ORLANDO, FL, Nov. 6 /CNW/ - Pfizer announced today that Lipitor(R)
(atorvastatin calcium) Tablets (80 mg) was more effective than simvastatin (20
mg-40 mg) in reducing the risk of multiple cardiovascular events in patients
with a history of heart attacks in the Incremental Decreases through
Aggressive Lipid Lowering (IDEAL) clinical trial.
Cardiovascular events included heart attack, stroke, and cardiac
revascularization procedures such as bypass surgery and angioplasty. The
results were presented at the Annual Scientific Sessions of the American Heart
All 8,888 patients enrolled in the trial had a prior heart attack, and
2,546 of them experienced at least one additional cardiovascular event after
entering the trial. A new post-hoc analysis (planned after study closed)
reported that 1,048 patients had a second cardiovascular event during the
course of the trial. In those patients treated with Lipitor, there was a
significant 24 per cent reduction in relative risk of having that second event
compared to those treated with simvastatin (p less than 0.0001). The analysis
also found that 416 patients had a third event during the course of the trial.
In those patients treated with Lipitor there was a significant 19 per cent
reduction in relative risk of having that third event compared to simvastatin
(p = 0.035). The overall results of this analysis are even more robust in
patients who were more adherent to treatment.
In the original analysis of IDEAL, the primary endpoint of first major
coronary event (nonfatal heart attack, coronary heart disease death, cardiac
arrest) during the trial was reduced in the Lipitor patients compared to
simvastatin patients by 11 per cent (p = 0.07), which did not reach
statistical significance. There was a significant 17 per cent (p = 0.02)
reduction in risk for first nonfatal heart attack and significant 13 per cent
(p = 0.02) reduction in risk of first major cardiovascular events major
coronary events and stroke) in patients taking Lipitor.
"Heart attack patients are extremely vulnerable to experiencing even more
cardiovascular events. After such an event, the most important task of the
treating physician is to reduce the risk of the next cardiovascular event,"
said Dr. Matti J. Tikkanen, professor of medicine at Helsinki University, and
lead author of the analysis. "This analysis showed that Lipitor was more
effective than simvastatin in reducing the risk of recurrent cardiovascular
events. Our results provide evidence that patients who have already
experienced cardiovascular events benefit from Lipitor 80 mg."
The analysis is unique because it evaluated all cardiovascular events
that occurred during the five year course of the trial, whereas analyses of
most statin trials are usually limited to evaluating the occurrence of the
first event only.
"This unique analysis confirmed the benefit of long-term Lipitor 80 mg
therapy in patients who have had multiple cardiovascular events," said Dr.
Rochelle Chaiken, vice president of Pfizer's Cardiovascular and Metabolic
Medical Division. "When treating patients with cardiovascular disease risk it
is important to take into account the clinical data for the medication so that
the right medicine is chosen for the individual patient."
About Heart Disease and Stroke
Cardiovascular disease is the leading cause of death in Canada.(1) It is
estimated that there are more than 70,000 heart attacks in Canada each year.
In 2003, more than 18,500 (18,662) Canadians died from heart attacks.(2)
Stroke is the fourth leading cause of death in Canada and accounts for seven
per cent of all deaths each year.(3) Approximately 300,000 Canadians are
living with the effects of stroke, including paralysis and impaired cognitive
functioning.(4) Often, those who have had a stroke are at increased risk for
Cardiovascular diseases have a significant economic impact. Health Canada
estimates that the total cost of cardiovascular diseases to the Canadian
economy in 1998 was $18,472.9 million, which includes a direct cost of
$6,818.1 million and an indirect cost of $11,654.8 million.(5)
Lipitor is the most extensively studied and most prescribed
cholesterol-lowering therapy in the world, with nearly 144 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.
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.
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.
In addition, Lipitor is indicated to reduce the risk of myocardial
infarction in patients with clinically evident coronary heart disease.
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) Statistics Canada. Deaths, 2002. Available at http://statcan.ca
(2) Statistics Canada, Causes of Death 2003. Mortality, Summary List of
(3) Heart and Stroke Foundation. Understanding Transient Ischemic Attack
(TIA). June 2006.
(5) Heart and Stroke Foundation. Growing Burden of Heart Disease and
For further information:
For further information: Laura Espinoza, Edelman, (416) 979-1120, ext.
245, firstname.lastname@example.org; Christian Marcoux, Pfizer Canada Inc., (514)