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Aug. 9, 2006 -- StrokeStroke patients can reduce their risk of having a second stroke by taking high doses of a widely prescribed cholesterol-lowering drug, even if they don't have heart diseaseheart disease, according to a new study.
Researchers say the findings from the five-year, international trial, make it clear that aggressive treatment to lower cholesterol should be considered standard therapy for stroke prevention in people who have already had a stroke.
Patients who took 80 milligrams of the drug Lipitor each day for five years saw a 16% reduction in having another stroke compared with patients who took a placebo. Patients on the cholesterol-lowering drug also experienced a 35% reduction in serious cardiac events.
The study -- called the SPARCL trial -- was funded by Lipitor manufacturer Pfizer, Inc. Pfizer is a WebMD sponsor.
Global Study
Each year an estimated 15 million people worldwide suffer strokes, and 10 million will either die or remain permanently disabled as a result.
Aggressive cholesterol lowering with statin drugs (such as Lipitor, Zocor, Crestor, or Mevacor) is routinely recommended for patients who have had heart attacks and for those who have a very high risk for heart disease, such as people with diabetesdiabetes.
But it has not been clear if lowering "bad" LDL cholesterolLDL cholesterol is as beneficial for reducing risk in stroke patients without heart disease.
In an effort to answer this question, investigators recruited 4,731 recent stroke and TIA (transient ischemic attack or "ministroke") patients with no history of heart disease. About 60% of participants were men, and the average age was about 63 years old.
The trial included patients treated at sites in Africa, Australia, Europe, the Middle East, and North and South America. All of the patients had experienced either a stroke or TIA within the previous six months. Patients were followed for an average of five years.
Most of the patients were already being treated with aspirin or blood thinners (94%), and roughly two out of three were on blood-pressure-lowering drugs. The included participants had LDL levels from 100 mg/dl to no more than 190 mg/dl. Half the patients in the trial also took 80 milligrams of Lipitor every day and half took a placebo.
After five years of treatment, 265 of the 2,365 patients on Lipitor (11.2%) had had a fatal or nonfatal stroke, compared with 311 of the 2,366 patients (13.1%) who took a placebo.
The overall death rate was similar in the two groups, but significantly fewer patients taking Lipitor had heart attacks.
The study results appear in the Aug. 10 issue of the New England Journal of Medicine.
Benefits vs. Risks
Chicago neurologist K. Michael Welch, MB, ChB, who led the investigation, tells WebMD that the findings argue in favor of adding high-dose Lipitor to the regimen of drugs routinely recommended for strokestroke patients.
"The risk following a first stroke is very high, with 40% of patients having a second stroke within five years," he says.
Because the study included only Lipitor and is the first statin trial to include only stroke patients, Welch says it is not clear if other statin drugs would work as well to lower the risk of secondary stroke and heart attackheart attack in this population.
David M. Kent, MD, agrees that the study provides compelling evidence that most stroke patients should be placed on a statin.
But he tells WebMD that the SPARCL trial left many questions unanswered about the benefits vs. the risks of such treatment for specific patient groups.
Kent is an assistant professor of medicine specializing in health policy research at the Tufts-New England Medicine Center in Boston.
It is not clear, for example, if patients who have had strokes caused by the rupture of an artery within the brain benefit from the treatment, he says.
About one in five stroke patients has this type of stroke, known as a hemorrhagic stroke. Most patients have ischemic strokes, which are caused by a clot within an artery in the brain.
"I think it is clear that the default position should be to start patients who have had ischemic strokes on a statin, but this is not clear for hemorrhagic stroke patients," Kent says. Kent notes in his editorial that statins have anticlotting effects and that there was an increased risk for patients in the Lipitor group to have a hemorrhagic stroke.
Unanswered questions aside, Kent says the biggest threat for stroke patients is not overtreatment with a statin, but undertreatment. He makes the point in an editorial accompanying the study.
"In one recent study, even among [hospitalized stroke] patients who were eligible for statin therapy ? only a third had discharge medications that included statins," he wrote.
SOURCES: New England Journal of Medicine, Aug. 10, 2006; vol 336: pp. 549-559. Michael Welch, MB, ChB, president and CEO, Rosalind Franklin University of Medicine and Science, Chicago. David M. Kent, MD, Institute for Clinical Research and Health Policy Studies, Tufts- New England Medical Center, Boston.