Fla. — For patients taking a statin to control high cholesterol,
adding an old standby drug, niacin, was
superior in reducing buildup in the carotid artery to adding Zetia, a newer
drug that reduces bad cholesterol, according to a new study.
The results of the study,
published in The New England Journal
of Medicine, were presented here Sunday night at an annual meeting of the American Heart
The study has been
a polarizing topic here and has also attracted the attention of a powerful
senator who has been investigating the conduct of two drug makers, Merck and
Schering-Plough, in relation to their sales and marketing of Zetia and a
combination cholesterol drug, Vytorin, which includes Zetia. The drug makers
merged this month.
The small study,
with only 208 patients, has attracted outsize attention because the researchers
did a head-to-head comparison of niacin and Zetia, which has been heavily
The Food and
Drug Administration approved Zetia in 2002 to lower bad cholesterol, a risk
factor for heart disease. But the drug has not yet proved to have a longer-term
clinical benefit in reducing heart attacks and deaths. Merck, the maker of the
drug, is conducting a clinical trial on that issue involving up to 18,000
like Lipitor have proved
in studies to significantly lower the risk of heart attack.
here hailed the study as an indication that the popularity of Zetia and Vytorin,
which had combined sales last year of about $4.6 billion, has far outstripped
their evidence of a concrete benefit on heart health. Other doctors here
dismissed the study because it did not directly measure the drugs’ effects on
reducing heart attacks.
study has the potential to make big waves in the use of cholesterol drugs.
“It will certainly
strengthen the idea that, after you give a statin, the weight of the evidence
is that, as a second agent, you should give niacin,” said Dr. Roger S.
Blumenthal, a professor of medicine at the Johns Hopkins University
“That is the implication of the study.”
But Dr. Peter S.
Kim, the president of Merck Research Laboratories, said Sunday in an interview
that the study was limited because it did not compare the groups of patients
taking a statin and a second drug to a placebo group. Furthermore, he said, a
drug’s ability to improve artery-wall thickness has not been proved to
automatically correlate with a reduction in heart attacks.
Zetia, he said,
lowers bad cholesterol and lowering bad cholesterol is a known good.
The study results
“should be compared to the overwhelming body of evidence that lowering LDL
cholesterol is an important thing to do to
improve cardiovascular health,” Dr. Kim said.
The study randomly
assigned patients who were taking a statin and who had heart disease or a risk
of heart disease to additionally take either Zetia or Niaspan.
Statins are a class
of drug which lowers LDL, known as
bad cholesterol because it can cause arterial thickening and lead to heart
problems. The drugs work by inhibiting the production of cholesterol in the
inhibits the absorption of cholesterol in the intestines, lowers bad
Niaspan is a
prescription extended-release form of niacin, not the over-the-counter vitamin.
Niacin increases HDL, known as “good
cholesterol.” Niaspan is made by Abbott Laboratories,
which financed the study.
Over the course of
the 14-month study, the bad cholesterol of the patients on Zetia decreased by
19.2 percent, but the patients’ arterial wall thickness stayed the same, the
study said. In the niacin group, good cholesterol
increased by 18.4 percent and the carotid wall thickness decreased.
By itself, the
study does not have major significance, said Dr. James H. Stein, a professor at
the University of Wisconsin
medical school. But
taken in the context of more than 30 years of research on and use of niacin, he
said, the study adds to the weight of evidence that it can be a great benefit
to patients with heart disease, he said. “Compare that to Zetia
where there is not a shred of evidence that it does anything good for blood
vessels or heart disease,” Dr. Stein said.
On Friday, Senator Charles E. Grassley,
Republican of Iowa, wrote to the Department of Health and
Human Services, asking its director, Kathleen Sebelius, what
action she intended to take in light of the study results. Mr. Grassley sits on
the Senate Finance Committee which has jurisdiction over Medicare and its
drug spending. In 2006 and 2007, the drug makers made more than $300 million
through Medicare Part D in sales of Vytorin,
a drug that combines Zetia and a statin, Mr. Grassley wrote.
In response to a
query from a reporter, a Merck spokesman said the small trial did not change
the company’s belief in the demonstrated ability of Zetia and Vytorin to reduce