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New Statin Guidelines Stir Controversy

This article appeared in Philly.com and was written by Stacy Burling. You can see more of Philly.com at http://www.philly.com

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.”
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