August 11, 2006

Statin drug found to cut stroke risk

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Chief Nursing Officer Marilyn Dubree, M.S.N., R.N.
Photos by Dana Johnson

Statin drug found to cut stroke risk

New evidence suggests that a cholesterol-lowering drug that successfully prevents heart attacks also reduces the risk of stroke in patients without known heart disease.

The Stroke Prevention by Aggressive Reduction in Cholesterol Levels, or SPARCL, study is the first major, multi-center clinical trial to focus on the use of a cholesterol-lowering “statin” drug to reduce recurrent strokes as well as other outcomes in a group of stroke patients.

In the study, published this week in the New England Journal of Medicine, 80 mg of atorvastatin (Lipitor) was given to subjects who had recently suffered a stroke or transient ischemic attack (TIA), and had normal to mildly elevated cholesterol levels. The statin therapy reduced the risk for stroke by 16 percent and the risk of major coronary events by 35 percent.

This is important information for physicians and patients, because once a patient suffers a stroke, current treatment options are limited.

“Every 30 seconds someone in the U.S. has a heart attack and every 45 seconds someone has a stroke. Stroke is the leading cause of adult disability in America, and vascular disease is the leading cause of death in the world,” said Alfred Callahan, M.D., a clinical professor at the Vanderbilt University School of Nursing and a member of the study's independent steering committee. “SPARCL gives us scientific data that shows this high-dose statin can help stroke patients as well as heart attack patients.”

The eight-year SPARCL study started in 1998 and included 207 sites across the world, including VUMC. Howard Kirshner, M.D., vice chair of Neurology and director of the Vanderbilt Stroke Center, served as the local principal investigator for Vanderbilt, which recruited 30 subjects.

“SPARCL is a milestone study in the growing evidence for the use of cholesterol-lowering, HMG-CoA Reductase Inhibitors ("Statin drugs") in the management of vascular disease.

“Combined with the Heart Protection Study published in 2002, there is now a body of knowledge that shows that most people who have had a stroke should be on a statin drug unless they have an LDL below 100,” said Kirshner.

Callahan said the findings provide important evidence about the link between stroke and heart attack, which are often treated as very separate health concerns. From Callahan's perspective, SPARCL proves that the integrity and health of the blood vessels is perhaps even more important than the health of any individual organ.

“Whether a person has heart trouble or brain trouble, we have the ability to help the blood vessel wall,” said Callahan.

The only important negative finding in the study was that study subjects who took 80 mg of atorvastatin experienced an increase in the number of hemorrhagic strokes (2.4 percent), which occurs when a blood vessel in the brain leaks, compared to patients taking placebo (1.4 percent).

In addition to VUMC, Saint Thomas Hospital and Centennial Hospital, in Nashville, and Chattanooga Neurology Associates in Chattanooga, Tenn., were also study sites.

Patients in the study had no history of heart disease and had experienced a stroke or TIA (mini-stroke) within six months prior to trial enrollment. Patients were followed for an average of five years.

The SPARCL study was sponsored by Pfizer Pharmaceuticals.