Wider Guidelines Urged for Statins*

Prescribing statins for people with type 2 diabetes irregardless of cholesterol levels.

These findings should tear up the rule-book on statin prescribing," says Richard Horton, editor of the Lancet. "This marks a major conceptual shift in our understanding of the prevention of heart disease."

July 5, 2002 -- Imagine a simple pill saving hundreds of thousands of people from heart attack and stroke across the globe. That's what a major new study says would happen if cholesterol-lowering statin drugs were prescribed to the millions of at-risk individuals who could benefit from them.

Researchers say prescribing statins to a wider range of people could reduce heart attack and stroke rates by at least a third. Until now, statins have been primarily used to treat people who have high cholesterol levels.

But the results of the British Heart Protection Study (HPS) show statins also reduce risks for people with diabetes, narrowing of the arteries (the major cause of heart disease), and a history of stroke. Even more importantly, researchers say the inexpensive medications can also protect people with normal or low cholesterol levels. And they work as well in women and the elderly as they do in men and younger people.

"The clear message from this study is: 'Treat risk -- not cholesterol level,'" says Charles George, medical director of the British Heart Foundation, in a news release. He says the results of the study call for a review of the guidelines on statin use issued by government and professional organizations, such as the U.S. National Institutes of Health and American Heart Association.

Researchers say guidelines should be changed so that a statin is considered for use in anyone at increased risk for heart attack or stroke regardless of cholesterol level.

The study examined the effects of statin use in more than 20,000 men and women between the ages of 40 to 80 with various risk factors for heart disease. After five years, the risk of heart-related deaths was reduced by 18% among those who received statins. People who took statins were also 25% less likely to suffer a nonfatal heart attack or stroke or require heart bypass surgery.

"HPS shows unequivocally that statins can produce substantial benefit in a very much wider range of high-risk people than had been previously thought," says study author Rory Collins of the University of Oxford Clinical Trial Unit, in the release.

"If now, as a result, an extra 10 million high-risk people were to go onto statin treatment, this would save about 50,000 lives a year -- that's a thousand each week," says Collins. "In addition, this would prevent similar numbers of people from suffering non-fatal heart attacks or strokes."

The complete report appears in the July 6 issue of The Lancet.

Richard Horton, editor of The Lancet, says, "These findings should tear up the rule book on statin prescribing. They are the most important and far-reaching results for the treatment and prevention of heart disease and stroke that we have seen in a generation.

"Previously there has been concern that statins have been used too much; after the results of HPS have been published there should be concern that they may not be used enough in the future," says Horton.

Previous studies on statins have not included many women or people over the age of 70. But researchers say those groups were well represented in this study, and statin use was safe and effective for all.

The study also looked at the effect of using antioxidant supplements, such as vitamins E and C and beta-carotene, in people at risk for heart disease. But researchers found taking these supplements did not provide any significant reduction in risk for heart attack, stroke, cancer, or other major events.  Statin drugs include Pravachol, Lescol, Lipitor, Zocor.