Expert view: New guidelines on cholesterol drugs are flawed

Some seemingly healthy men and women could benefit from taking a cholesterol-lowering statin, according to draft guidelines published Monday by the US Preventive Services Task Force, an independent panel of clinicians established by Congress to develop federal guidelines for tests and treatments aimed at preventing disease.

There’s little question that statins save lives when taken by individuals who have had a heart attack or stroke. Things are a bit murkier for adults without heart disease. The task force is now recommending a low- to moderate-intensity statin for 40- to 75-year-olds who might seem healthy but have a higher chance developing heart disease because of high blood pressure, high cholesterol, diabetes, or smoking.

For perspective on the draft guidelines, I talked with Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic.

The draft guidelines from the USPSTF look a lot like the guidelines published in 2013 from the American Heart Association and American College of Cardiology. Are they better?

Patients and providers, including me, were confused by the 2013 guidelines. Why the task force has come out with its own similar — but different — guidelines adds to the confusion. For example, the American Heart Association and American College of Cardiology guidelines recommend starting a statin when the 10-year risk is 7.5 percent. The task force says 10 percent. I don’t think it makes public health sense to have multiple guidelines that don’t completely agree with each other floating around.

These guidelines use cardiovascular risk to determine who should take a statin. Does that make sense?

Using cardiovascular risk to determine whether to take a statin is definitely reasonable. But if you are going to make a risk-based guideline, the way you calculate risk must be very, very good. I and others have criticized the risk calculator used by the American Heart Association and American College of Cardiology guidelines. It understates the risk in some populations, meaning some people who could truly benefit from a statin wouldn’t be advised to take one, and overstates the risk in others. I don’t understand why the US Preventive Services Task Force would recycle this flawed calculator.

What would make the calculator better?

One thing I must emphasize: Before this calculator was made public in the 2013 guidelines, it had never been published in a peer-reviewed paper. The first time many of us saw it was the day it appeared as part of the guidelines. This calculator needs to be verified in various populations, and adjusted to improve its accuracy. It also excludes family history, one of the most powerful risk factors for cardiovascular disease. Risk calculators that include this information, like the Reynolds Risk Score, do a better job of estimating an individual’s cardiovascular risk.

The USPSTF draft guidelines cover only individuals between the ages of 40 and 75. Does that mean older people shouldn’t take a statin?

Truncating treatment recommendations at age 75 is not sensible. In an important trial called IMPROVE-IT, published earlier this year in the New England Journal of Medicine, the researchers found something remarkable. People under age 75 who took a statin plus another cholesterol-lowering drug called ezetimibe [a Merck drug marketed as Zetia] got very little benefit from the medications, while those over 75 benefited, meaning they had lower rates of heart attack or stroke or needing artery-opening angioplasty or bypass surgery.

Statins aren’t risk-free. How do individuals and their doctors balance benefits and risks?

Side effects are always a concern. People at low risk for a heart attack or stroke shouldn’t be taking a statin because they get little or no benefit while shouldering the possibility of harm. These include muscle pain and a possible small rise in blood sugar. But keep in mind that these risks are small, especially for the low and moderate doses of statins the task force is recommending. In addition, if these problems appear, stopping the drug eliminates the problem. These factors make it easier to recommend statins to a wider group of individuals, especially since cardiovascular disease is the leading cause of death in the United States and many other countries.

If the guidelines are unclear, what’s the best way for individuals to answer the question, ‘Should I be taking a statin?’

Find a thoughtful doctor who is independent and who won’t just parrot back the guidelines. He or she should be willing to talk openly about statin use and the prevention of cardiovascular disease. Nothing beats a conversation like that. Patients have different value systems, preferences, concerns, and issues such as family history that aren’t in the guidelines. Including these in the process known as shared decision-making is very powerful.

If your doctor doesn’t really want to talk with you or share the decision making, find another doctor.