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U.S. Panel Supports Widespread Use of Cholesterol Drugs

By: Gina Kolata
The New York Times, May 17, 2001


Impressed by mounting evidence that deaths from heart disease could be significantly reduced with aggressive treatments, a national panel recommended yesterday that millions more Americans take powerful cholesterol-lowering drugs or immediately alter their diets. 

The group, sponsored by the federal government, proposes nearly tripling the number of adults who should be taking cholesterol-lowering drugs and raising by 25 percent the number who should be on a cholesterol-lowering diet.

"We want to recommend more aggressive treatment to people who are at very high risk," said Dr. James I. Cleeman, the coordinator of the group that issued the guidelines, the National Cholesterol Education Program of the National Heart, Lung and Blood Institute.

"And," he added, paraphrasing Shakespeare, "there are more of them out there than are dreamt of in your philosophy."

The recommendations increase the number of Americans who are candidates for cholesterol-lowering drugs to about 36 million from the 13 million under the old guidelines. The number who should be on cholesterol-lowering diets is raised to 65 million from the current 52 million.

The recommendations, announced yesterday in Washington, were also posted on the Web page of the institute (nhlbi.nih.gov), a division of the National Institutes of Health. An executive summary of the report was published in today's issue of The Journal of the American Medical Association.

Dr. Claude Lenfant, director of the institute, said that if the American public took the guidelines seriously, heart disease could slip from its ranking as the nation's leading cause of death. 

"It would no longer be the No. 1 killer," he said.

More than a million Americans have heart attacks each year, and a half-million die from heart disease.

The guidelines are intended to simplify the process by which people determine whether they are at risk for heart disease. The well-known cholesterol levels remain largely the same, but a formula has been added to them that clearly estimates an individual's chance of having a heart attack in the next 10 years. It calculates risk for men and women according to age, cholesterol level, smoking status and blood pressure.

The panel urged that people whose risk was 20 percent or more be treated as aggressively as patients who had just had a heart attack. That almost always means the immediate use of cholesterol-lowering treatments, most often statins — powerful drugs that can slash cholesterol levels by blocking a liver enzyme crucial to cholesterol production. The panel also urged these high-risk people to follow cholesterol-lowering diets, exercise and lose weight. 

People with diabetes are now automatically put into the high-risk category. 

Previously, diabetes was considered simply another risk factor, rather than a danger sign so glaring that it was as if the person had already had a heart attack. 

"The medical community is pretty well attuned to the fact that if you had a heart attack, you are at high risk for having another one," Dr. Cleeman said. "But what is not well known is that there are other people who are at just as high risk."

Dr. Valentin Fuster, a cardiologist at the Mount Sinai School of Medicine in New York and a past president of the American Heart Association, noted that this aspect of the guidelines was a pronounced change.

"You are targeting a population that has never had a heart attack," Dr. Fuster said.

Those people used to be handed a diet to start and given more modest goals for cholesterol reduction. Now, he said, the guidelines told doctors to "go in aggressively, as aggressively as in patients who already had heart disease."
Another change was in how to treat people who have had a heart attack, said Dr. Michael Lauer, who directs clinical research in cardiology at the Cleveland Clinic Foundation and is a co-author of an editorial accompanying the guidelines in The Journal of the American Medical Association.

Heart-attack patients with high cholesterol levels used to be put on a diet. After several months they would have their cholesterol re- checked, Dr. Lauer said. 

"If they had not responded, they would be put on medication," Dr. Lauer said. "But in reality, they would be given that diet and in the vast majority of cases their cholesterol would not change and they would not be put on medication. This has been documented again and again. The new guidelines say go ahead and put them on drugs straight off."

Diet, exercise and weight reduction are the primary recommendations only for people at lower risk, with elevated cholesterol levels but with less than a 20 percent chance of having a heart attack in the next decade.

But even some of those people should take drugs, depending on their cholesterol levels, according to the guidelines. Some with particularly high levels of the type of cholesterol, LDL cholesterol, that injures blood vessel walls, might consider taking a drug.

The last time the national panel issued cholesterol treatment guidelines was in 1993. So much has changed since then, heart disease researchers said, that those much less aggressive guidelines now seem to be of a different era.

"There was this enormous dissent 10 years ago," Dr. Lauer said. Many medical experts took issue with the idea of aggressively treating patients like older people or people who had no symptoms of heart disease but whose cholesterol levels were elevated. "It was felt that the evidence was not there to support this very aggressive management." 

But the completion of at least five major clinical trials, most using statins to sharply lower cholesterol levels, proved the skeptics wrong, researchers said. They showed conclusively that reducing cholesterol levels could lower death rates and prevent heart attacks. 

"The driving force is the data that have been accumulating over the past eight years and that have been so compelling," Dr. Lenfant said. 
Dr. Lauer added that "the whole cholesterol picture has really changed. There now is no doubt that cholesterol reduction saves lives and prevents heart attacks and it probably prevents bypass surgery and angioplasty. Now the question is, How do we best implement it?"

He urged that doctors identify patients who need diets or drugs and impress upon them the necessity of following those treatments.

Dr. Cleeman said the 27 panel members and consultants who developed the guidelines and the more than 40 groups that reviewed them stressed the importance of getting the message out to doctors and the general public as quickly as possible. 

While some experts involved in formulating and reviewing the guidelines have consulted for drug companies, the groups of reviewers and consultants were diverse and represented public health organizations, medical groups, nursing associations and consumer groups as well as an array of federal agencies.

"In our previous experience with guidelines in every field, merely saying, `Here's a guideline,' does not equate with having them implemented," Dr. Cleeman said.

"We are taking measures to try to encourage the speedy adoption of these guidelines, virtually as we release them," he added, citing steps like providing summaries that doctors can keep on their desks and programs that can be put on personal organizers that calculate heart- disease risk and treatment recommendations. 

Statins are expensive, however. Even one of the cheapest, Merck & Company's lovastatin, costs $2.01 a day wholesale, said Marc Boston, a Merck spokesman. Lovastatin's patent is due to expire on June 15, however, paving the way for less costly generic forms. 
But heart disease experts say the benefits of putting more Americans on the drugs are well worth the price. 

"These statins are amazing drugs," said Dr. Scott M. Grundy, director of the Center for Human Nutrition at the University of Texas Southwestern Medical Center in Dallas and chairman of the panel that wrote the new cholesterol guidelines.

"When you say you can't put that many people on drugs, you've got to balance that against the tremendous devastation of coronary heart disease," Dr. Grundy added.