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 The panel evaluated data from an 18,000-patient trial known as
Improve-It whose results showed that the combination treatment known
as Vytorin, comprising Zetia and an older cholesterol-lowering drug,
simvastatin, reduced the rates of heart attack, stroke and death
compared with simvastatin alone.
But the panelists voted 10-5 against allowing Merck to make the
claim, saying they were not convinced the benefit was clinically
meaningful, especially since some patient data was missing.
"The benefit here is small," said Dr. Milton Packer, distinguished
scholar in cardiovascular science at Baylor University Medical
Center. "It is not robust. You blink and you miss it, and you wonder
if you care or don’t care."
The FDA is not obliged to follow the advice of its advisory panels
but typically does so.
"Today's discussion is one step in the regulatory process," Dr.
Daniel Bloomfield, vice president of cardiovascular disease at Merck
Research Laboratories, said in a statement. He said the company
would continue to work with the FDA "so that they can complete the
review" of its request for new indications for Vytorin and Zetia.
"We believe Improve-It showed that ezetimibe in combination with a
statin offers a significant benefit to high-risk patients with
coronary heart disease," he said. Zetia is Merck's brand name for
ezetimibe.
In the Improve-It study, Vytorin reduced the risk of heart attacks,
strokes and other heart problems by 6.4 percent compared with
patients who took simvastatin alone, meeting the main goal of the
trial.
Simvastatin is sold by Merck under the brand name Zocor.
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Some panelists said that result should have been enough to support
approval.
Dr. William Hiatt, a professor at the University of Colorado School
of Medicine, said the FDA's role is to determine whether the results
of a trial are statistically significant. Other organizations, he
said, such as payors, typically decide whether they are clinically
meaningful.
Vytorin and Zetia are both currently approved to reduce "bad" LDL
cholesterol. Vytorin has long been used in the hope it reduces
cardiovascular events, but Merck has not been allowed make those
claims in its marketing material because the FDA has not approved it
for that use.
(Reporting by Toni Clarke in Washington; Editing by Bernard Orr and
Leslie Adler)
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