January 11, 2011 — The risk of statin therapy likely outweighs any potential benefit in patients with hemorrhagic stroke, a new study shows. Researchers warn therapy may increase the risk for recurrent hemorrhage.
"In an era when statins are in increasingly wide use for a range of indications, there may be a subset of patients where the risk of these agents outweigh the benefits," senior investigator Steven Greenberg, MD, director of hemorrhagic stroke research at Massachusetts General Hospital in Boston, told Medscape Medical News.
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| Dr. Steven Greenberg |
"We were somewhat surprised by the strength of the findings against statin use among survivors of lobar hemorrhage. Even among patients with high potential for cardiovascular events, statins were not projected to yield enough benefit to outweigh their hemorrhagic risks," he said.
The results are published online in the January 10 issue of the Archives of Neurology.
The team, led by Brandon Westover, MD, also at Massachusetts General, designed a Markov decision model to evaluate the risks and benefits of statin therapy. The main outcome was life expectancy measured as quality-adjusted life-years.
"We investigated how statin use affects this outcome measure while varying a range of clinical parameters, including hemorrhage location — deep vs lobar — ischemic cardiac and cerebrovascular risks, and magnitude of intracerebral hemorrhage risk associated with statins," explained the investigators.
Lobar Brain Regions Highest Risk for Recurrence
In survivors of lobar intracerebral hemorrhage without prior cardiovascular events, avoiding statins yielded a life expectancy gain of 2.2 quality-adjusted life-years compared with statin use. This net benefit persisted even at the lower 95% confidence interval of the relative risk of statin-associated intracerebral hemorrhage.
"Our computer model predicted worse outcome on statin treatment compared to off statin treatment in patients with past intracerebral hemorrhage," Dr. Greenberg said. "The results favoring no statin treatment were most clear-cut if the prior hemorrhage was in lobar brain regions, where the risk of recurrence is greatest."
In patients with lobar hemorrhage who had prior cardiovascular events, the researchers point out, the annual recurrence risk for myocardial infarction would have to exceed 90% to favor statin therapy.
Avoiding statin therapy was also preferable, although by a smaller margin, in both primary and secondary prevention settings for survivors of deep intracerebral hemorrhage.
Dr. Greenberg acknowledged to Medscape Medical News that decision-analysis modeling is no substitute for randomized clinical trials in deciding how patients should be treated. "Until such trials can be performed, however, our model provides at least some guidance for clinicians weighing the risks and benefits of statin treatment."
In an accompanying editorial, Larry Goldstein, MD, from Duke University in Durham, North Carolina, agreed that statin therapy risks likely outweigh any potential benefit in patients with intracerebral hemorrhage.
Until there are data to the contraryor warranted by specific clinical circumstances, he noted, the use ofstatins in patients with hemorrhagic stroke should be avoided.
The mechanism by which statins might increase the risk for hemorrhagic stroke is unknown, the study authors note. The association may be due to an increased risk for stroke among those with lower cholesterol levels or the potential anticlotting properties of statins.
This study was funded by the National Institutes of Health. The researchers have disclosed no relevant financial relationships. Editorialist Dr. Goldstein is a member of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial steering committee. He is a consultant for Pfizerand Merck.
Arch Neurol. Published online January 10, 2011.
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Cite this: Statins Not Recommended for Patients With Intracerebral Hemorrhage - Medscape - Jan 11, 2011.
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