From: Reuters
Published December 12, 2007 04:10 PM

Lipitor ups risk of bleeding stroke: study

By Will Dunham

WASHINGTON (Reuters) - Pfizer Inc's cholesterol fighter Lipitor may raise the small risk of the less common type of stroke, involving bleeding in the brain, in people who previously have had a stroke, researchers said on Wednesday.

The researchers said this risk must be weighed against the larger overall benefit provided by Lipitor in cutting the risk of the more common type of stroke and other cardiovascular conditions in people who already have had a stroke.

Lipitor, known generically as atorvastatin, is a multi-billion dollar seller for Pfizer. It is in a class of drugs known as statins.

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Writing in the journal Neurology, Dr. Larry Goldstein of Duke University Medical Center in North Carolina and colleagues said they did a more detailed analysis of results published last year showing that Lipitor reduced the overall risk of a second stroke.

They tracked 4,731 patients who had suffered a stroke or a mini-stroke, known as a transient ischemic attack, within the previous six months. Half were treated with Lipitor and the rest got a placebo. All were followed for an average of about 4-1/2 years.

Just over 2 percent of the patients who were taking Lipitor experienced a hemorrhagic stroke -- a type of stroke in which a blood vessel breaks and there is bleeding in or around the brain -- compared to 1.4 percent of those who got a placebo.

That represented about a 60 percent increase in risk, but the overall risk remained low, Goldstein's team said.

At the same time, according to the researchers, people treated with the drug had a 21 percent reduced risk for ischemic stroke, a more common variety of stroke involving a block in the blood supply to the brain.

The researchers found that other factors that raised the risk of brain hemorrhage in these patients included a previous hemorrhagic stroke; high blood pressure; and being a man.

"I do hope that the message gets across that there's a lot of benefit for patients being treated with Lipitor," Halit Bander, the head of Pfizer's Lipitor medical team, said in a telephone interview.

"There is overall benefit for patients who have had a prior stroke or a mini-stroke. Lipitor reduces your risk of getting your next stroke," Bander added.

"When you start breaking down -- if you've had a prior hemorrhagic stroke, it is up to the physician to look at your individual risk and benefit and to make that prescribing decision."

The risk for hemorrhagic stroke in patients taking this drug has not been found in those who have never had a previous stroke, the researchers said.

"Patients who take statins for coronary heart disease or coronary heart risk who have had no stroke have no increased risk for brain hemorrhage," Goldstein said in a telephone interview.

Pfizer funded the study. Goldstein has served as a paid consultant to Pfizer.

(Editing by Maggie Fox)

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