- ORLANDO, Fla. (Reuters) -
Pfizer Inc.'s top-selling cholesterol drug Lipitor can halt, not just slow,
the potentially fatal buildup of plaque in clogged arteries, researchers
said on Wednesday.
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- The study is the first solid evidence that a prescription
drug can stop the build-up of new plaque and even reverse it in some patients.
A handful of drugs now available slow the buildup of new plaque, or atherosclerosis,
in coronary arteries.
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- "We were excited we could find a regimen, although
an intensive one, that could stop the disease in its tracks," said
the lead researcher, Dr. Steven Nissen of the Cleveland Clinic in Ohio.
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- Shares of Pfizer, the world's biggest drug company, were
up over 2 percent on the news.
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- The results of the 18-month clinical trial, presented
at an annual meeting of the American Heart Association in Orlando, showed
Lipitor halted the progression of plaque and cleared 0.4 percent of existing
build-up among patients with clogged arteries.
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- That compared with a 2.7 percent increase in plaque for
patients on a lower dose of Bristol-Myers Squibb Co.'s competing drug Pravachol.
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- Lipitor is the world's top-selling drug with annual sales
approaching $10 billion, and Pfizer will use the data on atherosclerosis
to boost its marketing pitch for the drug.
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- The Pfizer drug is a more potent drug than Pravachol
among the statin class of drugs that reduce low-density lipoproteins, or
"bad" cholesterol, in the blood.
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- The 500-patient clinical trial, sponsored by Pfizer,
set out to compare a more aggressive statin regimen of 80 milligrams of
Lipitor daily with a moderate therapy of 40 milligrams of Pravachol, Nissen
said.
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- Nissen said he was surprised to see that even when patients
achieved low LDL levels on Pravachol, their disease still progressed more
than it did for the Lipitor patients. This suggested to Nissen that massive
LDL reduction, though important, is not the only factor at play, he said.
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- The trial also showed Lipitor reduced levels of a dangerous
inflammatory protein called C-Reactive Protein by 36.4 percent, compared
with a 5.2 percent reduction among Pravachol patients.
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- That may explain the disparity between the two drugs
in halting plaque build-up, Nissen said.
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- Another factor in stopping plaque build-up may be raised
levels of HDL or "good" cholesterol. An experimental HDL-raising
drug from Esperion Therapeutics Inc. reduced fatty artery deposits by 4.2
percent in a small clinical trial reported earlier this month.
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- Nissen said it would still be up to individual physicians
to decide whether to prescribe a high-dose therapy, such as 80 milligrams
of Lipitor, for their patients with atherosclerosis, which is the leading
cause of death from heart attack and stroke.
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- "I will let my colleagues look at the findings and
make their own minds up," he said. "I think there are some tough
decisions that will have to be made."
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- Deutsche Bank analyst Barbara Ryan said the findings
"will force the market increasingly toward the most significant reduction
that can be safely achieved for that patient."
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- While Lipitor showed only "slight" plaque reductions,
"it is reducing rather than just halting the progression. And what
you're seeing with Pravachol at 40 milligrams is they're not even doing
that," Ryan said.
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- Bristol-Myers is sponsoring its own clinical trial comparing
40 milligrams of Pravachol with 80 milligrams of Lipitor in an attempt
to prove that standard amounts of LDL reduction could be sufficient to
prevent major heart problems.
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- The goal of the trial is to compare the two drugs in
preventing secondary heart attacks, strokes and other problems among patients
who have already been hospitalized for an acute heart incident and sent
home, said Dr. Christopher Cannon of Brigham and Women's Hospital of Boston.
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- Shares of Pfizer were up 74 cents, or 2.3 percent, at
$32.39, while shares of Bristol-Myers were up 36 cents, or 1.4 percent,
at $25.34. (Additional reporting by Bill Berkrot and Ransdell Pierson)
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