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FDA: Vytorin Unlikely to Up Cancer Risk

Latest Statement From FDA Follows a Review of Studies on the Cholesterol-Lowering Drug
By
WebMD Health News
Reviewed by Louise Chang, MD

Dec. 22, 2009 -- The FDA says a connection between the cholesterol-lowering drug Vytorin and cancer risk is unlikely, but shouldn't be ruled out.

Vytorin is a combination of two cholesterol-lowering drugs, Zocor, from Merck, and Zetia, from Merck and Schering-Plough.

The FDA said in August 2008 that it was investigating a report from a clinical trial of a potential link between Vytorin and an increased incidence of cancer.

The agency said today it issued the new statement after reviewing data from that trial (known as the SEAS trial) and two ongoing large clinical trials.

The SEAS trial involved 1,873 patients with a narrowed or obstructed aortic valve of the heart; its goal was to determine if lowering the amount of LDL "bad" cholesterol with Vytorin would reduce the number of major adverse cardiovascular events. The FDA said today it found no lower overall cardiovascular risk with patients on Vytorin.

The preliminary findings of the two ongoing trials known as the SHARP trial and IMPROVE-IT trial, which include over 20,000 participants, showed no increased risk of cancer. Although there were more deaths in the Vytorin groups, the finding wasn't statistically significant. The FDA notes that when the SHARP and IMPROVE-IT trials are completed, it will further analyze the data for cancer risk.

The agency said that while it's unlikely there's an association between Vytorin or Zetia and cancer, "at this time an association cannot be definitively ruled out."

The FDA said it is not advising doctors or consumers to stop using any of the three medications but will continue to evaluate the clinical benefits and potential risks of Vytorin and Zetia compared to other cholesterol-lowering drugs it has approved.

The FDA said it issued today's update because:

  • Animal studies have not found an association between Zetia and an increased incidence of cancer.
  • A large body of data indicates that Zocor is not associated with increased cancer risk, but that long-term data on Zetia is not sufficient to definitely rule out a cancer risk.
  • Risk of cancer in the SEAS trial did not increase consistently over time with longer use of Vytorin, which would have been expected of a drug that caused cancer or promoted the growth of pre-existing cancers.
  • The reported increase in cancer and cancer-related deaths in the SEAS trial was the result of combining a wide variety of cancer types together, making it "biologically less likely that a single drug" increases the risk of a wide variety of cancer types.
  • When the SEAS trial results were compared with data from the two other large studies, no consistent pattern showed up of increased cancer risk among people being treated with Vytorin.
  • The SEAS study wasn't designed to evaluate cancer risk but instead was performed after the fact and without necessary statistical corrections.

The FDA says the SHARP and IMPROVE-IT trials will provide more information in the future to further assess cancer risk with Zocor and Zetia. The SHARP trial is expected to end in 2010 and the IMPROVE-IT study in 2012.

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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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