Patients taking Lipitor (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 per cent 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 US 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 per cent of all strokes in the US, 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 per cent 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 haemorrhagic was very small. Patients taking Lipitor experienced a 22 per cent reduction in the risk of ischemic stroke. There were more patients in the Lipitor group who experienced hemorrhagic stroke (2.3 per cent) compared to patients taking placebo (1.4 per cent). There was no difference in the number of deaths from hemorrhagic stroke between the two treatment groups. A review of the Lipitor clinical programme, 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 per cent).

"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 enrolment 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.