Health Canada Approves Lipitor for the Reduction of the Risk of Heart Attack in Patients with 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 heart attack. "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 events(1).
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 myocardial infarction(5).
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 smoking. 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,
(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: 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, email@example.com/
Posted: April 2007