What You Need to Know About New Heart-Care Guidelines

What You Need to Know About New Heart-Care Guidelines

Some Answers to New Clinical Recommendations

RON WINSLOW

Nov. 13, 2013 9:20 a.m. ET

For nearly a decade, the mantra for targeting LDL, or bad cholesterol, to reduce the risk of heart attacks and strokes was “the lower the better.” Now, new guidelines issued Tuesdayby two leading cardiology groups back away from that idea and scrap the long-standing goal of getting LDL to below 100—or below 70 for people at especially high risk. The new tack recommended by the American Heart Association and the American College of Cardiology is to prescribe moderate to high doses of cholesterol-lowering drugs called statins to patients who fall into one of four risk groups regardless of their LDL status. Here is a look at the implications:Q. Why get rid of the LDL targets?

A. The targets lack strong scientific evidence. The expert panel that developed the guidelines concluded that by focusing on an individual patient’s overall risk rather than a relatively arbitrary set of LDL targets, the strategy to prevent heart attacks and strokes will be more effective and more personally tailored to the needs and preferences of each patient.

Q. What should patients do in response?

A. Patients already on cholesterol-lowering medication should ask their doctors at their next appointment whether they are on the most appropriate therapy to reduce their heart-attack and stroke risk, says Neil Stone, a cardiologist at Northwestern University who headed the panel that wrote the cholesterol guideline.

For people not on cholesterol drugs, a new risk calculator is available online. If you have a 7.5% chance of having a heart attack over the next 10 years, you are a candidate for treatment with a statin no matter your LDL level under the new guidelines.

Q. I have no heart problems and my LDL was 90 in a recent cholesterol test. Is it possible I should be on a statin anyway?

A. This could be a big area of confusion, cardiologists say. Age is a big driver of the risk score, says Roger Blumenthal, director of heart-disease prevention at Johns Hopkins Medical Institutions, Baltimore. “A lot of people 55-plus are going to cross the 7.5% threshold not because they have bad [cholesterol] but because of their age and because their blood pressure is a little bit above 140,” he says. “Even though they were optimal last week, now we say you’re going to be treated” under the new guidelines. That’s a big change, and a lot of patients will balk at that.”

Q. What’s the remedy?

A. “This part of the guidelines needs to be taken as a recommendation not as a dictum,” says Harlan Krumholz, a cardiologist at Yale University. Patients need to discuss the benefits and risks of statins and the risk thresholds with their doctors. “Whether it’s worth it to you take a drug or not is a very personal decision.”

Q. What if I’m still on the fence after such a discussion?

A. The guidelines say answers to four other questions could help “break the tie.” Do you have a family history of early heart disease—a father or brother who had a heart attack by age 55 or a mother or sister by age 65? That would suggest you are also at risk. A high coronary-calcium score (over 300) as measured by a CT scan might push you to take a statin, doctors say, while a low one could provide reassurance that your arteries are healthy without medication.

Similarly, a score over 2 on a high-sensitivity test for a marker of inflammation called C-reactive protein would argue for treatment, while a low score would suggest you could forgo a statin. Finally, a high ankle-brachial index, a blood-pressure measurement, would indicate higher risk of a heart attack or stroke.

Q. What if I can’t take a statin?

A. Side effects of statins include muscle pain, muscle weakness and an increased risk of diabetes. Some people have reported cognitive deficits. And some either can’t tolerate high doses of the medicines or any dose at all. Donald Lloyd-Jones, head of preventive medicine at Northwestern, said the expert panel’s analysis of statin studies concluded that for most people they are safe. The recommendations say patients who need to can consider nonstatin cholesterol-lowering drugs—such as Merck MRK +1.01% & Co.’s Zetia—but only if they can’t tolerate statins at doses necessary to satisfy prevention guidelines. Lowering LDL with nonstatin medicines hasn’t yet been shown to reduce risk of bad events.

Q. What about lifestyle?

A. The guidelines say healthy diet and exercise habits and refraining from smoking are a fundamental part of heart-attack and stroke prevention whether you are also on statin therapy or not.

Q. I read that the new guidelines could double the number of people who qualify for statins. Did the drug industry help write the guidelines?

A. Many of the randomized studies that underpin the guidelines were sponsored by statin makers; most statins are now available in cheap generic versions. Dr. Lloyd-Jones said few members of the expert panel now have industry ties and that the panel took special care to avoid conflicts of interest in its deliberations. “People should have a lot of confidence that we didn’t have Big Pharma in the room with us making these decisions,” he said.

 

Panel Unveils Shake-up in Strategy to Cut Heart Risk

Long-standing strategy jettisoned under new guidelines

RON WINSLOW

Updated Nov. 12, 2013 7:48 p.m. ET

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.

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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 +0.60% PLC’s Crestor, the one remaining branded statin and the most powerful on the market, could get a boost from the recommendations. MerckMRK +1.01% & 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.”