some time. Also, there is a question of the priority of how the company assigns its resources to get the work done. It is not unusual for it to take months, or even longer than months, to do all the data cleanup you need to say you are ready."

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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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