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New statin guidelines expand how doctors calculate which patients could benefit

November 13, 2013 at 12:00 AM EST
Leading heart organizations issued new recommendations for the way doctors prescribe cholesterol-lowering statin drugs. Hari Sreenivasan talks to Dr. Harlan Krumholz of Yale School of Medicine about how a new risk calculator could help doctors shift their focus from lab results to more holistic thinking about who might benefit.
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GWEN IFILL: Now, on another health-related matter: what people need to know about new guidelines concerning cholesterol-lowering drugs.

Hari Sreenivasan has the story.

HARI SREENIVASAN: The recommendations by the nation’s leading heart organizations are the first new cholesterol guidelines released since 2004.

For decades, doctors have prescribed cholesterol-lowering statins to their patients based on their laboratory numbers. But the new recommendations focus on risk factors, including whether individuals have diabetes or heart disease, or if they have a level of so-called bad cholesterol known as LDL. That’s 190 or higher.

Dr. Harlan Krumholz is a cardiologist and a professor of medicine at the Yale School of Medicine who has long studied this issue.

So, Dr. Krumholz, how significant are these new guidelines?

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DR. HARLAN KRUMHOLZ, Yale School of Medicine: Yes, these guidelines are profound. They’re a marked difference from the prior guidelines.

Again, the ones that we’re talking about are ones about decision about the use of medications. And we really have changed from a singular focus on targets, pushing people to get their cholesterol levels to a certain point, to thinking more holistically about the patients, their risks and what they stand to benefit from the use of drug therapy.

HARI SREENIVASAN: So, when it comes to LDL, is that a bad measure? Should we not be keeping that sort of in control?

HARLAN KRUMHOLZ: Well, people need to know a couple things.

First, I just want to say the guideline that is getting all the attention is the one about drugs. We remain steadfast in our advocacy for people to pursue healthy lifestyles. And we prefer not to use medications at all. We would like the population to lower their risk just by being healthier, by being more active, and achieving the right weights and not smoking.

But with regard to these drugs and thinking about cholesterol, the cholesterol hypothesis, the idea that cholesterol is important in heart disease remains. In cholesterol, the bad cholesterol and the good cholesterol turn out to be predictors of heart disease. But what we have recognized is that maybe we have been treating some of the wrong people, because, by a singular focus on your lab test, we have perhaps often been treating people with mild elevations of bad cholesterol who were otherwise at low risk and had relatively little to gain.

And there have been others with low cholesterol who could have benefited from some of these medications, but who we may have neglected, not recognizing that they had a lot to gain.

HARI SREENIVASAN: So, let’s talk a little bit about those recommendations. Who now qualifies under the new risk calculator?

HARLAN KRUMHOLZ: Well, so, the way that this works — and there is a calculation, but I think it’s good to think about this as a general principle.

The idea is trying to identify people who have a lot to gain, that is, those people for whom medications are likely to lower the risks substantially, so it’s worth taking a medicine every day, it’s worth exposing yourself to some of the adverse effects.

And what they did was, they said, look, if your cholesterol is markedly elevated, that should probably qualify you, because, by definition, you’re at high risk if your bad cholesterol, the LDL cholesterol, is markedly elevated.

For people with diabetes, although not everyone with diabetes is at high risk, in general, we tend to think about it as elevating your risk, and they said, we think that people with diabetes would be best served by also being on these drugs. And, by the way, on these drugs means statins.

I mean, another piece of this guideline was to de-emphasize the drugs that we have that lower LDL cholesterol, but are unknown with respect to their benefit, like ezetimibe, or Zetia, or some of the other drugs, the non-statin drugs.

So, they said, gee, if you have diabetes, that’s another group that might be more likely to benefit. And then, after that, they said, if you don’t have diabetes or markedly elevated cholesterol, let’s take a look at all of your risk factors and figure out if you’re in a range where it might be worth it for to you take a statin.

And then they — they have introduced a calculator that’s online that people can use. But the general principle is trying to figure out, am I someone who is likely to have a big benefit from taking these drugs? Because, if you’re not, and especially if the benefit’s really small, it may not be worth it to you.

HARI SREENIVASAN: So, how significant is that population size that may not be prescribed statins anymore, or the — I should say the additional medications?

HARLAN KRUMHOLZ: Well, there’s some — yes, yes.

I think there’s some controversy right now. My own view is that the guidelines are just guidelines. They’re — they’re helping us to think about what these experts when they sat in the room felt were the right thresholds for treatment, where my risk gets high enough to treat.

But the truth is, we should be personalizing those decisions. That takes place between a patient and their doctor. And each person may have a different perception on whether it’s worth it to be treated. My sense of what’s high-risk that would make it worth it for me to take a medication may be very different than yours.

For this guideline, they settled on a number. They said, if your risk over 10 years of heart attacks and strokes was 7.5 percent or greater, about one in 12, one in 13, they thought it was probably worth it for to you take a statin. And they recommended it.

My own view is, that depends. I mean, it depends on you, and it should be personalized. Now, I don’t know at the end of the day whether more people or fewer people are going to be taking statins, but I do know that we will be making wiser choices if we’re tailoring our treatments to what you stand to gain and if you’re making an informed choice based on whether it’s really worth it to you, whether you’re likely to benefit.

And that — that’s really where we’re turning, from a singular emphasis on the lab test to trying to look at you as a whole about whether or not you’re going to be able to avoid a heart attack or stroke. And how big is that the benefit for you? How likely is it that you’re going to be the one who is going to avoid that problem?

HARI SREENIVASAN: So, if we increase the pool of people that might qualify for statins, is there a chance that we will have increased numbers of adverse side effects?

HARLAN KRUMHOLZ: Well, these drugs are fairly safe.

Look, any drug we take has the potential for adverse effects, and statins, like all drugs, do have some rare adverse effects, and they have some others that — that may cause problems. We know that they can sometimes raise sugar levels, glucose levels.

But the trials are fairly unequivocal. These drugs, by and large, lower risk, and they lower risk by about 20 percent. They are tried and true. They’re among the best drugs that we have. That being said, for someone who has got little to gain, I don’t — I don’t think that they should take them.

These aren’t for everyone. I don’t think they should go in the water. And it really is a personal choice, whether you think the potential benefit is big enough. But, yes, you’re right. If we treat low-risk people — and in the past, I think we have done that more just by focusing on the lab tests — those people may have more harm than good. And that’s why we have to focus on those most likely to benefit.

HARI SREENIVASAN: All right, Harlan Krumholz, thanks so much for your time.

HARLAN KRUMHOLZ: Thank you.