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.
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