Hemorrhagic stroke was more frequent in those treated with atorvastatin (Pfizer’s Lipitor) than in those with a hemorrhagic stroke as an entry event, in men, and increased with age, according to the study in Dec. 12 online issue of Neurology.
In the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study, L. B. Goldstein, MD, of Duke University Medical Center in Durham, N.C., and colleagues, noted that atorvastatin 80 mg/day reduced the risk of stroke in patients with recent stroke or transient ischemic attack (TIA). The post hoc analysis found the overall benefit included an increase in the numbers of treated patients having hemorrhagic stroke (55 patients for active treatment compared to 33 for placebo).
The researchers set out to explore the relationships between hemorrhage risk and treatment, baseline patient characteristics, most recent blood pressure and most recent low-density lipoprotein (LDL) cholesterol levels prior to the hemorrhage.
Of the 4,731 patients, 67 percent had ischemic strokes, 31 percent TIAs, and 2 percent hemorrhagic strokes as entry events. In addition to atorvastatin treatment, Cox multivariable regression including baseline variables significant in univariable analyses showed that hemorrhagic stroke risk was higher in those having a hemorrhagic stroke as the entry event, in men, and with age (10-year increments).
The authors did not note any statistical interactions between the factors and treatment. Multivariable analyses also found that having Stage 2 (JNC-7) hypertension at the last study visit before a hemorrhagic stroke increased risk, but there was no effect of most recent LDL-cholesterol level in those treated with atorvastatin.
In addition to the hemorrhagic stroke events related to Lipitor, the patients with Stage 2 hypertension at the last visit prior to the hemorrhagic stroke were also at increased risk.
The authors concluded that the treatment did not disproportionately affect the hemorrhagic stroke risk associated with the other factors. There were no relationships between hemorrhage risk and baseline low-density lipoprotein (LDL) cholesterol level or recent LDL cholesterol level in treated patients.