Caduet Reduces 10-Year Calculated Risk of Coronary Heart Disease, Fatal Cardiovascular Disease

By Pfizer Inc., PRNE
Sunday, June 20, 2010

OSLO, Norway, June 21, 2010 - Caduet(R) (amlodipine besylate/atorvastatin calcium) was associated with
a significantly reduced calculated 10-year risk of coronary heart disease
(CHD) based on a Framingham risk assessment model. In addition, Caduet was
shown to reduce calculated fatal cardiovascular disease (CVD) risk, as a
secondary trial endpoint based on the SCORE risk assessment model. The
Framingham and SCORE risk assessment models are widely used in the U.S. and
EU, respectively. These data from the CRUCIAL (Cluster Randomized Usual Care
vs. Caduet Investigation Assessing Long-term Risk) trial were presented
yesterday at the 20th Scientific Meeting of the European Society of
Hypertension (ESH) in Oslo, Norway.

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"The data presented at ESH are important because they show the potential
benefit of Caduet, which combines blood pressure and cholesterol-lowering
medications in a single pill, over usual care in a real-life clinical
setting," said Professor Jose Zamorano of the Hospital Clinico San Carlos,
Madrid, Spain, and chair of the CRUCIAL steering committee. "The findings
suggest that Caduet may have the potential to significantly reduce CV risk in
patients with two of the most common modifiable risk factors that contribute
to cardiovascular disease: high cholesterol and high blood pressure."

The CRUCIAL trial randomized 136 physicians to either Caduet or usual
care. The physicians then treated a total of 1,461 men and women aged 35-79
who had hypertension, three or more cardiovascular risk factors, no CHD, and
total cholesterol less than or equal to 6.5 mmol/l (250 mg/dl) with their
assigned therapy. Usual care included physicians' choice of any locally
approved medications for lowering blood pressure or cholesterol, including
but not limited to amlodipine and atorvastatin, prescribed according to local
clinical practice. Physicians in the Caduet arm treated eligible patients
with Caduet and, if needed, other blood pressure-lowering drugs.

Caduet reduced patients' calculated 10-year risk of total CHD,
demonstrating a relative risk reduction of 27 percent after 12 months of
treatment compared with usual care. Risk was assessed using a Framingham
model, which calculates heart disease risk based on a combination of health
and lifestyle factors, including sex, age, blood pressure, total or
LDL-cholesterol, HDL cholesterol, smoking and diabetes status.

A secondary trial endpoint of calculated fatal CVD risk reduction showed
a 23 percent relative difference between the two treatment arms, with a
greater reduction in the Caduet arm, as measured with SCORE (Systematic
Coronary Risk Evaluation), a European model. The risk factors included in the
SCORE calculation are sex, age, smoking, systolic blood pressure, and total

In this trial, Caduet was generally well-tolerated. The adverse event
profile in the Caduet arm was consistent with previous safety experience for
this medication.

About CHD

An estimated 16.7 million deaths annually worldwide - or 29.2 percent of
total deaths - result from various forms of CVD, which are often caused in
part by high blood pressure and high cholesterol. These two risk factors
frequently occur together; an estimated 55 percent of people with high blood
pressure also have high cholesterol, and 43 percent of those with high
cholesterol also have high blood pressure.

About the CRUCIAL Study

The CRUCIAL trial was designed to compare the impact on calculated
Framingham risk for coronary heart disease of a Caduet-based treatment
strategy of simultaneously lowering blood pressure and cholesterol with that
of usual care. CRUCIAL was a 12-month, international, multicenter,
prospective, cluster-randomized, parallel-design, open-label trial conducted
in 19 countries in Asia, the Middle East, Europe, and Latin America.

For this study, cluster-randomization was used to prevent potential
cross-over effects between treatment arms in this open-label study mimicking
real-world clinical practice. In general, in a cluster-randomized trial,
doctors, not patients, are randomized to the relevant treatments; physicians
then treat all their enrolled patients with their assigned therapy - in this
case, either Caduet or usual care. To ensure similar patient types in both
trial arms, doctors enrolled their eligible patients in the study before
knowing which treatment they would be assigned.

Important Prescribing Information

Caduet is a prescription drug that combines two medicines, Norvasc(R)
(amlodipine besylate) and Lipitor(R) (atorvastatin calcium). Norvasc is used
to treat high blood pressure (hypertension), chest pain (angina), or blocked
arteries of the heart (coronary artery disease); Lipitor is used along with a
low-fat diet to lower the LDL ("bad") cholesterol and triglycerides in the
blood. It can raise the HDL ("good") cholesterol as well. Lipitor is used to
lower the risk of heart attack, stroke, certain types of heart surgery, and
chest pain in patients who have heart disease or risk factors for heart
disease such as age, smoking, high blood pressure, low HDL, or family history
of early heart disease.

Lipitor can also lower the risk of heart attack or stroke in patients
with diabetes and risk factors such as diabetic eye or kidney problems,
smoking, or high blood pressure.

Caduet 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.

If you take Caduet, tell your doctor if you feel any new muscle pain or
weakness. This could be a sign of rare but serious muscle side effects. Tell
your doctor about all of the medicines you take. This may help avoid serious
drug interactions. Your doctor should do blood tests to check your liver
function before and during treatment and may adjust your dose. If you have
any heart problems, be sure to tell your doctor.

The most common side effects are edema, headache and dizziness.

Caduet is one of many options for treating high blood pressure and high
cholesterol, in addition to diet and exercise.

Andrew Thomas, +44-1737-330611, Mobile: +44-7814-528928, Andrew.D.Thomas at; or Investors, Suzanne Harnett, +1-212-733-8009, Suzanne.Harnett at, both of Pfizer Inc.

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