News Release by Pfizer
Pfizer's Lipitor Shown to Stop Progression
of Plaque Build-Up In Arteries, New Study Shows
First Head-To-Head Study That Shows Lipitor
More Effective Than Pravachol in Reducing Progression of Coronary
Atherosclerosis
ORLANDO, FL, Nov.
12, 2003 -- Patients taking Pfizer Incs
cholesterol-lowering medicine Lipitor (atorvastatin calcium) experienced
a significant reduction in the progression of atherosclerosis, or
hardening of the arteries, compared to patients who received Pravachol (pravastatin),
according to new data presented today at the annual meeting of the
American Heart Association.
The Reversing Atherosclerosis with
Aggressive Lipid Lowering (REVERSAL) study followed 502 patients, who
were diagnosed with coronary heart disease and required cardiac
catheterization, or angiograms. Patients in the 18-month study had at
least one arterial vessel with 20 percent or more constriction due to
plaque build up. The study compared the effectiveness of Lipitor (80
mg/day) versus Pravachol (40 mg/day) in reducing plaque build-up.
Lipitor-treated patients experienced a median 0.4% reduction in total
plaque volume, defined as all of the plaque present within a segment of
a single arterywhile patients who received Pravachol showed a
significant increase in total plaque volume (2.7% median).
"These results clearly show that
aggressively lowering cholesterol levels with atorvastatin calcium
stopped the progression of atherosclerosis," said Dr. Steve Nissen,
Medical Director of the Cleveland Clinic Cardiovascular Coordinating
Center and Principal Investigator of the REVERSAL study. "This study
further demonstrates the benefits of aggressively managing cholesterol
levels to reduce the risk of atherosclerosis."
Atherosclerosis, which is a leading
cause of death from heart attack and stroke, occurs when there is a
build-up of cholesterol-rich fatty areas called plaques in the arteries.
The break-up and dispersal of these plaques can block the blood flow
throughout the body, which can be fatal. It is estimated that
atherosclerosis accounts for more than 75 percent of all deaths from
cardiovascular disease.
The REVERSAL results reinforce the
outstanding effectiveness of Lipitor in treating patients who have high
cholesterol and signs of heart disease, said Dr. Joseph Feczko,
Pfizers executive vice president of Global Research and Development and
president of Worldwide Development. These results provide important new
information that will help physicians in treating the millions of
patients who suffer from this devastating disease.
The average LDL-C or bad cholesterol
levels of patients at the beginning of the study was 150 mg/dlwhile
accepted guidelines call for levels of <100 mg/dl. Prior to enrollment,
study participants were not taking medication to treat their high
cholesterol. Additionally, patients in the study had other heart disease
risk factors which may have included a history of diabetes, hypertension
or a previous heart attack. Ninety-seven percent of patients taking
Lipitor reached their recommended LDL cholesterol goal levels compared
to 67 percent of Pravachol patients. The rates of elevated liver enzymes
were low and similar in patients taking Lipitor 80 mg and Pravachol 40
mg. There were no reported cases of rare muscle problems associated with
muscle breakdown.
Researchers used technology known as
intravascular ultrasound, which is a three-dimensional method of
imaging, to measure the total plaque volume in a cross-section of the
artery wall over the length of the vessel. The total plaque volume of
the patients was measured at the beginning and at the conclusion of the
study.
Since the introduction of Lipitor seven
years ago, its safety and effectiveness have been supported through an
extensive clinical trial program, the Atorvastatin Landmark Program,
with more than 400 ongoing and completed trials involving more than
80,000 patients. Lipitor is the leading cholesterol-lowering therapy in
the world with more than 62 million patient years of experience.
Lipitor (atorvastatin calcium) is a
prescription drug used with diet to lower cholesterol. Lipitor is not
for everyone, including those with liver disease or possible liver
problems, women who are nursing, pregnant, or may become pregnant.
Lipitor is not indicated for the prevention of heart disease or heart
attacks.
Patients who take Lipitor should tell
their doctor about any unusual muscle pain or weakness. This could be a
sign of serious side effects. Patients should also inform their doctor
about any medications they are currently taking to avoid possible
serious drug interactions. Prescribing physicians may do simple blood
tests to monitor liver function before and during drug treatment. The
most commonly reported side effects are gas, constipation, stomach pain
and indigestion. They are usually mild and tend to go away.
For full prescribing information, please
call Pfizer Medical Information at 1-800-438-1985.
More Information:
www.lipitor.com
Lipitor ฎ Full U.S. Prescribing
Information (PDF)
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