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KIRKLAND, QC, Dec. 6 /CNW/ - Pfizer Canada Inc. announced today that Health Canada has approved the cholesterol-lowering therapy Lipitor(R) (atorvastatin calcium) for the reduction of the risk of heart attack and stroke for adults with type 2 diabetes mellitus and hypertension without clinically evident coronary heart disease but with other risk factors.
The approval is based on the findings of the Collaborative Atorvastatin Diabetes Study (CARDS). CARDS involved more than 2,800 patients with type 2 diabetes, no history of heart disease, and relatively-low levels of cholesterol. The study showed that patients who took Lipitor had a 37 per cent reduction in major cardiovascular events, which included heart attacks and stroke. In fact, 48 per cent fewer Lipitor treated patients experienced strokes compared to those who received placebo.
The findings of CARDS support the benefits of cholesterol control as an important diabetes management strategy. For people with diabetes, aggressive treatment of blood glucose, as well as the intensive management of cholesterol and blood pressure levels can prevent or significantly delay some of the medical complications associated with diabetes.
The CARDS study was stopped nearly two years earlier than planned because of the significant benefits for patients who took Lipitor compared with those who received placebo.
"We know that people with diabetes are about twice as likely to have a heart attack or stroke compared to people without diabetes and that cholesterol levels contribute to this increased risk," explained Dr. Lawrence Leiter, Head of Endocrinology at St. Michael's Hospital in Toronto. "CARDS was the first study done exclusively in patients with diabetes that has demonstrated the potential benefits associated with cholesterol reduction."
HIGH CHOLESTEROL AND DIABETES
According to The Canadian Diabetes Association's 2003 Clinical Practice Guidelines for the Prevention and Management of Diabetes: "Approximately 80 per cent of people with diabetes mellitus will die as a result of a vascular event. Thus, in attempting to reduce this excessive risk, all coronary risk factors in the person with diabetes must be addressed and treated aggressively."
The guidelines acknowledge reduction of cardiovascular risk, of which high cholesterol is a significant contributor, as the first priority in the prevention of diabetes complications.
CARDS
CARDS, which was initiated in the United Kingdom and Ireland, is a collaboration between Pfizer, University College London, Diabetes UK, the largest Diabetes charity in the UK, and the UK Department of Health.
After ASCOT-LLA, the CARDS study was the second landmark Lipitor study to end early due to a significant cardiovascular benefit seen in patients.
LIPITOR
Lipitor is a prescription drug indicated to lower 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 for coronary heart disease.
In addition, Lipitor is now 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 the leading cholesterol-lowering therapy in the world with more than 100 million patient years of experience. Since the introduction of Lipitor nine years ago, its safety and effectiveness have been supported through the Atorvastatin Landmark Program(TM), an extensive clinical program with more than 400 ongoing and completed trials involving more than 80,000 patients.
ABOUT PFIZER CANADA INC.
Pfizer Canada is the Canadian operation of Pfizer Inc., the world's leading research-based pharmaceutical company. Pfizer discovers and develops innovative prescription medicines for both humans and animals. As a proud member of IMAGINE, Canada's national program to promote corporate giving, volunteering and community support, Pfizer Canada provides financial support to over 1,000 not-for-profit organizations across the country. Pfizer Canada employs over 2,000 people and is headquartered in Kirkland, Quebec.
For further information: Dana Allison, Edelman, Tel.: (416) 979-1120 ext. 318; Silvie Letendre, Senior Manager Corporate Affairs, Pfizer Canada Inc., Tel.: (514) 693-4183 |
