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New clinical practice guidelines for cholesterol management suggest more intensive treatment options for those at high or moderately high risk of heart attack or other major cardiac events, including patients with diabetes.
The guidelines suggest initiating statin therapy earlier and at lower thresholds, and encouraging patients to assume healthier lifestyle changes.
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Issued by the National Cholesterol Education Program (NCEP), which is coordinated by the National Heart, Lung, and Blood Institute (NHLBI), the recommendations are based on five large-scale clinical trials examining the impact of statin therapy to reduce low-density lipoprotein (LDL) cholesterol, especially among high-risk patients.
All of the trials were conducted after the release of NCEP's last cholesterol guidelines, the Adult Treatment Panel (ATP) III Report, in 2001. The new guidelines, published in the July 13 issue of Circulation, are based on information learned since then.
The guidelines suggest the following LDL-lowering therapies by levels of risk:
"If you look at the [published] abstract, there are 23 lines, and the word `risk' is mentioned 17 times," says Stone, a cardiologist, lipidologist, and professor of cardiology at Northwestern University's Feinberg School of Medicine in Chicago. "These recommendations for cholesterol management are based on risk."
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PATIENTS AT RISK
Stone says he has found some confusion among providers about the update, particularly among those who have only paid attention to the headlines and not read the guidelines themselves.
"[They are] very concerned that we are treating everybody more aggressively, when in fact that isn't what the guidelines say," Stone says. The newer, more intensive goals for those at very high risk or moderately high risk are "optional and require physician judgment," he says. "This requires a physician assessing the patient's risk and determining—based on that risk—what strategies would benefit them the most."
Others may differ on the exact goals, but do agree that high-risk individuals need to be treated more intensively. "Most agree with the fact that you use statins to achieve a 30%–40% reduction in LDL cholesterol, and that high-risk people need to be treated intensively," says Stone.
Very high-risk patients, according to the NCEP, are those who have cardiovascular disease plus multiple risk factors, especially diabetes; or severe and poorly controlled risk factors such as smoking; or metabolic syndrome, a constellation of risks associated with obesity such as high triglycerides and low high-density lipoprotein. Patients who are hospitalized for acute cardiac events—such as heart attack—also are at very high risk.
Individuals at high risk include those who have coronary artery disease or noncoronary forms of clinical atherosclerotic disease, diabetes, or multiple risk factors that give them a greater than 20% chance of having a heart attack within 10 years.
Moderately high-risk patients are those who have multiple coronary heart disease risk factors, along with a 10%–20% risk for a heart attack within 10 years.
MAKING AN IMPACT?
With more potent statins, it's becoming easier to lower LDL cholesterol quickly, says Martin Abrahamson, MD, acting chief medical officer at the Joslin Diabetes Center in Boston. "I think what we need to do is get people to treat lipids earlier."
"If you can use drugs that are safe and effective and not associated with other new complications, then why shouldn't you use those drugs?" he says. "Why should you wait for an LDL to be above 100 mg/dl if you believe it should be below 70 mg/dl?"
Getting patients on board with a new drug therapy and lifestyle regime will take some effort by physicians and other providers, says Wm. James Howard, MD, an endocrinologist specializing in lipid disorders and vice president of academic affairs at the Washington (D.C.) Hospital Center.
"[Physicians] have to be able to take the time to talk with patients about it—to present the risk and tell them why everything they're doing is beneficial, even though it seems to limit their opportunities in terms of lifestyle—making it a little more rigid," says Howard, who was on the 2001 ATP III panel. "But in the long run, it's opening up things to them because they are not going to have to deal with heart attacks and catheterizations."
But a successful course of treatment using statins and a therapeutic lifestyle means relying not only on physicians but on a clinical team to make sure patients are complying. "There need to be people in the office who can take a little more time" to counsel patients, he says. Oftentimes, patients will think that once they meet the desired goal for cholesterol, they no longer have to take medications.
Providers should ask patients if they are still taking medications and when they are taking them, since some statins need to be taken at bedtime. Also, diet and exercise habits should be reviewed. "You can do that almost like a check-off list," says Howard. "You need to organize your time well to get to the essentials."
UPDATE CONTROVERSY
The update, after it was released, had an additional spotlight placed on it because eight of the authors had financial ties to the pharmaceutical industry, such as speaking honoraria and research grants.
"You have physicians who received financial payment from companies that have conducted the studies [on statins]," says Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest in Washington.
"It seems the NHLBI has violated a principle that ought to be enshrined at the National Institutes of Health—not violated," says Goozner, author of a new book, The $800 Million Pill: The Truth Behind the Cost of New Drugs. "That principle is that you get independent reviewers to review the published literature when you provide the public with updates on clinical guidelines."
Many of the initial trials to determine if statin drugs could be valuable in controlling lipids were financed by the pharmaceutical companies, Stone says. However, the companies had no control over the outcomes. "They were done with a double-blind, randomized, placebo-controlled design," Stone says.
"There is indeed no recommendation for any one drug in any of these recommendations," Stone adds. "Three of the large-scale clinical trials of statin therapy in those with coronary heart disease or patients greatly at its risk showed a reduction in total mortality. The other trials that used statin therapy to achieve at least a 30% decline in mortality showed a reduction in fatal heart attacks and coronary events. Certainly, if you live longer, it's hard to read into that anything other than that you're doing better.
"And in that sense, the ability for physicians to have guidelines to
know how to target their use and how to use them safely—I think that's a
great advantage," Stone adds. 
Footnotes
FYI The complete NCEP cholesterol uidelines are available at www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04.pdf.
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