Statins Can Boost Brain Hemorrhage Risk After Stroke

For most patients, small risk is outweighed by the benefits, experts say

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HealthDay Reporter

WEDNESDAY, Dec. 12, 2007 (HealthDay News) -- Some people taking statins after a stroke might face an increased risk of having a brain hemorrhage, a new study suggests.

But the risk of this life-threatening condition needs to be balanced against the benefit of statins in lowering the overall risk of a second stroke and heart attack, experts stress.

"There is a small but significant increased risk of brain hemorrhage among people who have had a previous stroke who take Lipitor, especially among those who have had a previous brain hemorrhage," said lead researcher Dr. Larry B. Goldstein, director of the Duke Center for Cerebrovascular Disease and the Duke Stroke Center at Duke University Medical Center. "If you don't have a history of stroke, then none of this matters."

Based on these findings, patients who have had a hemorrhagic stroke should not receive a statin to lower cholesterol, Goldstein said. "Having had a brain hemorrhage within the prior one to six months, one should be very cautious about starting a patient on a statin," he noted.

The report is published in the Dec. 12 online edition of Neurology.

In the study, Goldstein's group analyzed data from the Stroke Prevention with Aggressive Reduction in Cholesterol Levels (SPARCL) trial. In SPARCL, 4,731 people received 80 milligrams of Lipitor daily or placebo.

All those in the trial had had a stroke or a transient ischemic attack (TIA) one to six months before entering the SPARCL trial. None of the participants had a history of heart disease.

During an average of 4.5 years of follow-up, people taking Lipitor had a 16 percent reduction in second strokes and significant reductions in heart attacks. However, further analysis found an increase in the risk of brain hemorrhage.

Among those taking Lipitor, 2.3 percent had a hemorrhagic stroke compared with 1.4 percent of those taking placebo. On the plus side, there was a 21 percent reduction in ischemic stroke, the most common type of stroke, among those taking Lipitor, Goldstein noted.

Other factors that increased the risk of brain hemorrhage included being older, having had a previous hemorrhagic stroke, being male and having high blood pressure. In fact, people with severe high blood pressure had more than six times the risk of hemorrhagic stroke compared with people with normal blood pressure.

For most patients, statins such as Lipitor do help prevent strokes and heart attacks, Goldstein said. "For patients who have not had a stroke or TIA within the past six months -- there is no risk of hemorrhage," he said.

One expert agreed that patients who have had a hemorrhagic stroke should probably not be given statins.

"If there is any message that neurologists' will take home from this paper it is that 'I'm going to be a little more pensive about using statins in someone who has presented with a hemorrhage to the brain,'" said Dr. Wade Smith, director of the Neurovascular Service at the University of California, San Francisco.

Smith noted that the most important factor in preventing a second stroke is controlling blood pressure. "We as doctors and as patients need to be very aggressive about making our blood pressures normal after stroke," he said. "That's the most effective way of preventing a second stroke."

Another expert said the doses of Lipitor given in the trial were much higher than most people take.

"It is important to note that most patients on statins are on a much lower dose than that in the SPARCL study," said Dr. Majaz Moonis, director of the stroke prevention clinic at the University of Massachusetts Memorial Medical Center in Worcester. "In our own two independent retrospective study analyses including about 2,500 patients on lower doses of statins, more in line with what patients take, there was no evident increase risk of hemorrhage," he added.

Dr. Eric Smith, associate director of the Acute Stroke Services at Massachusetts General Hospital and Harvard Medical School, thinks statins shouldn't be used in patients who have had a hemorrhagic stroke.

"In my practice, when I see a patient with hemorrhagic stroke, I don't consider that to be an indication for starting a statin, based on the results of this trial," Smith said.

However, for patients who have had a hemorrhagic stroke and are at risk of having a heart attack, Smith does use statins, but at substantially lower doses than were used in SPARCL.

"I start with a low dose and see if that will get cholesterol down to the target level," Smith said. "When I reach the target level, I stop."

More information

For more on stroke, visit the American Stroke Association.

SOURCES: Larry B. Goldstein, M.D., director, Duke Center for Cerebrovascular Disease and Duke Stroke Center, Duke University Medical Center, Durham, N.C.; Wade Smith, M.D., Ph.D., director, Neurovascular Service, and professor, neurology, University of California, San Francisco; Eric Smith, M.D., M.P.H., assistant professor, neurology, and associate director, Acute Stroke Services, Massachusetts General Hospital and Harvard Medical School, Boston; Majaz Moonis, M.D., director, stroke prevention clinic, University of Massachusetts Memorial Medical Center, Worcester; Dec. 12, 2007, Neurology online

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