Treatment with high doses of Lipitor (also called atorvastatin) reduces the overall risk of stroke and cardiovascular events in patients who have experienced a recent stroke or “mini-stroke,” new research shows.

While Lipitor was associated with a reduced risk of ischemic strokes - the type caused by a blood clot - it was also associated with an increased risk of Hemorrhagic strokes - the type caused by bleeding in the brain.

Still, there was an overall benefit, and the drug did not seem to increase the risk of fatal Hemorrhagic strokes.

Previous reports have shown that statins cut the risk of stroke in patients at risk for cardiovascular disease. However, their value in preventing strokes in patients who have experienced a recent stroke or mini-stroke was unclear.

In the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial, 4731 patients with a stroke or mini-stroke in the previous 6 months were randomized to receive Lipitor 80 mg or placebo per day. At enrollment, the subjects had LDL cholesterol levels between 100 and 190 mg/dL and had no known heart disease.

Dr. Michael Welch, from Rosalind Franklin University of Medicine and Science in Chicago, and colleagues report their findings in The New England Journal of Medicine this week.

During the study, the average LDL cholesterol levels in the Lipitor and control groups were 73 and 129 mg/dL, respectively.

After 4 to 7 years of follow-up, the stroke rate in the Lipitor group was 11.2 percent compared with 13.1 percent in the control group, a risk reduction of 16 percent. A total of 218 ischemic and 55 Hemorrhagic strokes were seen in the Lipitor group compared with 274 ischemic and 33 Hemorrhagic strokes in the control group.

Compared with placebo, Lipitor use cut the risk of major cardiovascular events by 20 percent, which corresponds to an absolute reduction in risk of 3.5 percent

Lipitor use did not affect overall mortality: 216 patients died in the Lipitor group versus 211 in the placebo group. Although the rates of serious side effects were similar in each group, Lipitor was more often linked to elevated liver enzymes.

In a related editorial, Dr. David M. Kent, from Tufts-New England Medical Center in Boston, comments that “the SPARCL trial is likely to add to the gathering momentum favoring the promotion of ischemic stroke to a ‘coronary heart disease risk equivalent’, the adoption of statin therapy into guidelines for treatment of ischemic stroke, the enforcement of statin therapy on discharge after a stroke as a ‘quality indicator’, and the inclusion of statins in preprinted stroke orders to improve adherence by physicians.”

SOURCE: The New England Journal of Medicine, August 10, 2006.