Vytorin Risks Debated in Medical Journal

To get a firmer grip on any possible risk, the Clinical Trial Service Unit and Epidemiological Studies Unit at Oxford University looked at cancer mortality data from the SEAS and interim data from two ongoing trials, dubbed SHARP and IMPROVE-IT. When combined, there were 134 patient deaths in the Vytorin arms of the studies, vs. 92 in the control groups, but the result was not statistically significant, according to the results which also were reported in the current issue of the New England Journal of Medicine.

"The Oxford researchers believe that this finding is due entirely to the play of chance rather than to a true increase in cancer mortality," write the authors of an editorial titled "Ezetimibe and Cancer -- An Uncertain Association," appearing in the same issue. "They argue that an increase in the risk of cancer death, if real, should be paralleled by an increase in the risk of cancer incidence, which was not found in the combined analysis, and that there is no plausible mechanism for such an effect."

But, the editorial's authors say it is still appropriate to raise a note of caution. They note that Zetia interferes with the gastrointestinal absorption not only of cholesterol, but also of other molecular entities that could conceivably affect the growth of cancer cells. Thus, we shouldn't assume the increase in cancer deaths with Zetia to be a chance finding until we have more data, they say.

Schering Plough and Merck have been reeling since the ENHANCE study showed that Vytorin lowered "bad" cholesterol, did no more to reduce the plaque that leads to heart attacks than a statin alone.