07/22/2008 (1:39 am)
Vytorin fails to meet main goal of heart study
The cholesterol fighter Vytorin sold by Merck & Co Inc (MRK.N: Quote, Profile, Research, Stock Buzz) and Schering-Plough Corp (SGP.N: Quote, Profile, Research, Stock Buzz) 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 freecreditscore. 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.
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