Research shows that statins are appropriate for millions more Americans

If 10 million more U.S. adults were on statin therapy, an estimated 41,000 to 63,000 cardiovascular events could be prevented over the next 10 years, according to new articles published in JAMA. This information could be particularly helpful to health care providers in deciding whether to prescribe a statin for patients with intermediate risk.

These studies were undertaken to gauge the applicability and cost-effectiveness of the 2013 American Heart Association (AHA) and the American College of Cardiology (ACC) cholesterol treatment guidelines. These guidelines recommend that statins be prescribed for people with a 7.5% or greater risk of heart attack or stroke over a 10-year period, including many with no existing cardiovascular issues. Previous guidelines (ATP III) had advised statin use only if the risk was 10% to 20% or higher.

But the 2013 guidelines have also stirred controversy. Critics argued that the cardiovascular risks were overestimated, that healthy adults would be overtreated, and that more people would be at increased risk for negative side effects, such as memory loss, type 2 diabetes, and myalgia. Proponents pointed to strong evidence that expanding statin use would reduce risk of heart attack and stroke.

The articles in JAMA found that the risk threshold specified by the 2013 AHA/ACC guidelines is likely to be reasonable and cost-effective. “There is no longer any question as to whether to offer treatment with statins for patients for primary prevention,” an editorial in JAMA stated.

Indeed, the guidelines may not even go far enough, the editorial said. While the ≥7.5% risk threshold was determined to be cost-effective, the researchers noted that an even lower threshold ≥3.0% would be optimal and would avert an estimated additional 160,000 cardiovascular disease events.

These findings offer particular guidance for patients at intermediate risk—“the most challenging group in clinical practice for whom to decide to initiate statin therapy,” the eligibility study authors wrote. They found that CVD events had occurred more frequently in people who would have been eligible for statin treatment under the ACC/AHA guidelines. Specifically, 6.3% of patients who would have been eligible for statin treatment had CVD events, compared with 1% of patients who would not be eligible.

In addition, the cost-effectiveness of statin therapy has lowered the risk threshold for people eligible for treatment, said Thomas A. Gaziano, MD, MSc, chief of the Division of Aging at Brigham and Women's Hospital in Boston and one of the study’s authors, in a JAMAinterview.

“Statins have gone from costing from between $1,000 to $2,000 per year—when they first came out and were patent protected—to less than $100 per year in the generic formulation,” he said. “Assuming generic statin prices only, we projected that it would be cost-effective to treat up to 61% to 67% of adults with statins.”

As of 2012, 26% of all U.S. adults over age 40 were taking statins, according to the U.S. Centers for Disease Control and Prevention (CDC).

One limitation to the eligibility article, the authors acknowledged, is that the study population was predominantly white, so the results may not be generalizable to other ethnic groups.

In addition, Dr. Gaziano noted, these findings don’t dictate that eligible individuals should automatically be issued a prescription.

“The decision to initiate statin treatment for adults without CVD should ultimately be informed by both evidence-based policies and patient preferences,” the authors wrote.