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Study: No proof of Vytorin link to cancer
Published in Saudi Press Agency on 02 - 09 - 2008


New research into a possible link
between a cholesterol-reducing drug and cancer concluded
there was no proof to establish a connection, but other
doctors warned that it should be used more carefully, reported ap.
In a paper published Tuesday by the New England Journal of
Medicine, Terje Pedersen and colleagues found that cancer
occurred more frequently in patients taking Vytorin, a
combination of Merck's Zocor and Schering-Plough's Zetia,
than in people on a placebo pill. But that study was too
small to stand as proof of a real link.
In a larger analysis of data considering the possible link
between Vytorin and cancer, also published in the New
England Journal of Medicine, epidemiologists said there was
no evidence implicating Vytorin, which millions of people
take worldwide.
The two papers were also presented at a meeting of the
European Society of Cardiology in Munich.
But not all doctors were convinced that Vytorin is
risk-free.
«I think the jury is still out as to whether there's a
cancer signal,» said Dr. Gordon Tomaselli, chief of
cardiology at Johns Hopkins Hospital, and spokesman for the
American Heart Association. Tomaselli was not connected to
the research.
The trial's preliminary results were announced ahead of
schedule in July, when investigators discovered a higher
incidence of cancer in patients on Vytorin.
At that point, Sir Richard Peto, a cancer epidemiologist,
rushed to crunch numbers from Pedersen's study with two
bigger Vytorin studies to see if the drug might be linked
to cancer.
«I don't think there is any evidence of hazard here,»
Peto said. Peto's group at Oxford University is carrying
out another trial on Vytorin funded by Merck & Co. and
Schering-Plough Corp. They found that there was a lower
incidence of cancer among people on Vytorin, but that the
death rate was higher.
Pedersen's original trial aimed to determine whether
Vytorin might help prevent problems with the heart valve.
Vytorin lowers cholesterol, which doctors thought might
also help reduce the risk of heart valve problems, which
affect millions of people worldwide.
Problems occur when the valve becomes blocked or stiff,
compromising its ability to pump oxygen-rich blood
throughout the body.
In the trial, Vytorin was no better at reducing the risk
of heart problems than were the fake pills people took.
They followed 1,873 patients in Europe and the United
States. Patients were either given Vytorin or a placebo. Of
patients on Vytorin, 105 developed cancer, compared with 70
among those on placebo.
Some doctors suggested that the hypothesis behind the
trial was mistaken, and that heart valve problems can only
be solved with surgery, not with medication.
But they said the drug is still useful for people who need
their cholesterol lowered _ if other drugs do not work.
«If I was on this medication and it was the only way to
get my cholesterol down, I would not change my therapy
based on this,» said Dr. Douglas Weaver, president of the
American College of Cardiology. The College has been asked
by the U.S. Senate to account for the money it accepts from
pharmaceutical companies, including Merck.
The New England Journal of Medicine editors had a staff
statistician look at combined cancer deaths from all three
Vytorin studies. They say the extra risk «should not be
assumed to be a chance finding» until more information is
in. Doctors and patients now are left with «uncertainty»
about the safety and effectiveness of the drug, the
journal's editors concluded.
With other options available for heart patients, some
doctors said there was no obvious reason to take Vytorin.
«There's no proof that this combination is working,» said
Dr. Christer Hoglund, a cardiologist at Sweden's Karolinska
Institute.
«We don't know that this drug is bad, but we don't know
that it's any good either.»


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