Lipitor Receives FDA Approval for Five New Indications in Patients With Heart Disease
08 March 2007 - 2:18AM
PR Newswire (US)
The Only-Approved Cholesterol-Lowering Medication for Reducing the
Risk of Hospitalization for Heart Failure NEW YORK, March 7
/PRNewswire-FirstCall/ -- Pfizer announced today that the U.S. Food
and Drug Administration (FDA) has approved Lipitor(R) (atorvastatin
calcium) Tablets to reduce the risk of nonfatal heart attacks,
fatal and non-fatal strokes, certain types of heart surgery,
hospitalization for heart failure, and chest pain in patients with
heart disease. Lipitor is the first cholesterol-lowering medication
to receive FDA approval for the reduction of the risk of
hospitalization for heart failure. This new approval expands the
use of Lipitor to patients at high risk for cardiovascular events
because of established heart disease such as prior heart attack,
prior heart surgery, or chest pain with evidence of clogged
arteries. Previously, Lipitor was approved to reduce cardiovascular
events in patients without heart disease. "These new indications
are important since many patients who have heart disease remain at
risk for another cardiovascular event, and now these indications
broaden the means to reduce their risk," said Dr. John C. LaRosa,
president and professor of medicine at the State University of New
York Downstate Medical Center in Brooklyn, N.Y. and lead
investigator for the Treating to New Targets (TNT) trial. "The
significant reduction in cardiovascular events seen in the TNT
trial can now be applied to everyday practice and benefit people
with heart disease in the United States." The approval is based on
results from the landmark TNT trial and supported by findings from
the Incremental Decrease in Endpoints through Aggressive Lipid
Lowering (IDEAL) trial. The results of these two trials were
important enough to be referenced in updated treatment guidelines
issued jointly by the American Heart Association and the American
College of Cardiology in 2006. The five-year TNT study involved
10,000 patients with both heart disease and elevated LDL levels. It
is the longest and largest study of Lipitor 80 mg efficacy and
safety. In this study, patients taking Lipitor 80 mg had a
significant 22 percent reduction in the risk of major
cardiovascular events over and above patients taking Lipitor 10 mg.
In addition, patients treated with Lipitor 80 mg had a significant
26 percent reduction in the risk of hospitalization for heart
failure. There were more serious adverse events and
discontinuations due to adverse events with Lipitor 80 mg compared
with Lipitor 10 mg. However, there was no difference in the overall
frequency of treatment-related adverse events. "Lipitor is the
world's most extensively studied cholesterol-lowering medication,
and is supported by a large clinical trial program that includes
more than ten cardiovascular outcomes trials with over 50,000
patients across a broad spectrum of risk," said Dr. Michael
Berelowitz, Pfizer senior vice president of global medical.
"Lipitor is the only statin that offers a unique combination of
proven significant cardiovascular event reductions, impressive
average LDL lowering of 39 percent to 60 percent, and a
well-established safety profile." Lipitor is the most prescribed
cholesterol-lowering therapy in the world, with nearly 133 million
patient-years of experience. Lipitor is supported by an extensive
clinical trial program involving more than 400 ongoing and
completed trials with more than 80,000 patients. Atherosclerosis is
a buildup of plaque including cholesterol and other substances in
the walls of arteries. This buildup can cause arteries to become
thick and hard (known as arteriosclerosis). It can also clog
arteries, causing them to carry a reduced blood and oxygen supply
to the organs. In the heart, this is manifested as coronary heart
disease, a form of cardiovascular disease, and can result in a
heart attack. In the brain, atherosclerosis can result in a stroke.
More than 15 million Americans have a history of coronary heart
disease. This year, an estimated 300,000 Americans will have a
recurrent heart attack. The prevalence of coronary heart disease
also contributes to burdensome healthcare costs for patients as
well as the nation's healthcare system. The American Heart
Association expects direct and indirect costs of coronary heart
disease to total nearly $152 billion in 2007. Important US
Prescribing Information Lipitor is a prescription medication. It is
used in patients with multiple risk factors for heart disease such
as family history, high blood pressure, age, low HDL ("good"
cholesterol) or smoking to reduce the risk of heart attack, stroke,
certain kinds of heart surgery, and chest pain. Lipitor is used in
patients with existing coronary heart disease to reduce the risk of
heart attack, stroke, certain kinds of heart surgery,
hospitalization for heart failure, and chest pain. Lipitor is also
used in patients with type 2 diabetes and at least one other risk
factor for heart disease such as high blood pressure, smoking or
complications of diabetes, including eye disease and protein in
urine, to reduce the risk of heart attack and stroke. When diet and
exercise alone are not enough, Lipitor is used along with a low-fat
diet and exercise to lower cholesterol. 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 taking Lipitor should tell their doctors if they feel any
new muscle pain or weakness. This could be a sign of rare but
serious muscle side effects. Patients should tell their doctors
about all medications they take. This may help avoid serious drug
interactions. Doctors should do blood tests to check liver function
before and during treatment and may adjust the dose. The most
common side effects are gas, constipation, stomach pain and
heartburn. They tend to be mild and often go away. For additional
product information, visit http://www.lipitor.com/. DATASOURCE:
Pfizer Inc CONTACT: Vanessa Aristide, +1-212-733-3784, or Rebecca
Hamm, +1-212-733-8811, both of Pfizer Inc. Web site:
http://www.pfizer.com/ http://www.lipitor.com/ Company News
On-Call: Pfizer's press releases are available through PR
Newswire's Company News On-Call service on PRN's Web Site. Visit
http://www.prnewswire.com/comp/688250.html Company News On-Call:
http://www.prnewswire.com/comp/688250.html
Copyright