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Hemorrhagic stroke in the Stroke Prevention by Aggressive Reduction in Cholesterol Levels study
L B Goldstein1, P Amarenco, M Szarek
1Duke University Medical Center, Durham, NC 27710, USA. golds004@mc.duke.edu
Neurology
|December 14, 2007
Summary
Atorvastatin increased hemorrhagic stroke risk, particularly in men and older patients. This risk was also elevated in patients with prior hemorrhagic stroke or Stage 2 hypertension, independent of treatment.
Area of Science:
- Neurology
- Cardiology
- Clinical Research
Background:
- The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study demonstrated atorvastatin's efficacy in reducing overall stroke risk.
- A post hoc analysis revealed an increased incidence of hemorrhagic stroke among patients treated with atorvastatin compared to placebo.
Purpose of the Study:
- To investigate the factors associated with hemorrhagic stroke risk in patients treated with atorvastatin.
- To explore the relationship between hemorrhage risk and treatment, baseline characteristics, blood pressure, and LDL cholesterol levels.
Main Methods:
- Utilized Cox multivariable regression analysis on data from the SPARCL trial.
- Examined baseline variables, including demographics, prior stroke/TIA type, blood pressure, and LDL cholesterol levels, in relation to hemorrhagic stroke events.
Main Results:
- Atorvastatin treatment (80 mg/day) was associated with a higher risk of hemorrhagic stroke (HR 1.68).
- Hemorrhagic stroke risk was significantly higher in patients with a history of hemorrhagic stroke (HR 5.65), men (HR 1.79), and with increasing age (HR 1.42 per 10 years).
- Stage 2 hypertension (JNC-7) at the last study visit prior to hemorrhage also increased risk (HR 6.19); no association was found with LDL cholesterol levels.
Conclusions:
- Hemorrhagic stroke occurred more frequently with atorvastatin, especially in patients with a history of hemorrhagic stroke, men, and older individuals.
- Stage 2 hypertension was identified as another risk factor for hemorrhagic stroke.
- Atorvastatin treatment did not disproportionately increase hemorrhagic stroke risk associated with these identified factors, and LDL cholesterol levels were not related to hemorrhage risk.
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