New Cholesterol Guidelines for High-Risk Patients

New guidelines issued in 2004 call for significantly reducing LDL cholesterol levels in very high risk patients, following a trend that essentially says "less cholesterol is better" to reduce risk for cardiovascular disease and heart attack.

The new guidelines make it likely that several million more patients in the US will be prescribed cholesterol-lowering statin drugs, given higher doses of statins if they are already taking them, and/or given combinations of statins with drugs that block cholesterol's uptake in the body.

"This is a revision of our understanding of the pivotal nature of lipids and coronary artery disease," said David Marks, MD, Medical College of Wisconsin Associate Professor of Cardiovascular Medicine and Director of the Cardiac Catheterization Laboratory. "The research has continued to evolve and demonstrate that, particularly in the higher risk patients, the lower the LDL cholesterol, the better outcomes we're going to have for our patients.

"Those outcomes in particular are fewer heart attacks and fewer admissions to the hospital for events such as unstable episodes of chest pain. It is frequently difficult for many of our patients with high cholesterol states to actually achieve that without high doses of a single medicine and sometimes multiple medicines to control their cholesterol."

The goal levels, created by the National Cholesterol Education Program, vary by individual risk category. "Very high risk" patients, those who have recently had a heart attack or those who already have cardiovascular disease plus other multiple risk factors including smoking, high blood pressure or diabetes, should reduce their "bad" cholesterol (LDL) level to 70, down from 100 under the old guidelines.

A Standard of Care
Drug therapy is recommended under the new guidelines for nearly all "high risk" patients with LDL levels higher than 100. Those at "moderately high risk" (estimated to have a 10-20% chance of heart attack or cardiac death within 10 years) need treatment if LDL levels are 130 or higher and drug therapy should be considered as an option for them if the levels fall between 100 and 129.

The guidelines did not change for those in the "moderate" to "low" risk categories, who should keep their LDL levels at 130 or lower and 160 or lower, respectively.

"It has become somewhat analogous to treating high blood pressure, in that we have really set up a standard of care by which we initiate one agent, maximize the dose, and if we haven't hit guidelines add a second agent, maximize that dose," said Dr. Marks. "Then a third agent or a fourth agent; we continue adding agents and therapy until we reach guidelines.

"We're starting to really have to do that with cholesterol again. Patients get started on medicines for their cholesterol, we follow them up, we maximize the dose if needed, we add a second agent, we do lifestyle changes. For years we've appreciated the sequelae (effects and results) of high blood pressure. Now we're really recognizing the sequelae of even moderate levels of cholesterol and we're aggressively going after the therapy of that state."

Endorsers of the new guidelines include the National Heart, Lung and Blood Institute, the American College of Cardiology and the American Heart Association. The recommended goal levels were developed after review of five major studies involving cholesterol-lowering drugs.

Goals Achievable for Most Patients
Setting new goals for cholesterol levels doesn't mean that more people are at risk for heart attack than was previously thought, said Dr. Marks, but it does indicate that more people already at risk can benefit from cholesterol lowering. According Dr. Scott Gundy, the lead author of the guidelines, as many as 36 million people in the US could benefit from drugs to lower cholesterol (per 2001 data) and the new guidelines could add "a few million" more to that number.

Dr. Marks said that he believes the new guidelines are generally achievable. "We have potent medicines and we have multiple medicines," he said. "Not all the medicines are without side effects, and so we monitor patients quite closely. But, with a combined approach of multiple medications, dietary changes, weight reduction and exercise, we find that, yes, most patients ought to be able to meet these guidelines."

"In industrialized nations, we know that cardiovascular diseases are the number one cause of morbidity and mortality. It causes the most deaths. It causes the most health damage. So we know the risk is out there. We've identified blood lipids as a significant risk factor, and what we've continued to see is a reduction of the risk as we lower the cholesterol levels.

Changes to cholesterol level goals across all risk levels will no doubt continue to be made, said Dr. Marks. "Where we will likely see revisions of the data is we will continue to refine what the optimal level of cholesterol is with the risk and balance that against the side effects of the medication," he said. "We do know that if your cholesterol is zero, you won't live forever. So at some point the benefit curve flattens out. At some point there's no additional benefit to lowering your cholesterol any more.

"We're continuing to explore that curve, though, for all of our patients, and that's where the new research is going to take us. Similarly, we are early in our research in regards to HDL, the 'good' cholesterol, and other cholesterol sub-fractions such as certain lipoproteins."

Dan Ullrich
HealthLink Contributing Writer

MCW Health News presents up-to-date information on patient care and medical research by the physicians of the Medical College of Wisconsin.