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Is there a middle ground in the statin debate?

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The statin debate is getting uglier. In an editorial in the Annals of Internal Medicine, Dr. Steve Nissen of the Cleveland Clinic expressed his frustration with low statin adherence in patients who had an adverse reaction to the medication. Nissen partly blamed the low adherence rate on “statin denial,” what he calls an “internet-driven cult.”

Nissen’s main issue appears to be with the dietary supplement industry, which promotes unproven dietary supplements instead of statins for cholesterol management. But there are legitimate scientific arguments for caution against using statins, and in comparing statin skeptics to cultists, Nissen paints supplement peddlers and respected physicians all with the same broad brush.

Who should take statins?

The main question surrounding the statin debate is whether or not statins should be used for what is called “primary prevention” to prevent a cardiac event in patients who do not have heart disease but may be at risk. Updated guidelines by the American Heart Association and the American College of Cardiology in 2013 recommended that statins be given to patients with certain risk factors of heart disease or stroke, which would increase the number of Americans on statins by about 70%.

However, many doctors found this advice to be an overreach, given the small benefits of statins for patients without heart disease (absolute reduction in heart attacks of about 1% over five years and absolute mortality reduction of 0-0.4%, depending on the study1). Using an optimistic estimate, this means it would take 50 healthy people taking a statin every day for five years to prevent one heart attack, and 250 people to prevent one death.

What do we value?

Perhaps the question we should be asking is, “What do patients value?” As Dr. Michel Accad points out in a thoughtful blog post, the statin debate sometimes has more to do with values than data:

“Those in the pro statin camp value reducing the risk of a heart attack by a small percentage more than the price they are willing to pay: a larger risk of having side effects. And they hold that position not because there is a compelling mathematical reason to hold it. It’s not that 15 years of muscle pain equal one added life-year saved, or some explicit calculus of that nature. They hold that position as a preference.”

The statin debate sometimes has more to do with values than data.

Of course, patients have their own preferences and values, which often are not the same as those of their doctor. For some patients, the potential side effects and taking a pill every day may be a significant burden; others may want to do everything they can to avoid a heart attack or stroke. To paraphrase Dr. John Mandrola’s excellent commentary on this issue, treating 50 healthy people with a pill to prevent one heart attack makes sense when applied to large populations, but patients are individuals, not populations.

Where is the balance?

Clinicians like Dr. Mandrola are finding a middle ground in the statin war by acknowledging the benefits and risks to using statins for primary prevention and making sure that patients are involved in the decision rather than simply prescribing the medication.

For example, Dr. Andy Lazris, a primary care doctor and member of the Right Care Alliance, uses visual decision aids show patients the potential risk of both heart disease and side effects, with and without statins. “I make it clear to the patient that they do not have to go on statins, that it’s totally their choice,” says Lazris, “I just am here to tell them about the potential benefit.” (And potential harms.)

An example of the “theater” aids Dr. Lazris shows to patients to demonstrate the potential benefits of taking statins. From right to left, the shaded boxes are proportion of low-risk, medium-risk, and high-risk patients who will benefit from taking statins for five years.

An important part of the decision-making process is talking with patients about other ways they can improve their heart health, including a healthful diet, exercise, and quitting smoking. “Step one is to talk to patients about lifestyle modifications,” says Lazris, “In many cases, that’s better than statins at reducing the risks of heart attack and stroke.”

”How about treatment of people instead of treatment of cholesterol?”

Another doctor wrote to us on the topic:

“Historians will, I think, examine us with curiosity for focusing so much on statins. They will see more the shifts in money, the tremendous capitulation to markets, and a wincing obsession with a failed surrogate marker. How about treatment of people instead of treatment of cholesterol?”

 

 1. A 2016 JAMA study shows 0.81% reduction in absolute risk of heart attacks and 0.4% for mortality. In The BMJ John Abramson et al. (2013) find no effect on mortality from taking statins. David Newman’s analysis (2013) finds an absolute risk reduction of 1.6% for heart attacks and no effect on mortality.