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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.)
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.
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.
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.