Vytorin fails to meet main goal of heart study

NEW YORK (Reuters) - The cholesterol fighter Vytorin sold by Merck & Co Inc and Schering-Plough Corp failed to meet the main goal of improving outcomes better than a placebo in a closely-watched heart study, according to data presented on Monday.

The data, which did contain some positive news about the drug, did little to remove the cloud hanging over Vytorin since January from a previous study and the shares of both companies fell sharply. Vytorin use has declined since that study failed to show the combination drug worked any better in cutting arterial plaque than the cheaper generic statin that is one of its two components.

Slightly higher incidents of cancer deaths were seen in those taking the drug -- 39 versus 23 on placebo -- in the new study, although the lead researcher said those could have occurred as a result of chance.

No significant difference in the study's composite heart goals was seen between patients who received Vytorin and those who took a placebo, according to data presented in London by its primary researcher, Dr. Terje Pedersen of Ulleval University Hospital in Oslo, Norway.

"The study seems to reinforce that we really do not know the effect of this drug on patients, whether it provides an important benefit or even a harm," said Harlan Krumholz, a prominent researcher from Yale University who has closely watched Vytorin developments.

"More than ever we need the results of a large trial to guide us about how best to use the drug," said Krumholz, adding: "In the meantime, patients and doctors should realize that there is substantial uncertainty about the net effect of the drug, even as it lowers cholesterol levels."

Such a trial is underway but the results are years away.

Researchers played down the cancer data, saying much larger studies of Vytorin have not showed increased cancer risk.

"There is no overall credible evidence of an increase in cancer," said Sir Richard Peto, professor of medical statistics and epidemiology at the University of Oxford, who reviewed the data. "We should not be diverted (from using Vytorin) by fears of cancer."

The Food and Drug Administration said it plans to review the new Vytorin data.

The primary composite goals of the study of patients with irregular thickening of the main valve to the aorta were broken into two sets of secondary goals and Vytorin was superior on one of those measures, researchers said.

Vytorin was significantly better than placebo in reducing atherosclerotic events, defined as nonfatal heart attacks, need for coronary artery bypass surgery or artery-clearing procedures, hospitalization due to chest pain and strokes.

The drug was no better than placebo on the other secondary measure of reducing aortic valve disease events -- the need for surgical valve replacement, hospitalization because of heart failure and cardiovascular death.

"Overall it looks positive. They did decrease atherosclerotic events, which is sort of what everyone expected," said Natixis Bleichroeder analyst Jon LeCroy.

He said cancer fears should be allayed by results of larger, previous studies.

"But we've seen with drugs in the past any time cancer gets tagged on them sometimes the prescriptions can come off a little bit," he added.

Vytorin did lower bad LDL cholesterol by 61 percent throughout the study.

The 1,873-patient trial was designed to determine whether aggressive cholesterol lowering can lessen the need for surgical replacement of aortic valves, reduce cardiac death and reduce cardiovascular events, including heart attacks, in people suffering from aortic stenosis.

"The study has given a clear-cut answer whether lipid lowering will influence the cause of aortic stenosis and we can conclude it does not," Pedersen said.

But he noted that Vytorin did offer some benefits in reducing risk of coronary artery disease in the study.

Linda Bannister, an analyst for Edward Jones, said it would have been a positive surprise had Vytorin met the main goal of the latest study, called SEAS.

"The concern is how this is going to be portrayed and perceived and is it just going to be another issue where there is a lot of negative publicity surrounding the drug," she said.

The earlier failed trial called Enhance led to widespread unfavorable publicity and subsequent recommendations by researchers that patients first try other cholesterol fighters before opting for Vytorin.

Merck shares closed down $2.35, or 6.2 percent, at $35.33, up from an intraday low of $34.77, while Schering-Plough shares closed down $2.49, or 11.6 percent, at $18.95 after falling as low as $17.82 on the New York Stock Exchange.

(Additional reporting by Lewis Krauskopf, Deepa Seetharaman, Michael Kahn, Kim Dixon and Julie Steenhuysen; Editing by Andre Grenon)