Cholesterol-Lowering Drug Reduces Strokes

January 23, 2001

A drug already being used to lower cholesterol and prevent heart attacks sharply reduced strokes in patients who already had heart disease, according to a study in the Jan. 23 issue of Circulation: Journal of the American Heart Association.

The drug, pravastatin, reduced stroke by 20 percent, compared to placebo, in patients with heart disease or high cholesterol, said Robert P. Byington, Ph.D., professor of public health sciences (epidemiology) at Wake Forest University School of Medicine, and colleagues in the Prospective Pravastatin Pooling Project.

The study "offers a major new way to lower the stroke rate," Byington said.

He said the drug reduced the risk of stroke over a wide range of cholesterol levels and among a wide spectrum of patients in pooled data from three similar clinical trials. The effect occurred primarily in the patients who already had coronary heart disease, where the reduction was 22 percent.

"For decades, there had been considerable doubt regarding the value of cholesterol- lowering in stroke prevention," Byington said.

"This was because strokes had only been weakly associated, if at all, with increased cholesterol levels in observational studies and because of the observed lack of benefit of lipid- [cholesterol-]lowering on strokes in the early cholesterol-lowering trials that used drugs that did not lower cholesterol as much as pravastatin," he said.

The Prospective Pravastatin Pooling Project began in 1992, before any of the three clinical trials were completed. The three trials - WOSCOPS (West of Scotland Coronary Prevention Study), CARE (Cholesterol And Recurrent Events) and LIPID (Long-term Intervention with Pravastatin in Ischemic Disease) totaled 19,768 participants from Scotland, the United States, Canada, Australia, and New Zealand.

Both CARE and LIPID separately reported fewer strokes among patients assigned to the pravastatin therapy than to those on placebo.

"Our analyses clearly demonstrate that pravastatin is more effective than the older, nonstatin lipid-lowering therapies in reducing stroke rates," Byington said. "The consistent reductions across the trials and patient subgroups are striking."

Pravastatin was also noted to have a beneficial effect in patients taking aspirin and in patients on blood-pressure-lowering drugs, two therapies already known to prevent strokes. "Our analyses show benefit on top of the known benefits of these drugs," Byington said.

Over the course of the three studies, a total of 267 patients on pravastatin had strokes, compared to 331 patients on the placebo, a statistically significant difference. The stroke rate declined from 6.5 per thousand per year in the placebo group to 5.2 per thousand in the pravastatin group. Most of the strokes were non-fatal; the number of fatal strokes was just about the same in both groups.

About 600,000 people suffer a non-fatal stroke each year in the United States, and these strokes are a leading cause of long-term disability and extensive rehabilitation.

Pravastatin already is used routinely to prevent heart attacks. It is marketed in the United States as Pravachol.

The Prospective Pravastatin Pooling Project was funded by Bristol Myers Squibb.


Contact: Robert Conn, Jim Steele or Mark Wright at (336) 716-4587

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