Features June 2014 Issue

New Cholesterol Guidelines May Increase Statin Use

A broader assessment of cardiovascular risk could bring vast increase in statin use.

It’s been more than 36 years since the first cholesterol-lowering statin drug was introduced. And just as the family of statin medications has grown over time, now the number of people who will be prescribed the drugs may also increase.

New guidelines boost the percentage of people eligible for statins.

New cholesterol guidelines released in November 2013 by the American Heart Association (AHA) and the American College of Cardiology (ACC) shifted the focus from treating specific cholesterol levels to a broad assessment of an individual’s risk of having a heart attack or stroke. These new guidelines could result in nearly 13 million more adults being put on statins, according to an analysis published in the New England Journal of Medicine (NEJM).

The study showed that among adults age 60 to 75, the number of men eligible for statins would increase from 30 percent to 87 percent; and from 21 percent to 54 percent among women.

Key changes to the guidelines
There are three major features of the new guidelines: focus on therapies proven effective in randomized clinical trials, and therefore emphasis on statin therapy; a new risk calculator for treatment decisions in individuals without cardiovascular disease or diabetes; and elimination of cholesterol goals for therapy. Some of these changes are useful, but others may not be, according to Michael Rocco, MD, Medical Director of Cardiac Rehabilitation and Stress Testing and staff cardiologist at Cleveland Clinic.
According to the guidelines, those who are at high risk and are appropriate candidates for high or moderate intensity statin therapy include anyone who has cardiovascular disease, elevated LDL cholesterol above 190 mg/dL; diabetes between the ages of 40 and 75; and anyone without one of these criteria, but with a greater than 7.5 percent chance of having a heart attack, stroke or developing heart disease in the next 10 years based on the new risk calculator.

“The main premise of the new guidelines is to identify high-risk patients and treat them with statins at moderate to high dose level, since this therapy has proven beneficial in reducing adverse events in these populations,” says Dr. Rocco. “This is only a starting point and recommendation, but we should continue to tailor treatment to each patient’s needs.”

Obvious oversight?
While the number of those who are now eligible for statins under the new guidelines may greatly increase, based on the NEJM analysis, some experts contend that a group of high-risk patients may actually be overlooked. By implementing the new risk calculator, which sets thresholds for risk for initiation of therpay, we may ignore patients in their 40s and 50s who are susceptible to cardiovascular disease, explains Dr. Rocco.

“The 13 million more Americans candidates for moderate intensity statin therapy are skewed to the elderly population, a group potentially at higher risk for side effects,” he says. “However, while expanding treatment in some groups, we may actually delay or not recommend treatment in higher-risk patients who are younger.”

The calculator doesn’t take into account family history of heart disease or inflammatory markers.

“Someone with an LDL in the 170 to 180 mg/dL range, but is younger and doesn’t fall into the first three categories, and has a risk score of less than 7.5 percent, would fall out of the typical recommendations for treatment,” says Dr. Rocco. “Yet, a decade later he may fall into the category for treatment and miss out on the lifelong benefit of starting statins earlier.”

It’s not about the numbers
A key piece of the new guidelines is to dismiss the longtime-honored method of achieving target cholesterol levels. Instead, the guidelines recognize that for those who have exhausted lifestyle changes and are considering drug therapy, it’s better to treat with proven doses and eliminate treatment goals.

“I’m not convinced that eliminating targets for therapy is a good thing,” Dr. Rocco says.

“From a patient and physician standpoint, having goals for therapy helps with drug compliance and adherence. It’s a tangible goal that you lose if a patient isn’t worried about targeting a certain number.

“The guidelines also tend to ignore the body of observational and clinical trial data supporting that lower LDL levels are associated with a greater reduction in the risk of cardiovascular disease,” he says. “This strategy fails to consider the potential benefit of treating to lower LDL-C or non-HDL-C goals in high-risk patients already on maximal tolerated statin doses and curtails consideration of combination drug therapy.”

Primary point
As the risk calculator’s effectiveness and the value of monitoring LDL levels continue to be questioned, the main point that can’t be overlooked is that statins are the prime therapy for lowering cholesterol and reducing the risk of cardiovascular disease, according to Dr. Rocco.

“Based on controlled clinical trials, statins are associated with substantial reduction in cardiovascular events, and higher intensity therapy has an incremental benefit. We need to identify patients that will most benefit and put them at appropriate levels of the medication,” he says. “Even if a patient isn’t eligible for treatment under the new guidelines, we may still need to consider statins based on individual need.”

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