NEW ORLEANS, March 27 /CNW/ - Pfizer announced today that Lipitor(R)
(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
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.
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.
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
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 Program(TM), 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
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.
(i) Heart and Stroke Foundation.
Last accessed March 26, 2007.
(ii) (*)MIRACL, TNT, and IDEAL
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