- Stroke Patients With Mildly Elevated Cholesterol Levels Who Took Lipitor
Reduced Their Risk of Additional Strokes by 16 Percent
- Lipitor Patients Also Had a 35 Percent Reduction in Risk of Major
Coronary Events Such as Heart Attack
- Investigator: 'This is Important Information for Physicians Because
Patients Who Have Had a Stroke Are At Much Greater Risk for Suffering
Another One, Yet Treatment Options to Reduce Their Risk Are Limited.'
NEW YORK, Aug. 9 /PRNewswire-FirstCall/ -- Patients taking Lipitor(R)
(atorvastatin calcium) Tablets (80 mg) who had a prior stroke reduced their
chances of having an additional stroke and major coronary event such as
heart attack, according to results from the first major study designed to
examine the benefits of lipid lowering in stroke patients. The landmark
Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL)
trial was published today in The New England Journal of Medicine.
Up to one in five Americans who survive a first stroke will have
another stroke within five years, according to data from the National
Stroke Association. Patients entered the SPARCL trial with a history of
stroke or transient ischemic attack (TIA or mini-stroke) within the
previous six months, only mildly elevated cholesterol levels and no history
of heart disease. In the trial, Lipitor was shown to reduce the risk of an
additional stroke by 16 percent and major coronary events such as heart
attack, cardiac death or resuscitated cardiac arrest, by 35 percent
compared to placebo.
"This is important information for physicians because patients who have
had a stroke are at much greater risk for suffering another one, yet
treatment options to reduce their risk are limited," said Dr. Michael
Welch, SPARCL investigator, neurologist and president of Rosalind Franklin
University of Medicine & Science. "Patients taking Lipitor in this trial
showed a significant reduction in stroke and coronary events. This is
impressive when you consider that a majority of patients in the trial were
already being treated with medications such as blood thinning and blood
pressure lowering medications that are often given to reduce stroke risk."
Every year, an estimated 15 million people worldwide suffer strokes. In
the U.S. alone, there are nearly five million stroke survivors, touching
four out of five American families. Stroke survivors often must cope with
long rehabilitation to learn to manage paralysis, difficulties
understanding or forming speech or problems with awareness and thinking.
The lifetime cost of treating one patient with a stroke can amount to more
than $3 million.
"Stroke is a fatal or debilitating condition that has significant
impact on patients and their families, and reducing that risk is a key
priority in cardiovascular medicine," said Dr. John LaRosa, president and
professor of medicine, SUNY Downstate Medical Center. "These results
underscore the potential benefit of intensive Lipitor therapy for stroke
patients who may be at high risk for an additional stroke even in the
absence of previous heart disease."
Strokes are generally categorized into two types, ischemic and
hemorrhagic. Ischemic stroke (when the blood supply to a part of the brain
is suddenly blocked) is the more common type, accounting for 88 percent of
all strokes in the U.S., according to the American Heart Association.
Hemorrhagic strokes (which occur when a blood vessel in the brain leaks or
bursts) are less common and account for approximately 12 percent of all
strokes.
An analysis of the SPARCL data was designed and conducted after the
study ended to explore the types of strokes, ischemic or hemorrhagic, that
occurred among patients in the study. The vast majority of strokes in this
trial were ischemic while the number who experienced hemorrhagic was very
small. Patients taking Lipitor experienced a 22 percent reduction in the
risk of ischemic stroke. There were more patients in the Lipitor group who
experienced hemorrhagic stroke (2.3 percent) compared to patients taking
placebo (1.4 percent). There was no difference in the number of deaths from
hemorrhagic stroke between the two treatment groups. A review of the
Lipitor clinical program, involving more than 10,000 patients with coronary
heart disease taking Lipitor 80 mg, shows the incidence of hemorrhagic
stroke was very low (0.3 percent).
"Previous clinical trials have demonstrated that Lipitor can reduce the
chances of a first stroke," said Dr. Joseph Feczko, Pfizer's chief medical
officer. "The new SPARCL data provide physicians and patients with one more
reason to consider the benefits of Lipitor. SPARCL is another example of
the groundbreaking research being supported by Pfizer to identify potential
improvements in patient care."
SPARCL is an investigator-led trial that is being coordinated by an
independent steering committee and funded by Pfizer.
In SPARCL, 4,731 patients who had no history of heart disease and had
experienced a stroke or TIA within six months prior to trial enrollment
were followed for an average of about five years. Patients had mildly
elevated cholesterol levels, and were treated with either Lipitor (80 mg)
or placebo. Before the trial results were known, the investigators leading
the trial decided to analyze the results taking into account baseline
characteristics, such as age and gender. Epidemiologic data has shown, for
example, that the risk of stroke significantly increases with age.
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.
Important Information
Lipitor is the most prescribed cholesterol-lowering therapy in the
world, with nearly 121 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 medication. It is used in patients with
multiple risk factors for heart disease such as family history, high blood
pressure, age, elevated LDL ("bad" cholesterol), low HDL ("good"
cholesterol) or smoking to reduce the risk of heart attack and stroke. When
diet and exercise alone are not enough, Lipitor is used along with a
low-fat diet and exercise to lower cholesterol.
Lipitor is also used in patients with type 2 diabetes and at least one
other risk factor for heart disease such as high blood pressure, smoking or
complications of diabetes, including eye disease and protein in urine, to
reduce the risk of heart attack and stroke.
Lipitor is not for everyone. It is not for those with liver problems.
And it is not for women who are nursing, pregnant or may become pregnant.
Patients taking Lipitor should tell their doctors if they feel any new
muscle pain or weakness. This could be a sign of rare but serious muscle
side effects. Patients should tell their doctors about all medications they
take. This may help avoid serious drug interactions. Doctors should do
blood tests to check liver function before and during treatment and may
adjust the dose. The most common side effects are gas, constipation,
stomach pain and heartburn. They tend to be mild and often go away.
For additional product information, visit http://www.Lipitor.com.
SOURCE Pfizer Inc
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