Panel Unveils Shake-up in Strategy to Cut Heart Risk
Long-standing strategy jettisoned under new guidelines
By Ron Winslow
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The current strategy of reducing a person's heart-attack risk by lowering cholesterol to specific targets is being jettisoned under new clinical guidelines unveiled Tuesday that mark the biggest shift in cardiovascular-disease prevention in nearly three decades.
The change could more than double the number of Americans who qualify for treatment with the cholesterol-cutting drugs known as statins.
The guidelines recommend abandoning the familiar and easy-to-understand guidance to keep LDL, or bad cholesterol, below 100 or below 70 for people at high risk—a mainstay of current prevention policy. Instead, doctors are being urged to assess a patient's risk more broadly and prescribe statins to those falling into one of four risk categories.
The aim is to more effectively direct statin treatment to patients with the most to gain, and move away from relatively arbitrary treatment targets that are less reliable in predicting risk of attack than is widely believed.
"We're trying to focus the most appropriate therapy to prevent heart attack and stroke...in a wide range of patients," said Neil J. Stone, professor of medicine at Northwestern University Feinberg School of Medicine and head of the panel that wrote the guidelines.
Cardiovascular disease is the Western world's leading killer. In the U.S., it accounts for about 600,000 deaths each year, or about one in four. About 130,000 Americans die annually of stroke.
Numerous studies show that statins reduce the risk of heart attack and stroke. But solid data demonstrating the benefit of reaching specific targets are lacking, said Dr. Stone.
While lowering the LDL number remains a critical goal, the focus is on the risk reduction achieved with statins rather than the effect on LDL, said Donald Lloyd-Jones, chief of preventive medicine at Northwestern and a member of the guidelines panel.
Cardiologists expect the recommendations, jointly developed by the American College of Cardiology and the American Heart Association, to substantially change the conversation between doctors and millions of patients over the best way to lower their risk of heart attack or stroke.
The risk groups identified in the guidelines include patients who have already had a heart attack, stroke or major symptoms of cardiovascular disease; those with an LDL of 190 or higher, which typically has a genetic cause; people with diabetes; and anyone ages 40 to 79 who faces a 7.5% risk of having a heart attack over the next 10 years, according to a new risk score. That score—with a lower threshold than under current guidelines—takes into account cholesterol level, smoking status, blood pressure and other factors.
All are recommended to take high or moderate statin doses that would result in LDL reductions of about 30% to more than 50%. If fully implemented, the guidelines could more than double the number of people who qualify for statins, to more than 30 million, the authors said.
The new approach is likely to have a modest immediate effect on the pharmaceutical industry. All but one of the statins available, including Lipitor, have lost patent protection and are available as inexpensive generics.
AstraZeneca AZN.LN +0.59% PLC's Crestor, the one remaining branded statin and the most powerful on the market, could get a boost from the recommendations. MerckMRK +0.52% & Co.'s Zetia, a non-statin cholesterol-reducer that is also an ingredient in Vytorin, could take a hit because the guidelines discourage use of agents that haven't been proven to reduce risk of bad events, unless patients can't tolerate the recommended level of statin treatment. Zetia hasn't been shown to reduce bad events even though it lowers LDL.
But both supporters and critics of the guidelines worry they will confuse patients and physicians, and disrupt an easy-to-understand and successful strategy. While statins haven't been the only factor, research shows there has been a significant reduction in heart attacks and death from cardiovascular disease in the past two decades since the drugs were introduced.
Having targets for LDL "gives doctors and patients something to shoot for" as well as a motivation to try to get there, said Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. "The elimination of target levels is going to be a huge change for physicians and patients," he said.
The authors of the guidelines say a change was needed because the numerical targets are too blunt a tool. The targets have never been tested in a clinical trial, but a review of the evidence suggested they could lead to undertreatment of some patients and overtreatment of others, doctors said.
For instance, a high-risk patient with an LDL of 180 who reduces it with a statin to 90 will substantially reduce his risk. Yet under current guidelines he may be viewed as failing therapy by not getting to 70. Doctors often prescribe additional, non-statin cholesterol agents for patients not reaching targets with a statin alone, but there is no evidence getting another 20 points lower would bring a further meaningful reduction in risk.
Similarly, said Dr. Lloyd-Jones, an older patient who had accumulated other risk factors but had an LDL of 99 might be missed under the current strategy, even though statins could offer significant benefit.
Statins "seem to work no matter what your lipids are," said Harlan Krumholz, a Yale University cardiologist, using a term referring to blood fats including cholesterol. He wasn't an author of the guidelines, but he has argued for moving away from LDL targets as a cornerstone of prevention. "Knowing your number can be useful in understanding your risk, but not in chasing it as a strategy to improve your outcome," he said.
Targeting LDL has been a strategy since the National Cholesterol Education Program was established to promote heart health in 1985. It became a dominant approach in the mid-1990s, after research demonstrated the ability of statins not only to lower LDL but to prevent heart attacks and death. As research linked higher doses of statins with further reductions in heart attacks, lower is better became the mantra for LDL.
Now, even without the emphasis on hitting LDL targets, the guidelines are expected to significantly boost statin use, in part because they add stroke reduction as a goal and thus include more women and minorities, who are more prone to strokes than heart attacks.
The researchers identified the 7.5% risk threshold as the point where the benefits of statin therapy to prevent first heart attacks or strokes clearly outweighed the risks, including muscle pain and a small risk of diabetes.
The cholesterol guideline was issued with three other heart-related recommendations to guide doctors on assessing risk, treating obesity and encouraging healthy diet and exercise habits.
The cholesterol document in particular is expected to generate controversy and will be discussed at a major session next week at the American Heart Association scientific meeting in Dallas.
"There will be a lot of controversy," said Dr. Stone, of Northwestern University. "You can't go anywhere new without creating a lot of questions. The hope is that we can answer those questions in a way that provides better patient care."
Write to Ron Winslow at ron.winslow@wsj.com
New guidelines urge wider use of cholesterol-lowering drugs to reduce heart attacks, strokes
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The American Heart Association and American College of Cardiology released new guidelines to prevent heart attacks and strokes, focusing on cholesterol-lowering statin drugs.
The nation’s first new guidelines in a decade for preventing heart attacks and strokes call for twice as many Americans — one-third of all adults — to consider taking cholesterol-lowering statin drugs.
The guidelines, issued Tuesday by the American Heart Association and American College of Cardiology, are a big change. They offer doctors a new formula for estimating a patient’s risk that includes many factors besides a high cholesterol level, the main focus now. The formula includes age, gender, race and factors such as whether someone smokes.
The guidelines for the first time take aim at strokes, not just heart attacks. Partly because of that, they set a lower threshold for using medicines to reduce risk.
The definition of high cholesterol isn’t changing, but the treatment goal is. Instead of aiming for a specific number, using whatever drugs get a patient there, the advice stresses statins such as Lipitor and Zocor and identifies four groups of people they help the most.
“The emphasis is to try to treat more appropriately,” said Dr. Neil Stone, the Northwestern University doctor who headed the cholesterol guideline panel. “We’re going to give statins to those who are the most likely to benefit.”
Doctors say the new approach will limit how many people with low heart risks are put on statins simply because of a cholesterol number. Yet under the new advice, 33 million Americans — 44 percent of men and 22 percent of women — would meet the threshold to consider taking a statin. Under the current guidelines, statins are recommended for only about 15 percent of adults.
Some doctors not involved in writing the guidance worry that it will be tough to understand.
“It will be controversial, there’s no question about it. For as long as I remember, we’ve told physicians and patients we should treat their cholesterol to certain goal levels,” said the Cleveland Clinic’s Dr. Steven Nissen. “There is concern that there will be a lot of confusion about what to do.”
The government’s National Heart, Lung and Blood Institute appointed expert panels to write the new guidelines in 2008, but in June said it would leave drafting them to the Heart Association and College of Cardiology. New guidelines on lifestyle and obesity also came out Tuesday, and ones on blood pressure are coming soon.
Roughly half the cholesterol panel members have financial ties to makers of heart drugs, but panel leaders said no one with industry connections could vote on the recommendations.
“It is practically impossible to find a large group of outside experts in the field who have no relationships to industry,” said Dr. George Mensah of the heart institute. He called the guidelines “a very important step forward” based on solid evidence, and said the public should trust them.
Heart disease is the leading cause of death worldwide. High cholesterol leads to hardened arteries that can cause a heart attack or stroke. Most cholesterol is made by the liver, so diet changes have a limited effect on it.
Millions of Americans take statins, which reduce cholesterol dramatically and have other effects that more broadly lower the chances of heart trouble.
The patents on Lipitor, Zocor and other statins have expired, and they are widely available in generic versions for as little as a dime a day. One that is still under patent protection is AstraZeneca’s Crestor, which had sales of $8.3 billion in 2012.
Despite a small increased risk of muscle problems and accelerating diabetes in patients already at risk for it, statins are “remarkably safe drugs” whose benefits outweigh their risks, said Dr. Donald Lloyd-Jones, preventive-medicine chief at Northwestern.
Current guidelines say total cholesterol should be under 200, and LDL, or “bad cholesterol,” under l00. Other drugs such as niacin and fibrates are sometimes added to statins to try to reach those goals, but studies show they don’t always lower the chances of heart problems.
“Chasing numbers can lead us to using drugs that haven’t been proven to help patients. You can make someone’s lab test look better without making them better,” said Yale University cardiologist Dr. Harlan Krumholz, who has long urged the broader risk approach the new guidelines take.
They say statins do the most good for:
—People who already have heart disease.
—Those with LDL of 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 disease of 7.5 percent or higher, based on the new formula. (This means that for every 100 people with a similar risk profile, seven or eight would have a heart attack or stroke within 10 years.)
Aspirin — widely used to lower the risk of strokes and heart attacks — is not addressed in the guidelines. And many drugs other than statins are still recommended for certain people, such as those with high triglycerides.
Patients should not stop taking any heart drug without first checking with their doctor.
The guidelines also say:
—Adults 40 to 79 should get an estimate every four to six years of their chances of suffering a heart attack or stroke over the next decade using the new formula. It includes age, sex, race, cholesterol, blood pressure, diabetes and smoking. If risk remains unclear, doctors can consider family history or three other tests. The best one is a coronary artery calcium test, an X-ray to measure calcium in heart arteries.
—For those 20 to 59, an estimate of their lifetime risk of a heart attack or stroke can be considered using traditional factors like cholesterol and blood pressure to persuade them to change their lifestyle.
—To fight obesity, doctors should develop individualized weight loss plans including a moderately reduced calorie diet, exercise and behavior strategies. The best ones offer two or three in-person meetings a month for at least six months. Web or phone-based programs are a less-ideal option.
—Everyone should get at least 40 minutes of moderate to vigorous exercise three or four times a week.
—People should eat a “dietary pattern” focused on vegetables, fruits and whole grains. Include low-fat dairy products, poultry, fish, beans and healthy oils and nuts. Limit sweets, sweet drinks, red meat, saturated fat and salt.
“I don’t like the concept of ‘good foods’ and ‘bad foods,’” said Dr. Robert Eckel, a University of Colorado cardiologist who worked on the guidelines. “We really want to emphasize dietary patterns.”
Online:
Risk formula: http://my.americanheart.org/cvriskcalculator
Guidelines on cholesterol: http://bit.ly/1j2hDpH
Lifestyle: http://bit.ly/16ZnV7e
Overweight: http://bit.ly/1bsdFG2
Risk Assessment: http://bit.ly/19hzaV9
Cholesterol info: http://tinyurl.com/2dtc5vy
Heart facts: http://circ.ahajournals.org/content/127/1/e6
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Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP
Copyright 2013 The Associated Press. All rights reserved.
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