Health Officials Urge Sharply Lower Cholesterol Levels
Federal health officials today sharply reduced the desired levels of cholesterol for Americans who are at moderate to high risk for heart disease.
The new recommendations call for treatment with cholesterol-lowering drugs for millions of Americans who had thought their cholesterol levels were fine. For people at the highest risk, they suggest that the target level of L.D.L. — the type of cholesterol that increases the likelihood of heart disease — should be less than 100. That is 30 points lower than previously recommended.
For people at moderately high risk, lowering L.D.L. to below 100 with medication should be seriously considered, the report said. The advice for people at low risk remains unchanged.
The recommendations were published today in the journal Circulation and endorsed by the National Heart, Lung and Blood Institute, the American Heart Association, and the American College of Cardiology. The authors said the change was prompted by data from five recent clinical trials indicating that the current cholesterol goals were not aggressive enough.
The recommendations, which modify guidelines set by the government only 2 1/2 years ago, will increase by a few million the number of Americans who meet the criteria for therapy with the powerful cholesterol-reducing drugs called statins, and many people who are already taking the medications will be advised to increase their doses.
Under the old guidelines, about 36 million people in this country should be taking statins, said Dr. James Cleeman, coordinator of the National Cholesterol Education Program. But only about half that number actually do so.
In the report, the health officials addressed three questions: When are statins merely a sensible option? When are they imperative? And how aggressively should patients be treated? The recommendations focus on the levels of L.D.L., rather than total cholesterol levels, because L.D.L. is the target of cholesterol-lowering therapies.
One change applies to people at moderately high risk — defined as having risk factors like age, high blood pressure or smoking that confer a 10 to 20 percent chance of suffering a heart attack in the next decade. Under the new recommendations, doctors now have the option of prescribing drug therapy for such patients if their level of L.D.L. cholesterol is 100 or higher, the report says, and a level of below 100 can be set as a goal.
Previously, doctors were advised to prescribe statins to moderately high risk patients only if the patients' L.D.L. levels were above 130, and the treatment was considered effective if L.D.L. levels fell below 130.
For example, following the new advice, a 57-year old nonsmoking man who has an LDL of 115 and whose blood pressure, with medication, is 130, could now receive drug treatment. Under the old rules, he would not have been treated.
The recommendations also call for more aggressive treatment of people at high risk, that is, with established heart disease, diabetes, or other conditions that give them a greater than 20 percent chance of having a heart attack in the next decade. In such cases, when L.D.L. levels are above 100, doctors should always recommend drug treatment, the report said, and no longer have the option of not prescribing the medications.
The previous advice said that drug treatment was only imperative in high risk people when their L.D.L. exceeded 130.
The report did not change the advice for people whose cholesterol levels are above 130 but who have no other risk factors for heart disease. Statins are seldom prescribed in such cases. (A risk calculator is available on the heart, lung and blood institute's Web site, http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof).
Millions of Americans will be affected by the new advice, said Dr. Christie M. Ballantyne, the director of the Center for Cardiovascular Protection at Baylor College of Medicine. Citing national data, he said that among the more than 28 million Americans at high risk, at least 8 million have L.D.L. levels of 100 to 129.
The recommendations also call for more intensive drug treatment of both moderately high and high risk patients, telling doctors that the goal should be to reduce patients' L.D.L. levels by 30 to 40 percent, no matter what the initial levels were.
"There is some evidence that physicians were using so-called starter doses of statins, and then not upping the dose when that did not produce enough L.D.L. lowering," Dr. Cleeman said. "We are saying, `Don't just drop their L.D.L. a few percentage points. Drop it by 30 or 40 percent so they will get real benefit.' "
For example, Dr. Cleeman said: "If you have someone who starts at an L.D.L. level of 115, don't just give a small dose of a statin to get it to 99. Give a dose for a 30 to 40 percent reduction."
Perhaps the report's most surprising recommendation concerns the goal that doctors might set for L.D.L. levels in their patients at highest risk, those with established heart disease plus another condition like diabetes, smoking, high blood pressure, or a recent heart attack. For those patients, the report said, there is a therapeutic option to drive the L.D.L. level to a breathtaking low level — below 70.
The term, "therapeutic option," was used, Dr. Cleeman said, because while the advice is suggested by recent clinical trials, the evidence is not quite iron clad.
"The evidence is quite strong, but it is just short of being definitive where you would say, `thou shalt,"' he said. But, he added, "I think it is reasonable to say that it is the preferred option to get these people to an L.D.L. level of less than 70."
It will not be an easy goal to achieve, heart disease experts said.
Dr. Scott M. Grundy of the University of Texas Southwestern Medical School at Dallas, the lead author of the new report, said, "A standard dose of statins gets most people close to 100.
"If you are going to get from there down to 70, you have to take a high dose of statins," he said, "which still might not get you there."
One possibility, he said, is to add another drug like niacin or ezetimibe, a drug that reduces the amount of cholesterol absorbed from the digestive tract.
But even then, said Dr. Daniel Rader, director of preventive cardiology at the University of Pennsylvania School of Medicine, many people will not be able to reach an L.D.L. level of 70.
"There definitely are still going to be people who even with combination therapy can't get their L.D.L. level into that range."
No one doubts that the new recommendations will be expensive. But, said Dr. Cleeman, statins, which cost about $100 a month, are cost effective in those who should be taking them, because heart disease costs "hundreds of billions of dollars."
Statins, which can reduce the risk of heart disease by 30 to 40 percent, he said, "compare very favorably to other standard treatments, like treatments for hypertension."
The stock of Pfizer and Merck, two manufacturers of statin drugs, showed little change yesterday.