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FDA to Explore Possible Vytorin-Cancer Link

Experts, FDA Advise Patients to Talk to Their Doctors
By
WebMD Health News

vytorin_cancer_link.jpg

Aug. 21, 2008 -- The FDA is reviewing the safety of Vytorin, which combines the cholesterol-lowering drugs Zocor and Zetia, after a clinical trial linked the drug to cancer risk.

In the trial, called SEAS, 4.1% of patients taking Vytorin died of some form of cancer -- more than the 2.5% of patients who received an inactive placebo.

A recent statement issued by the study investigators noted that these differences "are small and could have occurred as a result of chance."

While other clinical trial data do not indicate an increase in cancer risk, the FDA is alerting doctors and patients now while it awaits further data from the manufacturers, which they should receive in about three months. After that point, the FDA says it'll take an additional six months for a complete evaluation of the data.

Based on all available data on the link between Vytorin and cancer risk, the FDA says patients should not stop taking Vytorin or any other cholesterol drug.

The American Heart Association says the same thing, recommending that patients taking prescribed cholesterol-lowering drugs should not stop taking them without talking with their doctor. Patients who stop taking prescribed cholesterol medications increase their risk of having a heart attack or other cardiovascular event.

Vytorin is jointly marketed by Merck and Schering-Plough. Schering-Plough tells WebMD it is cooperating with the FDA.

"We believe that the findings in SEAS on cancer are likely to be an anomaly," Schering-Plough's Mary-Fran Faraji tells WebMD. "We don't believe, in light of all the data, that there's an association [of cancer] with Vytorin."

A recent study reviewing cancer risk from Zocor and other cholesterol-lowering statin drugs found no link between statin use and cancer, contradicting its own preliminary findings that did suggest such a link.

"When you put all of the information together, there is no evidence that statins increase the risk of cancer," researcher Richard Karas, MD, says in a news release in response to those study findings.

In addition, interim data from two ongoing trials of Vytorin show no increased risk of cancer in patients receiving the drug. The first of these trials (the SHARP study) won't be finished until 2010; the second (the IMPROVE-IT study) will end in 2012.

In a separate development, the U.S. House Energy and Commerce Committee is investigating the SEAS study and today asked Merck and Schering-Plough for details.

Faraji says both companies are cooperating with that investigation.

Earlier this year, Vytorin suffered another setback when a clinical trial showed that Vytorin did not reduce artery-clogging plaque better than Zocor alone.

WebMD's Miranda Hitti contributed to this report.

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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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