NEW YORK (Reuters Health) - Contrary to a recent report, findings from a large-scale study suggest that the cholesterol-lowering drug Zetia (also known by the generic name, ezetimibe) does not increase the risk of cancer. This also holds true for Vytorin, which combines ezetimibe with simvastatin, another cholesterol-lowering agent.

In a trial reported last year, use of Vytorin was associated with a cancer rate of 11 percent, significantly higher than the 8 percent rate seen in patients who were given an inactive "placebo." This finding caused widespread concern, but data from studies reflecting how the drug is used in the "real world," outside of strict controlled clinical trial, were lacking.

The current "real-world examination shows no increased risk to patients taking (Zetia or Vytorin) to lower their (cholesterol) levels -- an issue that sparked many policy and healthy safety conversations," study co-author Dr. Richard H. Karas, from Tufts University School of Medicine, Boston, said in a statement.

The findings stem from an analysis of all cancer reports filed with the US Food and Drug Administration from July 2004 to March 2008 among users of Zetia and Vytorin. The cancer rates documented by these reports where then compared with rates in users of other cholesterol-lowering drugs.

A total of 559 million prescriptions were written during the 4-year period for all of the drugs studied and 2334 cancer reports were filed, according to the report in the Journal of Clinical Lipidology.

The number of cancer reports per one million Zetia prescriptions was 2.9, and for Vytorin prescriptions it was 1.3. For the other drugs, the numbers ranged from 3.1 to 5.1.

Roughly 2.0 percent of all Zetia or Vytorin side effect reports were cancer related. For the other drugs, this percentage ranged from 1.3 to 3.9 percent.

Taken together, these findings suggest that the risk of cancer with use of Zetia or Vytorin is no greater than the risk seen with other cholesterol-lowering drugs.

"These data will hopefully return the conversation between physicians and patients back toward the most pressing public health risk in America -- unmanaged high (LDL 'bad' cholesterol) that can result in heart disease or stroke -- the nation's number 1 and number 3 killers," Karas emphasized.

SOURCE: Journal of Clinical Lipidology, April 2009.

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