Lipitor Linked to Bleeding After Stroke

Experts: Most Patients Still Benefit From Taking Lipitor

From the WebMD Archives

Dec. 12, 2007 -- Stroke survivors who take high doses of a widely prescribed cholesterol-lowering drug appear to be at increased risk for stroke from bleeding in the brain, also known as hemorrhagic stroke. But the benefits of treatment still outweigh the risks for most, experts say.

Use of the statin drug Lipitor was associated with an increased risk of hemorrhagic stroke in the new analysis of a previously reported study.

But using Lipitor was a less significant risk factor for hemorrhagic stroke than having had a previous brain bleed or having uncontrolled high blood pressure, researchers say.

Previously reported findings from the same trial showed a significant reduction in fatal and non-fatal strokes of any kind and major coronary outcomes among stroke survivors taking high doses of Lipitor, principal author Larry B. Goldstein, MD, of Duke University Medical Center, tells WebMD.

"Like everything else we do in medicine, there are benefits and risks involved," he says. "Most patients who have had strokes appear to benefit from aggressive treatment with statins, but that may not be true for everyone."

(What do you think: Are the benefits worth the risks for you or your loved ones? Talk with others on the Stroke Support Group message board.)

Strokes and Statins

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 with a very high risk for heart disease, such as people with diabetes.

But it had not been clear if lowering "bad" LDL cholesterol benefited people who had survived strokes but did not have heart disease.

The Stroke Prevention with Aggressive Reduction in Cholesterol Levels (SPARCL) trial was designed to answer this question.

Published in August 2006, the trial showed a 16% reduction in fatal and nonfatal second strokes among stroke survivors who took 80 milligrams of Lipitor for about five years, compared with survivors in the placebo arm of the study.

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One troubling finding was an increased risk for brain bleeding among the Lipitor-treated patients. A total of 2.3% experienced this complication during the study period, compared with 1.4% of placebo-treated patients.

In the newly published analysis of the trial data, Goldstein and colleagues looked more closely at this outcome, finding Lipitor use to be independently associated with an increased risk of brain hemorrhage.

Other identified risk factors included advanced age, male sex, and having had a previous hemorrhagic stroke.

The analysis is published in the December issue of the journal Neurology.

Who Should Take Statins?

But even in patients with these risk factors, the benefits of aggressive statin treatment may still outweigh the risks, neurologist Lee Schwamm, MD, tells WebMD.

Schwamm is director of Acute Stroke Services at Massachusetts General Hospital and a spokesman for the American Heart Association (AHA).

"The (treatment-associated) effect was small compared to these other risks," he says.

He points out that only a small percentage of strokes -- about 17% according to the AHA -- are caused by ruptured blood vessels leading to brain bleeding. The rest, called ischemic strokes, occur when blood flow to the brain is blocked, usually by a clot.

"People who have had hemorrhagic strokes are usually at risk for ischemic stroke, so you can't say these people wouldn't benefit from this treatment," he says. "The key message is that patients with a history of hemorrhagic stroke should have a careful discussion with their doctor about the risks and benefits of this treatment."

A spokeswoman for Lipitor manufacturer Pfizer Inc. agrees.

"It is important for patients to discuss their individual risk factors with their doctor," Halit Bander, PhD, tells WebMD.

Can Cholesterol Be Too Low?

Goldstein says the latest analysis of the SPARCL results proved reassuring in several ways.

Very low LDL cholesterol levels had been linked to an increased risk for brain bleeds in several earlier, epidemiological studies.

"The hypothesis has been that we may be driving cholesterol too low with treatment," he says. "But in this study we saw no association between cholesterol lowering and brain hemorrhage."

And the data showed no evidence of an increase in brain bleeding linked to the use of blood-thinning drugs.

WebMD Health News Reviewed by Louise Chang, MD on December 12, 2007

Sources

SOURCES: Goldstein, L.B., Neurology, December 2007; online edition. Larry B. Goldstein, MD, Duke University Medical Center, Durham, N.C. Lee Schwamm, MD, vice chairman, department of neurology, Massachusetts General Hospital; associate professor of neurology, Harvard Medical School; spokesman, American Heart Association. Halit Bander, PhD, Global Medical Team Leader for Lipitor, Pfizer Inc. WebMD Medical News: "Stroke Patients Benefit from Lipitor."

© 2007 WebMD, Inc. All rights reserved.

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