Interrupting the drugs for even a few days can negatively impact recovery, study finds
MONDAY, Aug. 27 (HealthDay News) -- Hospitalized stroke patients who stop taking their cholesterol-lowering statin drugs -- even for a short time -- may increase their long-term risk of death and disability, researchers report.
The Spanish study found that withdrawing statins -- which include drugs like Crestor, Pravachol and Zocor -- in the first three days after a stroke raised a patient's risk of either dying or becoming physically dependant three months later by nearly fivefold, compared with patients who continued their statin regimen.
"This study is extremely important, because for the first time, it has demonstrated in a clinical trial that patients taken off of these drugs when they come to the hospital have a worse outcome," said Dr. Matthew Fink, chief of the division of stroke and critical care neurology at Weill Cornell Medical College in New York City.
Fink noted that prior research has already highlighted statins' protective effect, and that it's now common for physicians to immediately put stroke patients on statins, or maintain their usual statin use in the event of an attack. However, the drugs are not yet specifically approved for this stroke-specific use by the U.S. Food and Drug Administration.
Fink emphasized that doctors don't consider this "off-label" use of statins risky or dangerous.
The study, published in the Aug. 28 issue of Neurology, was led by Dr. Jose Castillo at the University of Santiago de Compostela.
According to the National Stroke Association (NSA), 80 percent of strokes are preventable, but the attacks are still the third leading cause of death in the United States. They are also the country's leading cause of adult disability.
A stroke results from a blockage of blood flow to the brain after a clot blocks either an artery or a blood vessel, the NSA says. Various degrees of brain damage can ensue, with effects ranging from temporary arm or leg weakness to full paralysis and loss of speech.
Statins are cholesterol-lowering drugs primarily prescribed as a chronic therapy for patients at risk for cardiovascular illness. The medication works by lowering the amount of so-called "bad" low-density lipoprotein (LDL) cholesterol in the bloodstream.
Recent research has indicated that statins may actually help prevent a stroke from occurring in the first place. As well, the study authors said evidence is mounting that the drugs help control inflammation. They may also possess antioxidant properties. Some studies have indicated that statins boost the immune system while preventing platelets from collecting, thereby preventing the formation of blood clots.
To explore statin therapy's role in improving post-stroke recovery, Castillo and his colleagues tracked the experience of 89 Spanish patients being treated in an acute stroke hospital unit.
All had already been prescribed statins prior to the onset of a stroke, and none had a post-stroke life expectancy of less than six months.
Between 2003 and 2005, the researchers randomly divided the stroke patients equally into two groups. One group continued to receive 20 milligrams of daily statins (regardless of prior dosage) in the first three days after their stroke, either orally or through a feeding tube. The other group stopped receiving statins over the same three-day post-stroke period.
On the fourth day, the group that had been placed on statin withdrawal resumed taking the drug, and all of the patients went on to continue taking the drug for at least three more months.
All patients were monitored through clinical and radiological evaluations (including MRIs) once a day for the duration of their hospital stay, and again three months following discharge.
In the end, Castillo's team found that patients who got statins in the first three days post-stroke fared much better than patients who did not.
While 60 percent in the non-statin group either died or become physically disabled and dependent at the three-month mark following their stroke, only 39 percent of the statin-taking group died or experienced a similar level of physical deterioration.
The risk of death and dependency among the non-statin group was even higher after adjusting for other contributing factors such as patient age and the severity of the stroke, the team reported.
Withdrawal of statins appears to undermine or block much of the brain protection afforded by prior use of the drug, the researchers speculate. Holding back the drugs might also impair vascular function and increase inflammation, the authors said.
Based on their findings, Castillo's team strongly encourage physicians not to withdraw statins from patients who have been taking the drug prior to a stroke. They also call for more research to explore whether giving statins to stroke patients who haven't tried them before might improve their long-term outcomes.
Fink said the study bolsters the notion that the approved role of statins should be expanded to include post-stroke treatment.
"I suspect that at some point, they'll be a request submitted to the FDA to add this to the list of indications [for statins], because the evidence keeps piling up that this is very beneficial," he said.
However, Dr. Eric Smith, an associate director of acute stroke services at Massachusetts General Hospital and an assistant professor of neurology at Harvard Medical School in Boston, said more research may still be needed. He said that that while the finding is interesting, only more research can clarify whether it is the statins that provide the post-stroke benefit, or if secondary factors are at play.
"It might be a good idea to maintain statins following a stroke in any patient the physician expects might survive the stroke, because they might help prevent damage," he said. "Studies have already been done in animals, and animals who got statins did better than those who didn't. But I think we need another human trial specifically looking at whether statins can improve outcomes in people after a stroke, even among patients who weren't taking statins before."
In a related study also published in this week's Neurology, a team led by Dr. Gail Li, of the University of Washington School of Medicine, Seattle, has found that statin use might curb Alzheimer's-linked brain changes.
The study, funded by the U.S. National Institute on Aging, focused on autopsy findings from the brains of 110 people over 65 who had donated their brains for research. The deceased had all been patients at the Seattle-based Group Health Cooperative Center for Health Studies.
Li's team found that people who had taken statin medications had fewer protein "tangles" in their brains -- a strong marker for Alzheimer's -- than people who had not taken the medications.
For additional information on post-stroke recovery and treatment, visit the National Stroke Association.
SOURCES: Eric Smith, M.D., M.P.H., associate director, acute stroke services, Massachusetts General Hospital, and assistant professor of neurology, Harvard Medical School, Boston; Matthew Fink, M.D., chief, division of stroke and critical care neurology, Weill Cornell Medical College, New York City; Aug. 27, 2007, statement, Group Health Cooperative Center for Health Studies; Aug. 28, 2007, Neurology
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