Statin Guidelines Demystified

For nearly 30 years, cholesterol-lowering medications, known as statins, have been available to reduce the risk of heart attacks in individuals who had suffered previous heart attacks and who have high levels of LDL cholesterol, the form associated with vascular disease. The first of this class of medications, lovastatin, was approved by the U.S. Food and Drug Administration in 1987, according to the National Institutes of Health.

Since then, research has uncovered additional benefits of statin therapy, including the prevention of a first heart attack or stroke in people with a high risk for these events because of their higher-than-normal LDL cholesterol levels. With these findings, though, comes varying opinions of when the drugs should be prescribed for maximum benefit.

Differing Statin Guidelines

In fact, a report published in the Journal of the American Medical Association in April highlights a significant difference between the number of people who are prescribed statins under guidelines suggested by the American College of Cardiology (ACC) and the American Heart Association (AHA) and the number of people who receive statins following the United States Preventive Services Task Force (USPSTF) guidelines. Nearly 9.3 million fewer individuals would be prescribed statin therapy under the USPSTF guidelines, the study found.

Some analysts suggest the more stringent ACC/AHA guidelines may lead to over-prescribing. Doctors say guidelines simply help them make educated decisions that can save lives.

“What we’ve seen over the past three decades is that statins work to decrease cholesterol levels,” said Jonathan Fialkow, M.D., a cardiologist with Miami Cardiac & Vascular Institute and certified lipidologist by the American Board of Clinical Lipidology. “And they do so safely, without adverse effects on major organs, such as the brain and liver, or on the quality of life.”

Dr. Fialkow, chief clinical integration officer for Baptist Health, warns not to choose guidelines to follow just because they seem more conservative in terms of the number of people who need statin therapy. Instead, he suggests a candid conversation with a cardiologist.

The Purpose of Guidelines

“These two sets of guidelines use arbitrary thresholds to determine who should receive statins to prevent heart attacks or strokes over the next 10 years,” he said. “The ACC/AHA guidelines set ‘high-risk’ at a 7.5 percent chance of an event in that time period, whereas the USPSTF’s definition of ‘high-risk’ is a 10 percent chance of a stroke or heart attack in the next 10 years, accompanied by another risk factor such as diabetes, high blood pressure or heart disease.”

At best, Dr. Fialkow says these guidelines indicate that 7.5 people or 10 people out of 100 with similar risk factors will have a heart attack or stroke over the next decade without intervention. But, the guidelines can’t say who those individuals will be. That means doctors and their patients must decide if that 7.5 percent or 10 percent chance is too high to risk not taking the statin.

“Guidelines are simply tools that we use to help us make decisions,” he said. “If we knew the 7 people who were going to have a heart attack in the next 10 years, we’d simply prescribe those people the statin and help the others with lifestyle changes, such as eating nutritious foods, staying physically active and getting enough sleep to help their bodies function properly.”

As more research unveils what factors into heart attacks and strokes, diagnostic tools may help more closely identify those individuals who will most likely have a heart attack or stroke. Calcium scoring, for example, has proven helpful in further identifying individuals’ risks for heart attack or stroke, Dr. Fialkow says. But, not everyone is a candidate for calcium scoring.

Making an ‘Educated Decision’

“We have to take what we currently know about heart attack and stroke and make an educated decision about a person’s risk. That’s what these guidelines help us do,” he said.

No matter what guidelines your doctor recommends following, it’s important to understand that statins are proven to work, are extremely well tolerated and aren’t expensive, Dr. Fialkow says. Knowing these medications can help prevent a life-threatening heart attack or stroke over the next 10 years of your life may be all you need to know to help you make a decision.

“There’s no right or wrong answer,” he said. “It’s the best we have in medicine now.”