Patients with a history of brain hemorrhage may find that the risk of recurrence is much higher than the benefits they could gain from statins, researchers from Massachusetts General Hospital and Harvard Medical School, Boston, wrote in Archives of Neurology.

The authors explained that generally, statin use has been accepted as an effective way of significantly reducing stroke and heart disease risk. However, widespread use of the drug is a controversial subject.

The researchers wrote:

“A particular subgroup of patients for whom the advisability of statin use is unclear are those at high risk for intracerebral hemorrhage (or a stroke caused by bleeding within the brain). The reason for added concern is the increased incidence of intracerebral hemorrhage observed among subjects randomized to statin therapy in a clinical trial of secondary stroke prevention.”

M. Brandon Westover, M.D., Ph.D., wrote:

“Because intracerebral hemorrhage sufferers commonly have co-morbid [co-occurring] cardiovascular risk factors that would otherwise warrant cholesterol-lowering medication, it is important to weigh the risks and benefits of statin therapy in this population.”

A Markov decision model was used by the investigators to evaluate the risks and benefits. Simulated patients, based on previous research, were assigned to states that correspond to risk of disease, and could consequently experience a range of combination of events which might lead to the raised risk of stroke or heart disease, change in quality of life, or even death.

They wrote:

“Our analysis indicates that in settings of high recurrent intracerebral hemorrhage risk, avoiding statin therapy may be preferred. For lobar intracerebral hemorrhage [bleeding in the cerebrum] in particular, which has a substantially higher recurrence rate than does deep intracerebral hemorrhage, statin therapy is predicted to increase the baseline annual probability of recurrence from approximately 14% to approximately 22%, offsetting the cardiovascular benefits for both primary and secondary cardiovascular prevention.”

The benefits and risks of using statins were more evenly balanced for patients with intracerebral hemorrhage – a kind of stroke caused by bleeding deep inside the brain that has a low recurrence rate. The authors wrote “Consequently, the optimal treatment option may vary with specific circumstances.”

Scientists do not know why a hemorrhagic stroke is more likely among statin users with a history of brain hemorrhage. Perhaps, a drop in cholesterol levels, or potential anti-clotting properties of statins increase their risk of brain bleeding, the authors suggest.

The scientists concluded:

“In summary, mathematical decision analysis of the available data suggests that, because of the high risk of recurrent intracerebral hemorrhage in survivors of prior hemorrhagic stroke, even a small amplification of this risk by use of statins suffices to recommend that they should be avoided after intracerebral hemorrhage. In the absence of data from a randomized clinical trial (ideally comparing various agents and doses), the current model provides some guidance for clinicians facing this difficult decision.”

Arch Neurol Published online January 10, 2011. doi:10.1001/archneurol.2010.356.

Larry B. Goldstein, M.D., of Duke University and Durham VA Medical Center, Durham, N.C., in an accompanying editorial, wrote:

“The question prompting the decision analysis model reported by Westover et al epitomizes a common conundrum faced by clinicians – the need to make a therapeutic decision for a given patient in the absence of guidance from specific, high-quality clinical trial data.

In this case, exploratory data from two clinical trials (Heart Protection Study and SPARCL) suggest, but do not prove, a statin-associated increased risk of brain hemorrhage that may reduce the overall benefit of treatment in patients with a history of cerebrovascular disease.”

Dr. Goldstein added that the available data are..:

“..generally consistent with the conclusion of the decision analysis -the risk of statin therapy likely outweighs any potential benefit in patients with (at least recent) brain hemorrhage and should generally be avoided in this setting,” Dr. Goldstein writes. “Until and unless there are data to the contrary, or warranted by specific clinical circumstances, the use of statins in patients with hemorrhagic stroke should be guided by the maxim of nonmaleficence – Primum non nocere.”

Arch Neurol. Published online January 10, 2011. doi:10.1001/archneurol.2010.349.

Written by Christian Nordqvist