Story highlights New guidelines could double the number of folks eligible for medication, experts say

These guidelines call for a focus on risk factors, not just cholesterol levels

The policy say it's important how patients lower "bad" cholesterol

If you're not on medicine to lower your cholesterol yet, you might be soon.

In what's being called a tectonic shift in the way doctors will treat high cholesterol, the American Heart Association and the American College of Cardiology on Tuesday released new treatment guidelines calling for a focus on risk factors rather than just cholesterol levels.

The new guidelines could double the amount of people on medication to lower their cholesterol, experts say.

"This is an enormous shift in policy as it relates to who should be treated for high levels of cholesterol," said Dr. Steven Nissen, chief of cardiovascular medicine at the Cleveland Clinic

The biggest change from the old guidelines, he says: Ignore the numbers.

"For many years, the goal was to get the 'bad' cholesterol levels -- or LDL levels -- below 100," Nissen said. "Those targets have been completely eliminated in the new guidelines, and the threshold for treatment has been eliminated."

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In their place, the guidelines suggest using specific risk factors to determine who should be treated with cholesterol-lowering statin drugs, and who should simply make lifestyle changes.

Among the four questions to ask to determine risks: Do you have heart disease? Do you have diabetes (Type 1 or 2)? Do you have a bad cholesterol level more than 190? And is your 10-year risk of a heart attack greater than 7.5%?

According to the new guidelines, if you answered yes to any of those four questions, you should be on a statin. Period.

For those who do not fit those criteria, the committee behind the new policy says lifestyle and behavior management should be sufficient to help manage high cholesterol.

"The focus for years has been on getting the LDL low," said Dr. Neil Stone, committee chairman.

"Our guidelines are not against that. We're simply saying how you get the LDL low is important. Considering all the possible treatments, we recommend a heart-healthy lifestyle and statin therapy for the best chance of reducing your risk of stroke or heart attack in the next 10 years."

Calculating risks

So how do you and your doctor determine if your 10-year risk of a heart attack is above 7.5% and you should be put on a statin?

A simple calculation, said Dr. Donald Lloyd-Jones, chairman of the committee that developed the equation.

"We were able to generate very robust risk equations for both non-Hispanic white men and women as well as African-American men and women," Lloyd-Jones said. "Those equations factor in age, sex, race, total and HDL ('good') cholesterol levels, blood pressure levels, blood pressure treatment status as well as diabetes and current smoking status."

Each of those factors is assigned a numerical value and can be used to determine individual risk percentage using an online calculator

The hope, Lloyd-Jones said, is that by doing these calculations, patients can be more informed about their risks when going to see doctors.

"The greatest strength behind these guidelines is that they hit at the heart of prevention -- which is that lifestyle, rather than treating isolated risk factors, is the key to reducing risk of chronic disease," said Dr. Sharon Horesh Bergquist, an assistant professor of medicine at Emory University, in an e-mail.

"We tend to focus on 'quick fix' answers such as a pill ... whereas the risk reduction from lifestyle changes, such (as) exercise three-four days a week, reduces risk nearly double to that from any one of the medication interventions."

Double the prescriptions

By changing the way doctors evaluate a patient for statin therapy, Nissen said these new guidelines will effectively double the number of Americans eligible for statin therapy, bringing the total to about 72 million.

So does this mean big bucks for the pharmaceutical companies? Nissen said no -- and in fact, it may mean a downturn in their business.

"Now, except for Crestor, they're virtually all generic -- you can get a three-month supply for $10," he said. "So there's really no money to be made with statins anymore."

He goes on to say that while prescriptions for these drugs will increase dramatically, the guidelines all but shunned other cholesterol-lowering drugs such as Zetia, a big moneymaker for Merck & Co.

Aside from the financial aspects of medicating 35 million more Americans, using statins in a much broader population has been controversial.

Some people, such as cancer expert Dr. David Agus, advocate giving everyone older than 45 a statin, due both to cholesterol-lowering properties and potential benefit in reducing cancer.

Others say that with the potential side effects from statin use -- muscle pains and soreness, a potential moderate increase in liver disease and a risk for developing Type 2 diabetes -- they should be used with care.

Nissen, who strongly disagrees with Agus' suggestion on statins, said a measured approach is best.

"If you have a young woman who is otherwise healthy, giving (her) a statin doesn't make any sense at all," Nissen said. "I do believe the evidence is solid that if you have risk, that statins are enormously beneficial."

Other recommendations

In addition to the guidelines on evaluating cholesterol risk, the American Heart Association and American College of Cardiology released two other sets of guidelines relating to overall heart health.

One report gives guidelines for eating a heart-healthy diet, including reducing saturated and trans fats as well as limiting sodium to 2,400 milligrams per day -- 30% less than the average American consumes on a daily basis.

The other report dealt with treatment guidelines for physicians on managing weight loss in their patients. They include a call to create individualized weight loss plans and recommend counseling with a dietitian or other certified weight loss professional for at least six months.

That report also goes on to suggest that doctors should begin offering bariatric surgery as a potentially viable option to improve health for patients with a body mass index over 40, or those with a BMI over 35 and other complicating factors.