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| Haemorrhagic stroke in SPARCL study |
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December 2007
People taking cholesterol-lowering drugs such as atorvastatin after stroke may be at an increased risk of haemorrhagic stroke, a risk not found in patients taking statins who have never had a stroke. But researchers caution that the risk must be balanced against the much larger overall benefit of statins in reducing the total risk of a second stroke and other cardiovascular events when making treatment decisions.
Larry B. Goldstein, MD, from Duke University Medical Center, Durham, NC, and his colleagues explored the relationships between haemorrhage risk and treatment, baseline patient characteristics, most recent blood pressure, and most recent low-density lipoprotein (LDL) cholesterol levels before the haemorrhage.
In the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study, atorvastatin 80 mg/day reduced the risk of stroke in patients with recent stroke or TIA. For the study, the authors conducted a secondary analysis of the results of the clinical trial. The trial enrolled 4,731 people who had suffered stroke or transient ischaemic attack 1–6 months before and had no history of heart disease. Half of the participants received atorvastatin and half received placebo. The participants were then followed up for an average of four-and-a-half years. Posthoc analysis found this overall benefit included an increase in the number of treated patients suffering haemorrhagic stroke (n = 55 for active treatment vs n = 33 for placebo).
Of 4,731 patients, 67% had ischaemic strokes, 31% TIAs, and 2% haemorrhagic strokes as entry events. In addition to atorvastatin treatment (HR 1.68, 95% CI 1.09 to 2.59, p = 0.02), Cox multivariable regression including baseline variables significant in univariable analyses showed that the risk of haemorrhagic stroke was higher in those with haemorrhagic stroke as the entry event (HR 5.65, 95% CI 2.82 to 11.30, p < 0.001), in men (HR 1.79, 95% CI 1.13 to 2.84, p = 0.01), and increased with age (10-year increments, HR 1.42, 95% CI 1.16 to 1.74, p = 0.001). There were no statistical interactions between these factors and treatment. Multivariable analyses also found that having Stage 2 (JNC-7) hypertension at the last study visit before a haemorrhagic stroke increased the risk (HR 6.19, 95% CI 1.47 to 26.11, p = 0.01), but that the most recent LDL cholesterol level in those treated with atorvastatin had no effect.
"Although treatment of patients with a stroke or transient ischaemic attack was clearly associated with an overall reduction in the rate of second stroke, haemorrhagic stroke was more frequent in people treated with atorvastatin, in those with a prior haemorrhagic stroke, in men, and in those with uncontrolled hypertension," according to study author Larry B. Goldstein. "This risk of haemorrhagic stroke also increased with age."
The investigators concluded that haemorrhagic stroke was more frequent in patients treated with atorvastatin, those with a haemorrhagic stroke as an entry event, in men, and that the risk increased with age. Those with Stage 2 hypertension at the last visit before the haemorrhagic stroke were also at increased risk. There were no relationships between haemorrhage risk and baseline LDL cholesterol or most recent LDL cholesterol level in treated patients.
"Treatment with atorvastatin did not disproportionately increase the frequency of brain haemorrhage associated with these other factors. The risk of haemorrhage in patients who have had a transient ischaemic 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.
Reference:
Goldstein et al. Neurology 2007
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