KIRKLAND, QC, April 25 /CNW/ - Pfizer Canada Inc. announced today that
Health Canada has approved the cholesterol-lowering therapy Lipitor(R)
(atorvastatin calcium) to reduce the risk of myocardial infarction in patients
with clinically evident coronary heart disease.
The approval is based on the wealth of evidence available to date and
further reinforces the previous indication for reduction of cardiovascular
events, such as myocardial infarction and stroke, in patients without
clinically evident coronary heart disease (CHD), but with risk factors for
CHD. This new approval expands the use of Lipitor to patients at risk for
cardiovascular events because of established heart disease such as a prior
"Lipitor is the world's most extensively studied cholesterol-lowering
medication, and is supported by a large clinical trial program that includes
more than 10 cardiovascular outcomes trials with more than 50,000 patients
across a broad spectrum of risk," said Dr. Bernard Prigent, Vice President and
Medical Director, Pfizer Canada Inc. "Lipitor is the only statin that offers a
unique combination of proven significant cardiovascular event reductions,
impressive average LDL lowering of 39 per cent to 60 per cent, and a
well-established safety profile."
For example, in a recent five-year trial involving 10,000 patients with
both heart disease and elevated LDL levels, patients taking Lipitor 80 mg had
a significant 22 per cent 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 22 per cent reduction in the risk of
heart attack. 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
Lipitor is the most prescribed cholesterol-lowering therapy in the world,
with nearly 139 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 build-up of plaque including cholesterol and other
substances in the walls of arteries. This build-up can cause arteries to
become thick and hard (known as arteriosclerosis). It can also clog arteries,
causing them to carry a reduced blood (nutrients 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.
Cardiovascular disease is the leading cause of death in Canada(2).
Worldwide, there are an estimated 32 million heart attacks and strokes each
year(3). In 2002, cardiovascular disease accounted for more than 74,000 deaths
in Canada(4). In 2005 more than 124,000 Canadians were hospitalized due to
In addition to the new indication mentioned above, Lipitor is indicated
to lower LDL cholesterol and other fats in the blood (such as triglycerides)
when response to diet and other lifestyle measures alone have been inadequate,
in both adults and pediatric patients (boys and postmenarchal girls, 10 to 17
years of age, with heterozygous familial hypercholesterolemia). Lipitor is
also indicated to reduce the risk of myocardial infarction in adult
hypertensive patients without clinically evident coronary heart disease, but
with at least three additional risk factors (such as 55 years and older,
smoking and type 2 diabetes) for coronary heart disease.
In addition, Lipitor is also indicated to reduce the risk of myocardial
infarction and stroke in adult patients with type 2 diabetes mellitus and
hypertension without clinically evident coronary heart disease, but with other
risk factors such as age (55 years and older) retinopathy, albuminuria or
Lipitor is generally well-tolerated. Adverse reactions have usually been
mild and transient. The most common adverse events were gastrointestinal
complaints, headache, pain, muscle pain and fatigue.
About Pfizer Canada Inc.
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc, the world's
leading pharmaceutical company. Pfizer discovers, develops, manufactures and
markets prescription medicines for humans and animals. Pfizer's ongoing
research and development activities focus on a wide range of therapeutic areas
following our guiding aspiration...Working for a healthier world. For more
information, visit www.pfizer.ca.
(1) LaRosa JC, Grundy SM, Waters DD, et al; Treating to New Tragets (TNT)
Investigators. Intensive lipid lowering with atorvastatin in
patients with stable coronary disease. N Engl J Med 2005;352:1425-35.
(2) Heart and Stroke Foundation of Canada.
Last accessed February 8, 2007.
(3) World Health Organization,
Last accessed April 19, 2007
(4) Heart and Stroke Foundation of Canada.
Last accessed February 8, 2007.
(5) GRACE 2006
For further information:
For further information: or to arrange an interview with a physician:
Laura Espinoza, Edelman, (416) 979-1120, ext. 245, firstname.lastname@example.org;
Christian Marcoux, Pfizer Canada Inc., (514) 206-8192,