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Vytorin not linked to cancer in other trials: doctor


http://www.therapeuticsdaily.com/news/article.cfm?contenttype=sentryarticle&contentvalue=1812945&channelID=28
Reuters Health - Jul. 21, 2008

NEW YORK (Reuters) - The Vytorin cholesterol fighter sold by Merck & Co and Schering-Plough has not been linked to cancer or cancer deaths in two large ongoing studies of the medicine, an epidemiologist said on Monday during a medical meeting in London.

"There is no overall credible evidence of an increase in cancer" from the two big studies, Sir Richard Peto, professor of medical statistics and epidemiology at the University of Oxford, said at a meeting where results of an unrelated smaller Vytorin trial suggested a possible cancer risk with Vytorin.

Peto said the two far-larger ongoing studies where cancer has not been associated with Vytorin are IMPROVE-IT, designed to assess overall cardiovascular benefits and risks of the medicine, and SHARP, designed to assess possible benefits of the drug to patients with chronic kidney disease.

"We should not be diverted by fears of cancer" with Vytorin, Peto said, based upon trends seen in the two larger studies involving about 20,000 patients.

By contrast, in the 1,873-patient trial described on Monday, called SEAS, a higher number of patients with thickened aortic valves receiving Vytorin developed cancer or died of cancer than those receiving placebos.
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Vytorin data on cancer "errant": U.S. heart group president-elect

Reuters Health - Jul. 21, 2008

WASHINGTON (Reuters) - The American Heart Association's president-elect on Monday said the latest data on cancer deaths reported in Schering Plough Corp and Merck & Co's Vytorin cholesterol drug is "an errant signal for now."

Clyde Yancy, president-elect of the American Heart Association, commented on the findings of a closely watched heart study released earlier that found the drug combination failed to meet its main goal of improving cardiovascular outcomes.

There were numerically more cancer deaths in the group of patients treated with Vytorin compared with those on a placebo, although the difference could have been statistically due to chance.

"One has to surmise that the signal seen in the (current) trial was really just an errant signal for now," Yancy said, noting researchers checked two larger studies and found no similar signal.

The suggestion of cancer spooked some investors and lead to about a 15 percent drop in shares of Schering-Plough, which relies heavily on the drug, for its revenue.

Prior to the data, shares were down about 8 percent on the NYSE.

"We need to stay watchful. Certainly the signal was not strong enough that it should warrant a change in behavior," he said.