New statin guidelines stir controversy

Medical guidelines are meant to unify doctors and standardize care for patients around treatments supported by the best available science.

But the latest guidelines on the use of statins, a class of drugs used to reduce cholesterol, are already generating significant pushback from doctors. The controversy is likely to confuse patients.

The new rules released this week by the American Heart Association and the American College of Cardiology would expand the number of people getting statins to prevent heart disease, heart attacks, or stroke while eliminating specific numeric goals for LDL, or bad cholesterol.

Some critics say the new guidelines will have too many patients taking drugs while others worry that young people at high risk of heart disease are left out.

There's concern that easy access to pills will further work against efforts to get patients to live healthier lifestyles.

"I already think there are way more people on statins than are getting any benefit," said Rita Redberg, a cardiologist at University of California San Francisco Medical Center and editor of JAMA Internal Medicine. "These guidelines are exacerbating that."

While some agree there's not enough evidence to support specific LDL targets, others say that patients become more invested in care if they have a specific goal. The guidelines also mean there will be little reason to take a second or third cholesterol-lowering drug.

The National Lipid Association announced that it could not support the new guidelines, in part because of the LDL change. Previous guidelines called for patients to reach LDL goals of 70, 100, or 130, depending on their risk. "We question the need to remove such important and well-known clinical performance metrics that have been so widely endorsed by the clinical community," the group said.

Matthew Ito, an Oregon State University pharmacist who leads the organization, said the new guidelines are a "huge paradigm shift." They are based only on top-quality clinical trials (which, critics point out, were industry-funded.) Ito said that "other levels of clinical evidence" clearly support the idea that lower levels of cholesterol are better.

Mariell Jessup, a University of Pennsylvania cardiologist who is president of the American Heart Association, said the new guidelines assess individual patients' risk. "I think it's getting back to focusing on patients rather than a blood test or a biomarker," she said.

There was previous concern, she added, that people who were not really at high risk for strokes or heart attacks were on statins just because they had high LDL. Most statins are now low-priced generics. She said it's not clear whether the new rules will lead to more statin use. "I don't think it's easy to estimate who will be on them and who will not," she said.

Statins clearly lower cholesterol, she said, but they may also combat heart disease by reducing inflammation and healing blood vessels.

The new guidelines call for patients in any of four categories to take statins: people with a history of heart attack, stroke, angina, or peripheral artery disease; people 21 and older with LDL cholesterol at 190 or higher; people with diabetes who are 40 to 75 years old; and people 40 to 75 who do not have heart disease but have a risk of 7.5 percent or higher of having a heart attack or stroke within 10 years.

Daniel Edmundowicz, chief of cardiology at Temple University Hospital, said the changes will require a lot of education for doctors and patients. "The change in the message, though, is so great . . . that you always run the risk that the wrong message is going to be given," he said.

He is among those worried that patients at high risk for heart disease, perhaps because of a family history, will no longer be considered statin candidates. He said there will be a greater need to establish the presence of heart disease in such patients with CT scans or ultrasounds.

He also said the LDL goals were valuable motivators for patients.

Beatrice Golomb, a professor of medicine at the University of California San Diego who studies statins, said evidence supports using them in "middle-aged men that have clear clinical heart disease." She said there is not strong evidence for using statins in women and elderly people.

David Fischman, a cardiologist at Thomas Jefferson University Hospital, questions whether it's a good idea to give diabetics with a low LDL the drugs while not giving them to people with a family history.

He thinks patients can adjust to the idea that the goal is to reduce their cholesterol, not bring it to a certain level. After all, doctors are the ones who tell patients what the goals are.

The guidelines call for higher doses that could increase side effects, said David Becker, a cardiologist with Chestnut Hill Temple Cardiology. He thinks the guidelines tell at-risk patients that the answer is to take a drug. He prefers telling them that they should first work hard on lifestyle changes: stop smoking, lose weight, and exercise more.

John Abramson, a Massachusetts health policy expert, agrees with Becker that the new guidelines will distract people from changing the way they live, which causes 80 percent of heart disease risk. "It's just craziness," he said. "We ought to be focusing on how to help people successfully alter their lifestyles."

The American Heart Association and American College of Cardiology have issued the first new guidelines in a decade for preventing heart attacks and strokes. Among other things, they call for twice as many Americans - one-third of all adults - to

consider taking cholesterol-lowering statin drugs.

What's New

The guidelines take aim at strokes, not just heart attacks. They're personalized for men and women, and blacks and whites. They estimate a person's risk in a novel way and change the goal of treating high cholesterol.

Estimating Risk

A new formula includes age, sex, race, blood pressure, cholesterol, diabetes, and smoking. People ages 40 to 79 should get an estimate every four to six years. If risk is still unclear, family history or three other tests can be considered. The best

one is a coronary artery calcium test, an X-ray to measure calcium in heart arteries.

Cholesterol

High cholesterol leads to hardened arteries, which can cause a heart attack or stroke. Most cholesterol is made by the liver, so diet changes have a limited effect, and many people need medicines to lower their risk.

The guidelines don't change the definition of high cholesterol, but they say doctors should no longer aim for a specific number with whatever drugs can get a patient there. The new advice stresses statins such as Lipitor and Zocor; most are generic

and cost as little as a dime a day.

Who Needs Treatment?

Four groups are targeted:

People who already have heart disease (clogged arteries).

Those whose LDL, or "bad cholesterol," is 190 or higher, usually because of genetic risk.

People ages 40 to 75 with Type 2 diabetes.

People ages 40 to 75 who have an estimated 10-year risk of heart attack or stroke of 7.5 percent or higher, based on the new formula. (This means that for every 100 people with a similar risk profile, seven to eight would have a heart attack or a stroke within 10 years.)

The Bottom Line

About 33 million Americans - 44 percent of men and 22 percent of women - would have enough risk to consider a statin. Only 15 percent of adults do now.

The Role of Lifestyle

Guidelines also recommend 40 minutes of moderate to vigorous exercise three to four times a week. They call for a "dietary pattern" that is focused on vegetables, fruits and whole grains and includes low-fat dairy products, poultry, fish, beans and

healthy oils and nuts. Limit sweets, sweet drinks, red meat, saturated fat, and salt.

To fight obesity, doctors should develop individualized weight-loss plans including a moderately reduced-calorie diet, exercise and behavior strategies. The best plans offer two to three in-person meetings a month for at least six months. Web or phone-based programs are a less ideal option.    - Associated Press

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