* Torcetrapib/Atorvastatin Clinical Trial Program is the Largest Ever
Conducted by Pfizer: 25,000 Patients Enrolled in Studies Underway Around
the World
* Pfizer Clinician: "First Data to Show that there are Important
Differences in Raising HDL Cholesterol Levels with Torcetrapib and
Atorvastatin Depending on Whether it is Dosed in the Morning or Evening"
* TNT Trial Investigator: "The TNT Sub-Analysis Suggests that HDL
Cholesterol May Also Provide Important Therapeutic Benefits that May
Result in Further Reductions in Cardiovascular Risk"
ATLANTA, March 14 /PRNewswire-FirstCall/ -- Pfizer said today that new
data, involving its medicine in development torcetrapib/atorvastatin, provides
important information on the benefit of raising HDL, or "good" cholesterol,
while simultaneously lowering LDL, or "bad" cholesterol. These new findings
may play a critical role in reducing the burden of cardiovascular disease and
potentially improving quality of life for patients. Data from three separate
studies were presented this week at the American College of Cardiology
meeting.
"As the first potential treatment to offer substantial HDL cholesterol
elevations and significant LDL cholesterol lowering, torcetrapib/atorvastatin
could well change how physicians manage their patients with cardiovascular
disease," said Dr. John LaMattina, president of Pfizer Global Research and
Development. "This comprehensive clinical trial program will help determine
if this hypothesis can offer patients the benefit of slowing atherosclerosis
and ultimately preventing cardiovascular events beyond what can be achieved
with Lipitor alone."
It is estimated that 71 million Americans suffer from cardiovascular
disease, a leading cause of death in the United States. Most people with
elevated cholesterol, a leading risk factor for heart attacks and strokes, are
either not diagnosed or have not reached their target LDL levels with
medication. In addition, research has shown that raising HDL-cholesterol may
provide further benefits in the management of cardiovascular disease, which
may have the potential to further reduce cardiovascular risk for patients.
Discovered and developed by Pfizer, torcetrapib works by blocking CETP
(cholesterol ester transfer protein) which is a protein that regulates
cholesterol and is responsible for transferring cholesterol from its "good"
HDL carrier to LDL, the "bad" carrier of cholesterol that results in plaque
buildup in the arteries. Scientists believe that CETP inhibition raises HDL
levels which results in cholesterol removal from the artery walls. Torcetrapib
also lowers LDL cholesterol and LDL is known to cause heart attacks and
stroke.
Presentation 1 - HDL and LDL as Predictors for CV Disease/Sub-
Analysis of Lipitor TNT Study
The primary objective of the Treating to New Targets (TNT) study was to
demonstrate the clinical benefits of intensive LDL cholesterol lowering. This
sub-analysis of TNT found that patients treated to LDL cholesterol levels that
were below current medical guidelines showed a direct relationship between HDL
cholesterol levels and the frequency of cardiovascular events -- 1 mg/dL
increase in HDL cholesterol levels was estimated to have an associated 2
percent reduction in the risk of a heart attack or stroke.
"This study further supports the potential benefits of managing HDL levels
as an additional target for patients who are already receiving statin
therapy," said Dr. Philip Barter, lead author, TNT sub-analysis, The Heart
Institute in Sydney, Australia. "While lowering LDL cholesterol remains a
critical focus in cardiovascular disease prevention, the TNT sub-analysis
suggests that HDL cholesterol may also provide important therapeutic benefits
that may result in further reductions in cardiovascular risk."
Presentation 2 - Torcetrapib/Atorvastatin: AM vs PM: Examining the Optimal
Time of Dosing
Patients received either torcetrapib (100 mg) alone or torcetrapib (60 mg)
and atorvastatin (20 mg) together, taken in the mornings or evenings, to
determine if greater increases in HDL would be achieved based on the time of
dosing. Torcetrapib, a CETP inhibitor is believed to be most effective when
taken in the morning. Unlike most statins -- which are taken in the evening
for maximum reduction in LDL cholesterol -- atorvastatin can be dosed anytime
of the day and obtain equal LDL lowering effects.
Patients who took torcetrapib (60 mg) and atorvastatin (20 mg) in the
morning experienced the most significant increase of 54.4 percent in HDL-
cholesterol which was 12 percent higher than patients who took both
torcetrapib and atorvastatin in the evening. Additionally, patients achieved
a reduction in LDL cholesterol levels regardless of the time of day that
therapy was taken.
"This is the first data to show that there are important differences in
raising HDL cholesterol levels with torcetrapib depending on whether it is
dosed in the morning or evening, and also highlights the flexibility and
efficacy of atorvastatin," said Dr. Megan Gibbs, associate director of
clinical research of Pfizer Global Research and Development.
Presentation 3 - Torcetrapib/Atorvastatin: Exploring Benefits of Lipid-
Modifying Effects
Pfizer researchers also presented data from another study involving 493
patients to determine the effectiveness of torcetrapib (30, 60, 90 mg) either
alone or in combination with atorvastatin (10, 20, 40, 80 mg).
In particular, the study addressed the HDL and LDL particle size and
number using new technology -- nuclear magnetic resonance (NMR). Leading
researchers believe both larger HDL and LDL particles, and lower numbers of
LDL particles are less likely to contribute to the development of
atherosclerosis, or plaque build-up in the arteries, which is important in
cardiovascular health. In this study, patients taking torcetrapib and
atorvastatin together experienced a decrease in LDL cholesterol, and an
increase in HDL cholesterol levels, as well as increases in the particle size
of both HDL and LDL.
"These data provide important information on how CETP inhibition with
torcetrapib affects the number and nature of lipid particles," said Dr. Tom
Thuren, director of clinical development, Pfizer Global Research and
Development. "While the impact of these changes on cardiovascular risk is not
currently known, we are diligently examining this and other areas in a large-
scale clinical trial program."
In this study, side effects of torcetrapib and Lipitor were similar to
those most commonly associated with statin therapy. Patients taking 60 mg of
torcetrapib with Lipitor also experienced an increase in systolic blood
pressure of approximately 2 mm Hg, which will be further defined in ongoing
phase 3 studies.
Pfizer's torcetrapib/atorvastatin development program is the largest and
most comprehensive clinical trial program the company has ever undertaken and
is studying some 25,000 patients at hundreds of medical centers worldwide at a
cost of about $800 million.
Lipitor Information
Lipitor is the most prescribed cholesterol-lowering therapy in the world,
with nearly 107 million patient-years of experience.
It is used, in patients with multiple risk factors for heart disease such
as family history, high blood pressure, age, low HDL cholesterol or smoking,
to reduce the risk of heart attack or stroke and, along with a low-fat diet,
to lower cholesterol.
Lipitor is also used in patients with type 2 diabetes and one other risk
factor such as high blood pressure, smoking, or other complications of
diabetes, including eye disease and protein in urine, to reduce the risk of
stroke and heart attack.
Lipitor is not for everyone. It is not for those with liver problems. And
it is not for women who are nursing, pregnant, or may become pregnant.
Patients who take Lipitor should tell their doctor about any unusual
muscle pain or weakness. This could be a sign of serious muscle side effects.
Patients should tell their doctor about all the medicines they take. This may
help avoid serious drug interactions. Doctors should do blood tests to check
patients' liver function before and during drug treatment, and may adjust the
dose of Lipitor. Its most common side effects are gas, constipation, stomach
pain, and heartburn. They tend to be mild and often go away.
For more product information, visit http://www.Lipitor.com.
DISCLOSURE NOTICE: The information contained in this release is as of
March 14, 2006. Pfizer assumes no obligation to update any forward-looking
statements contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information about a product
candidate and its potential benefits that involves substantial risks and
uncertainties. Such risks and uncertainties include, among other things, the
uncertainties inherent in research and development; decisions by regulatory
authorities regarding whether and when to approve any drug applications that
may be filed for the product candidate as well as their decisions regarding
labeling and other matters that could affect its availability or commercial
potential; and competitive developments.
A further list and description of risks and uncertainties can be found in
Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31,
2005 and in its reports on Form 10-Q and Form 8-K.
SOURCE Pfizer Inc
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