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Do "statins" increase the risk of hemorrhagic stroke?

Susan Fagan, Pharm.D., BCPS, FCCP
February, 2008

Reference: Goldstein LB, Amarenco P, Szarek M, Callahan A 3rd, Hennerici M, Sillesen H, Zivin JA, Welch KM; On behalf of the SPARCL Investigators. Hemorrhagic stroke in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels study. Neurology. 2007 Dec 12 [Epub ahead of print].

This is the report of a posthoc analysis of data from the recently published SPARCL trial, in which atorvastatin 80 mg daily was found to significantly reduce the risk of recurrent stroke (16% RRR) when initiated within 6 months of the initial event. The study was very important because, although there was plenty of evidence that statins reduced stroke in patients with coronary artery disease, there was no clinical trial data to support a reduction in recurrent stroke in patients with no history of coronary disease. Most stroke experts have adopted a broad use of statins for secondary prevention in patients with ischemic stroke and many now recommend the high dose (80 mg) of atorvastatin routinely. There is a lingering concern, however, in that this high dose therapy was shown to cause a significant increase in hemorrhagic stroke (2.3% vs. 1.4%). This paper reports the results of analyses to determine the patient characteristics associated with increased risk of hemorrhagic stroke.

The factors significantly associated with hemorrhage in multivariable regression were: atorvastatin treatment, hemorrhage as the entry event (yes, this was allowed but represented only 2% of the study population!), male gender, increased age, and Stage II hypertension (SBP > 160 mmHg or DBP > 100 mmHg.). The largest risk was associated with having a previous hemorrhagic stroke. Importantly, there was no relationship of hemorrhage with the degree of LDL lowering, suggesting that it was NOT a dose effect. Somewhat surprisingly, hemorrhagic stroke also did not correlate with the use of anticoagulants or antiplatelet therapy.

It is important to remember that the statin therapy reduced ALL stroke significantly, despite an increase in hemorrhagic stroke. By restricting statin therapy in patients with prior hemorrhagic stroke and uncontrolled blood pressure, it is likely that this therapy will have a large positive impact on stroke patient outcomes.

Full disclosure: I am a consultant for, and receive grant funds from, Pfizer.

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