A large study has produced the strongest evidence yet that driving cholesterol down to very low levels offers additional protection against heart attacks and strokes, researchers reported yesterday.
The eagerly awaited study involving more than 10,000 at-risk patients showed that using high doses of powerful cholesterol-lowering drugs called statins to slash levels of "bad cholesterol" far below current targets can markedly reduce patients' risks.
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The study addresses one of the biggest debates in treating heart disease, the leading cause of death in the United States: How aggressively should doctors and patients use statins to reduce levels of low-density lipoprotein (LDL) cholesterol?
The findings may encourage more doctors to use the drugs to reach ultra-low LDL levels in potentially millions of patients and could lead to new official recommendations if the results of two other studies reach similar conclusions, experts said.
In the new study, researchers gave 10,001 patients whose arteries were already narrowed by heart disease either the standard dose of the statin Lipitor -- 10 milligrams -- or a much higher dose -- 80 milligrams.
After about five years, the cholesterol levels dropped in patients in both groups and their risk for heart attacks and strokes fell. But the LDL levels of those receiving the high dose plummeted the most, hitting an average of about 77 milligrams per deciliter of blood, compared with the standard target of about 100 for the other group. Those who received the high dose also were 22 percent less likely to have a heart attack, stroke or heart failure than those in the standard-dose group.
"We saw a clear benefit," said John. C. LaRosa of the State University of New York Health Science Center at Brooklyn, who led the study. The results, which are being published in the New England Journal of Medicine, were released early yesterday to coincide with a presentation of the data at an American College of Cardiology meeting in Orlando. The study was funded by Pfizer Inc., which makes Lipitor.
A growing body of evidence suggests that driving LDL to very low levels provides significant benefits, and the federal government's National Cholesterol Education Program said in July that those at high risk could consider pushing their levels lower. But the panel stopped short of making an outright recommendation, pending the results of three large studies. The new study is the first of those and the first large one to demonstrate a benefit in heart disease patients who are not experiencing acute problems.
Scott M. Grundy of the University of Texas Southwestern Medical Center at Dallas, who chaired the federal panel, welcomed the findings. But he said the panel probably would wait for the final two studies before issuing new recommendations, particularly because the new study did not show any drop in the death rate. In fact, there was also a small but puzzling increase in the overall number of deaths among those taking the high doses. In addition, the drugs can have side effects, including potentially life-threatening liver problems in a small number of patients.
"Until we get the results of those other two trials and can put it all together, a note of caution is still reasonable," Grundy said.
Other researchers disagreed, saying the evidence is clear enough to change medical practice now.
"There isn't any question left at this point that we should be more aggressive," said Eric J. Topol of the Cleveland Clinic.
Regardless of whether the recommendations are changed now or later, the new findings are likely to encourage more doctors to adopt the approach in the meantime, some experts said.
"This is going to affect millions of people in terms of the practical implications. A lot of primary care physicians are going to look at this result and say, 'Okay, it's time to start doing this,' " said Daniel J. Rader of the University of Pennsylvania.