October 8, 2007

NEJM study shows cholesterol-lowering drug effective therapy for reducing incidence of 2nd strokes

Dr. Chaturvedi, WSU professor of neurology, among investigators publishing findings in New England Journal of Medicine

Treating first-time stroke patients with aggressive cholesterol-lowering therapy substantially reduces risk of subsequent stroke occurrence in these patients, a new study has found. WSU School of Medicine researchers are among a group of international investigators whose discovery paves the way for a new treatment option for stroke prevention after an initial stroke has occurred, when current medical interventions are limited.

The research is published in the Aug. 10 edition of the New England Journal of Medicine.

Dr. Seemant Chaturvedi, WSU professor of neurology and director of the WSU/DMC stroke program, is a co-investigator and co-author of the study. "The results show the benefits of statin—or cholesterol lowering-- therapy in patients with a recent stroke, and will have a significant impact on the way stroke patients are treated in the community," noted Dr. Chaturvedi. "Significantly, this study also adds to our ability to help prevent a second stroke in our patients."

The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study is the first large placebo-controlled prospective trial to investigate patients with prior stroke or transient ischemic attack (TIA), or "mini-stroke," who do not have established coronary heart disease. The study enrolled 4,731 patients without history of heart disease and who had experienced a stroke or TIA within six months prior to trial enrollment. Patients who had mildly elevated cholesterol levels were treated with either the cholesterol-lowering drug, Lipitor, or given placebo. The patients were followed for an average of five years.

In the studied patient population, Lipitor reduced the risk for stroke by 16 percent and the risk of major coronary events by 35 percent. Eighty-five percent of the strokes in the study were ischemic, the most common type of stroke, which occurs when the blood supply to a part of the brain is suddenly blocked.

A separate analysis of the SPARCL data that was designed and conducted after the study ended showed that patients taking Lipitor experienced a 22 percent reduction in the risk of ischemic stroke. This secondary analysis also found that patients in the Lipitor group experienced a 2.4 percent increase in the number of hemorrhagic strokes, which occur when a blood vessel in the brain leaks, compared to patients taking placebo, at 1.4 percent. However, the number of patients in SPARCL experiencing this type of stroke was too few to be significant.

The SPARCL study results are adjusted for factors including age and gender. The dosage of 80 mg of Lipitor was well tolerated, with incidents of adverse events low. The majority, or 94 percent, of patients in the trial were already treated with aspirin or other anti-platelet therapies and 69 percent of the patients received blood pressure-lowering therapies.

The SPARCL study was funded by Pfizer Inc., which manufactures Lipitor. The study included 200 sites in the United States, Europe and Australia and was investigator-led and coordinated by an independent steering committee.

Dr. Chaturvedi is an internationally respected clinician and researcher in stroke treatment and prevention. His work has been funded steadily through National Institutes of Health and other sources. He has been named one of the Best Doctors in America and one of the Best Doctors in Detroit by the Detroit Free Press and he is an elected member of the American Neurological Association.

 

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