Cholesterol Drug Is Found to Cut Risk of Repeat Stroke

Offering a new way to treat stroke patients, researchers reported Wednesday that high doses of a cholesterol-lowering statin drug could reduce the risk of another attack and strokerelated death.

The statin Lipitor lowered the risk of another stroke 16% and reduced fatal strokes 41%, according to the study, published in the New England Journal of Medicine.

Stroke kills 160,000 Americans each year, making it the third leading cause of death in the U.S., behind heart disease and cancer. Two of five stroke patients have a second attack within five years.

Although the study looked only at Lipitor, some experts said large doses of other statin drugs could have the same effect.

“This is a clear demonstration of the benefits of taking a statin under these circumstances,” said Dr. Steven Nissen of the Cleveland Clinic in Ohio, a cardiac specialist and statin researcher who was not involved in the study.

In an editorial accompanying the report, Dr. David M. Kent of Tufts-New England Medical Center in Boston said a daily dose of statins would now probably become standard care for certain classes of stroke patients.

The study, funded by Lipitor maker Pfizer Inc., showed the greatest benefits to patients who suffered strokes caused by clots or blockages that reduce blood flow to the brain, known as ischemic strokes, which account for 88% of all strokes.

But patients recovering from a less common form of stroke caused by bleeding in or near the brain, known as hemorrhagic strokes, did worse on Lipitor -- a finding some experts said was cause for concern.

Doctors, however, said the problem could be avoided by restricting the use of statins to ischemic stroke patients.

Although Kent, in his editorial, described the improvements as “modest,” he said the benefits were still compelling.

“The greatest current risk to patients with ischemic stroke vis-a-vis statins remains gross under-treatment,” wrote Kent, who has received Pfizer funding in the past.

The study was the latest to find new uses for cholesterol-lowering drugs. Statins have been shown to cut the risk of cardiovascular disease and heart attack, and a recent study found that they might prevent cataracts. Clinical studies are investigating whether statins can protect against some cancers.

An estimated 20 million Americans take a statin to prevent excessive cholesterol from forming artery blockages.

For all their benefits, statins are not without risk. The drugs can cause muscle weakness and raise liver enzymes, said Dr. Bruce A. Perler of Johns Hopkins University, a vascular surgeon who performed a recent statin study and was not involved in this study.

Doctors have long surmised the benefits of statins for stroke patients because of data from numerous large studies that looked at the drugs’ specific benefits for heart patients.

But part of the problem in coming to a clear determination has been the complex nature of strokes, which can have a variety of causes. Small pieces of fatty material or calcium can break off from an artery wall and block the tiny vessels leading to the brain. Vessels can be blocked by blood clots from injury or disease. High blood pressure can burst tiny vessels.

Also, large-scale studies of diverse patient groups have failed to find a stroke benefit in statins for people who did not have heart disease, and no studies have been done solely on stroke patients to settle the matter.

“Until today, we didn’t know if there was a reason for a person who had a stroke to be on a statin,” said Dr. Robert Adams, a spokesman for the American Stroke Assn. Adams, a neurologist at the Medical College of Georgia, said the association was likely to review its treatment guidelines, which list statins as an option but stop short of recommending them.

The latest study involved 4,731 patients at 205 medical centers in the U.S. and Europe. Half received Lipitor and the rest were given a placebo.

All the Lipitor patients got the maximum allowed dosage of 80 milligrams a day. The typical statin dosage for heart patients is 10 to 40 mg a day.

Most patients were also given the standard stroke treatment of blood pressure medicine and aspirin to prevent blood clots. All patients entered the trial within six months of having a stroke and were followed for five years.

During the study, 265 of the patients on Lipitor, or 11.2%, had another stroke, compared with 311, or 13.1%, of those on a placebo.

Although the difference seems small, Adams said, it comes in addition to the benefits from the standard treatments all the patients received.

There were no statistically meaningful differences in the overall death rates between the two groups, but when researchers looked only at stroke deaths, the Lipitor group benefited. There were 24 fatal strokes, or 1%, in the Lipitor group, compared with 41, or 1.7%, of patients taking a placebo.

But 55 patients on Lipitor, or 2.3%, suffered hemorrhagic strokes, compared with 33 patients in the placebo group, or 1.4%, a difference that some researchers attributed to the ability of statins to inhibit formation of blood clots that could seal a rupture of vessels in the brain.

Researchers were uncertain why statins helped prevent ischemic strokes. Dr. K. Michael Welch of Rosalind Franklin University of Medicine and Science in Chicago, who led the study, said there was probably a combination of factors, including the drug’s ability to slow cholesterol buildup in arteries, reduce blood vessel inflammation and prevent the formation of blood clots.

The Lipitor patients had the added benefit of having one-third fewer heart attacks and lower cholesterol levels, researchers said.