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New Debate Over Vytorin and Cancer

Data Are Reassuring, but Editor of Leading Medical Journal Says Drug Can't Be Cleared
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WebMD Health News

Sept. 2, 2008 -- Recent data suggesting the cholesterol-lowering drug Vytorin ups cancer risk can't yet be dismissed, the editor of The New England Journal of Medicine says.

The worrisome cancer data come from a clinical trial called SEAS, reported today at a major European cardiology conference and simultaneously published online by The New England Journal of Medicine. But these findings come as no surprise.

That's because of a highly unusual news conference held last July. SEAS study leader Terje Pedersen, MD, PhD, announced the unexpected finding of a possible Vytorin cancer link. Then he turned the podium over to Oxford University's Richard Peto, FRS, who said his independent analysis of two ongoing Vytorin studies revealed no credible evidence linking Vytorin to cancer risk.

Not so fast, says an editorial by Jeffrey M. Drazen, MD, editor-in-chief of The New England Journal of Medicine, and colleagues. The editorial says we simply can't assume -- as Peto asserts -- that the Vytorin cancer link is simply a chance finding.

"What these data show is there is a potential for a small risk for increased cancer and cancer deaths from Vytorin," Drazen tells WebMD. "Until clinical trials are completed, no one can say this drug is cleared -- and no one can say it causes cancer. We have to live with this uncertainty."

Assessing Cancer Risks

If there is a risk, it isn't very large, says Richard H. Karas, MD, PhD, director of preventive cardiology at Tufts Medical Center in Boston. Karas was not involved in the Pedersen or Peto studies, but he reviewed the published reports for WebMD.

In the SEAS trial, patients on placebo had a 0.5% annual risk of getting cancer. This risk doubled in patients on Vytorin -- but only to 0.9% a year. This risk was even lower in the two ongoing trials: 0.4% per year in control patients, and 0.5% per year in patients taking Vytorin.

But Peto tells WebMD that this risk -- if it were real -- would be frighteningly large. That's because it appeared in a very short time, in just the first years after patients began taking Vytorin. A real doubling of cancer risk in such a short time, he says, would make Vytorin one of the most dangerous carcinogens ever known.

But that, Peto says, is preposterous. When his team looked at the data from the IMPROVE-IT and SHARP trial, they found no increase in cancer over time -- which one would expect from a potent cancer-causing agent. Moreover, they found no increase in any specific kind of cancer.

"If this stuff was 100 times as dangerous as cigarette smoke, as the SEAS finding suggests, you would expect to see an increase over time in the hazard. And we don't," Peto tells WebMD. "And if you had no effect, you would expect the excess cases to be distributed evenly over time, and they are. So we do not get any increase over time in risk, either in cancer incidence or in death from cancer."

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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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