People taking cholesterol-lowering drugs such as
atorvastatin after a stroke may be at an increased risk of hemorrhagic stroke,
or bleeding in the brain, a risk not found in patients taking statins who have
never had a stroke. The research is published in the Dec. 12, 2007, online
issue of Neurology, the medical journal of the American Academy of Neurology.
For the study, researchers conducted a secondary analysis of the
results of the Stroke Prevention with Aggressive Reduction in
Cholesterol Levels (SPARCL) clinical trial. The trial enrolled 4,731
people who were within one to six months of having had a stroke or
transient ischemic attack, or mini-stroke, and with no history of heart
disease. Half of the participants received atorvastatin and half
received a placebo. The participants were then followed for an average
of four and a half years.
Overall, treatment was associated
with a 16-percent reduction in total stroke, the study's primary
endpoint, as well as significant reductions in coronary heart events.
However, secondary analysis found that the overall reduction in stroke
included an increase in the risk of brain hemorrhage. Of those people
randomized to atorvastatin, the study found 2.3 percent experienced a
hemorrhagic stroke during the study compared to 1.4 percent of those
taking placebo. The study also found there was a 21-percent reduction
in ischemic stroke, a more common type of stroke involving a block in
the blood supply to the brain, among people taking atorvastatin.
factors were also found to increase the risk of brain hemorrhage. For
example, those who had experienced a hemorrhagic stroke prior to the
study were more than five times as likely to suffer a second stroke of
this kind. Men were also nearly twice as likely as women to suffer a
hemorrhagic stroke. People with severe high blood pressure at their
last doctor's visit prior to the hemorrhagic stroke had over six times
the risk of those with normal blood pressure.
treatment of patients with a stroke or transient ischemic attack was
clearly associated with an overall reduction in a second stroke,
hemorrhagic stroke was more frequent in people treated with
atorvastatin, in those with a prior hemorrhagic stroke, in men and in
those with uncontrolled hypertension," according to study author Larry
B. Goldstein, MD, with Duke University Medical Center in Durham, North
Carolina, and Fellow of the American Academy of Neurology. "This risk
of hemorrhagic stroke also increased with age."
with atorvastatin did not disproportionately increase the frequency of
brain hemorrhage associated with these other factors. The risk of
hemorrhage in patients who have had a transient ischemic attack or
stroke must be balanced against the benefits of cholesterol-lowering
drugs in reducing the overall risk of a second stroke, as well as other
cardiovascular events," said Goldstein.