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Daily high-dose atorvastatin appears to cut the risk of stroke in patients who have had a recent stroke or transient ischemic attack, according to Dr. Pierre Amarenco of Denis Diderot University, Paris, and his associates in the SPARCL trial.

The treatment also was seen to substantially reduce the risk of cardiovascular events in these patients, who had no known heart disease at entry into the study but who did have LDL cholesterol levels of 100-190 mg/dL before the treatment commenced (N. Engl. J. Med. 2006;355:549-59).

"On the basis of our data, 46 patients would need to be treated for 5 years to prevent one stroke, 29 patients to prevent one major cardiovascular event, and 32 patients to avoid one revascularization procedure," Dr.Amarenco and his associates reported.

These results support a change in clinical guidelines: Stroke and TIA should be considered a "coronary heart disease risk equivalent," and atorvastatin therapy should commence soon after a stroke or TIA occurs, the researchers added.

The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial, which was funded by Pfizer Inc., was specifically designed to determine whether using high-dose (80 mg) atorvastatin treatment would decrease the stroke risk in those people who had an ischemic or hemorrhagic stroke or TIA within the preceding 6 months.

A total of 4,731 subjects were enrolled in the SPARCLstudy that was carried out at 205 research centers located throughout the United States and in Europe between the years 1998 and 2001.

These study subjects were followed until spring 2005.

Each of the subjects was randomly assigned to receive either daily atorvastatin or placebo.

They were allowed to take other cardiovascular medications, including open-label statins; aspirin or other antiplatelet drugs; ACE inhibitors; dihydropyridine derivatives; beta-blockers; angiotensin receptor antagonists; or vitamin K antagonists.

Within 1 month of study entry, patients receiving atorvastatin showed a 53% decrease in LDL cholesterol level.

After an average of 4.9 years of follow-up, stroke had occurred in 265 subjects in the atorvastatin group, compared with 311 in the placebo group, a 2.2% absolute difference.

"Atorvastatin was associated with a 16% relative reduction in the risk of fatal or nonfatal stroke," Dr. Amarenco and his associates said.

The use of atorvastatin was also found to decrease the 5-year risk of other major cardiovascular events seen in this study, with a 3.5% absolute difference found which resulted in a 20% relative reduction in risk, according to the researchers.

There were no significant differences seen between the groups in the incidence of serious adverse events reported.

Atorvastatin appeared to raise the risk of nonfatal hemorrhagic stroke, but the overall benefit of the treatment outweighed this "small" risk, according to the researchers.

"The small number of patients with brain hemorrhage at entry into our study precludes any meaningful conclusions regarding the relative risks and benefits of statin treatment in this population," they added.

In an editorial comment accompanying this report, Dr. David M. Kent of Tufts-New England Medical Center, Boston, stated that it was important to remember that the rate of stroke was relatively low in this study, and that the absolute benefit of treatment seen "was relatively modest."

It also "is important to note that patients with atrial fibrillation and other cardiac sources of emboli were excluded from the trial, presumably since cardioembolic strokes are less likely than other types of ischemic stroke to be responsive to cholesterol-lowering agents.

"This raises the issue of whether the SPARCL results apply to the roughly 1 in 5 ischemic strokes that are cardioembolic in origin," he said (New Engl. J. Med. 2006;355:613-5).

In addition, although atorvastatin caused a "small" rise in the absolute risk of hemorrhagic stroke, the relative risk was increased by 66%--"an effect that is likely to be of some import among patients presenting with hemorrhagic stroke," Dr. Kent said.