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The decision on Vytorin has yet
to be taken, as health officials continue discussions on the drug’s
effectiveness, but a final answer is expected to be given after the final trial
results are out. The issue came to the attention of specialists earlier this
month, when some trial tests have proven that the medication had no beneficial
effect on patients.
Dr. John Jenkins, director of
the FDA’s Office of New Drugs, Center for Drug Evaluation and Research,
explained in a teleconference: “We have not yet received a final study report
and can’t explain why Vytorin didn’t lead to lesser amounts of plaque compared
to patients treated with simvastatin alone.”
The latest tests on Vytorin,
which a combination of two drugs, Zetia (Ezetimibe), an anti-hyperlipidemic
medication meant to decrease cholesterol absorbtion in the intestine, and
marketed by Merck and Schering-Plough, and Zocor (Simvastatin), a statin used
to control high cholesterol levels and prevent cardiovascular disease, have
shown that instead of reducing the plaques of fat in arteries that are
responsible for heart problems, they’ve doubled in size.
“Once we receive the final study
report, we estimate it will take as long as six months for us to fully evaluate
the results of the Enhance study," Dr. Jenkins said. "And we will be
considering whether any further action is warranted in regard to Zetia or
Vytorin, and also whether this study has any impact on our approach to the
approval of lipid-lowering drugs."
Millions of people are taking
cholesterol lowering drugs in order to prevent cardiovascular complications. The
decision has been delayed so far, but FDA promised it will make one as soon as
possible. Both Zetia and Vytorin
significantly increased the incomes of the two companies, Merck and
Shering-Plough, and so the decision will be of most importance to them and the
patients who have been recommended Vytorin.
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