Lipitor Provides Unprecedented Cardiovascular Risk Reductions In Diabetes Patients With Metabolic Syndrome And In Stroke PatientsLIPITOR PROVIDES UNPRECEDENTED CARDIOVASCULAR RISK REDUCTIONS IN DIABETES PATIENTS WITH METABOLIC SYNDROME AND IN STROKE PATIENTS
| New Orleans - March 28, 2007 |
Pfizer announced today that Lipitor® (atorvastatin calcium) Tablets 10 mg provided a significant 61 per cent reduction in stroke in patients with type 2 diabetes and metabolic syndrome but without heart disease. In a separate study, patients who had suffered a recurrent stroke or transient ischemic attack (TIA) during the trial had a significant 53 per cent reduction in the risk of major coronary events (death from cardiac causes, heart attack, or resuscitation after cardiac arrest) with Lipitor 80 mg. These analyses from two landmark clinical outcomes studies, Collaborative Atorvastatin Diabetes Study (CARDS) and Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL), were presented at the annual meeting of the American College of Cardiology. "What's impressive is the magnitude of cardiovascular efficacy, including a 61 per cent reduction in the risk of stroke, that Lipitor offered these patients who were at high risk for cardiovascular events," said Professor John Betteridge, a lead author of CARDS and professor of endocrinology and metabolism at University College London Hospital. "These results add to the unique and robust body of evidence for Lipitor that includes proven reductions in heart attacks and strokes, impressive average LDL lowering of 39 per cent to 60 per cent, and an established safety profile across a broad range of patients," said Dr. Michael Berelowitz, senior vice president of Pfizer's global medical division. New Analysis of the Collaborative Atorvastatin Diabetes Study (CARDS)
In a new analysis of more than 2,200 patients with type 2 diabetes who met the criteria for metabolic syndrome in CARDS: - Lipitor 10 mg provided a significant 41 per cent reduction in the risk of major cardiovascular events (death from coronary heart disease, heart attacks, strokes, certain types of heart surgery, chest pain) compared with placebo.
- Lipitor 10 mg provided a significant 61 per cent
reduction in the risk of stroke compared with placebo.
About the Overall CARDS Study
The CARDS study, published in The Lancet in 2004, involved more than 2,800 patients with type 2 diabetes with no history of heart disease, and relatively-low levels of cholesterol. The study showed that patients who took Lipitor 10 mg 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. In CARDS, Lipitor was well-tolerated. The overall frequency of adverse events or serious adverse events did not differ between Lipitor and placebo. About Metabolic Syndrome
Metabolic syndrome was defined in this analysis using the International Diabetes Federation criteria of central obesity and two or more of the following conditions: diabetes, treated hypertension or high blood pressure, high triglyceride and low levels of good cholesterol (HDL). Metabolic syndrome is a condition that affects thousands of Canadians, putting them at risk of heart disease and stroke, especially those aged 50 and over.i According to the International Diabetes Foundation, a quarter of the world's adults have metabolic syndrome and people with metabolic syndrome are twice as likely to die from, and three times as likely to have a heart attack or stroke compared with people without the syndrome. New Analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study
A new SPARCL analysis was conducted to evaluate if treatment with Lipitor 80 mg was associated with significant protection from coronary events after a recurrent stroke or TIA. In more than 850 patients who suffered a recurrent stroke or TIA during the trial: - Lipitor 80 mg reduced patients' risk of experiencing
major coronary events (death from cardiac causes, heart attack, or
resuscitation after cardiac arrest) by 53 per cent compared with placebo.
The benefits of Lipitor 80 mg in patients with a recurrent stroke or TIA seen in this analysis are consistent with the primary SPARCL results which demonstrated the benefit of Lipitor 80 mg in reducing stroke and coronary events among all patients in the study (n=4,731). About the Overall SPARCL Study
The SPARCL study, published in the New England Journal of Medicine in 2006, is the first major study designed to examine the benefits of lipid lowering therapy in stroke patients (n=4,731). Patients taking Lipitor 80 mg who had a prior stroke or TIA reduced their chances of having an additional stroke by 16 per cent, and major coronary events, such as heart attack, by 35 per cent, compared to placebo. In a post-hoc analysis of the SPARCL trial, there was a higher incidence of hemorrhagic stroke in patients taking Lipitor 80 mg compared with patients taking placebo. Despite the current hypothesis that low cholesterol levels may be tied to stroke, no significant increases in the incidence of hemorrhagic stroke have been seen in lower LDL-C levels in other trials involving Lipitor 80 mg. An analysis of three large clinical trials involving more than 10,000 patients with coronary heart disease (but who may not have had a previous stroke) treated with Lipitor 80 mg, revealed that the rate of hemorrhagic stroke was low (0.3%).ii Patients with prior hemorrhagic stroke at study entry appeared to be at an increased risk of hemorrhagic stroke. In SPARCL, Lipitor was well-tolerated. The rate of side effects such as elevated liver enzymes, muscle weakness or rhabdomyolysis were low and consistent with the known safety profile. About Stroke
Every year, an estimated 15 million people worldwide suffer strokes. Stroke, the fourth leading cause of death in Canada, kills as many as 16,000 Canadians each year. Annually, 40,000 to 50,000 Canadians have a stroke, and approximately 300,000 Canadians are living with the effects of stroke, including paralysis and impaired cognitive functioning. Often, those who have had a stroke are at increased risk for stroke recurrence. About Lipitor
Lipitor is a prescription drug 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 the leading cholesterol-lowering therapy in the world with more than 121 million patient years of experience. Since the introduction of Lipitor ten years ago, its safety and effectiveness have been supported through the Atorvastatin Landmark ProgramTM, an extensive clinical program with more than 400 ongoing and completed clinical trials involving more than 80,000 patients around the world. Lipitor has demonstrated cardiovascular outcomes benefits in a broad range of patients including the entire risk continuum. 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. - 30 - - Heart and Stroke Foundation. http://ww2.heartandstroke.ca/Page.asp?PageID=33&ArticleID=3533&Src=news&From=SubCategory. Last accessed March 26, 2007.
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