About 12.8 million more adults would be eligible for statin drugs under new guidelines designed to help doctors prescribe the cholesterol-lowering therapies, which should lead to risk discussions with their physicians to determine if it is an appropriate treatment, say guideline writers and the American Heart Association.

The 12.8 million number was released in a study – the first reviewing the guidelines since their release in November — published March 19 in the New England Journal of Medicine. The study used population samples to determine the number of adults age 40 to 75 who would be eligible for statins such as atorvastatin (Lipitor), simvastatin (Zocor), rosuvastatin (Crestor) and others.

The analysis, led by Duke University biostatistician Michael Pencina, Ph.D., compares eligibility under old guidelines and the new ones issued in November by the American Heart Association and the American College of Cardiology.  The results show half the U.S. population in that age range – 56 million – would fit the profile to consider a statin, while 43 million did under the old guidelines originally created in 2001. Both numbers include 25 million people currently taking statins.

Donald M. Lloyd-Jones, M.D., chair of the Department of Preventive Medicine at Northwestern University and one of the guideline authors, said the new analysis provides a good, objective look at who may be eligible for consideration of a statin and a discussion of risk.

“With one in three Americans dying of a preventable or postponable cardiovascular event, and more than half experiencing a major vascular event before they die, evidence-based guidelines that recommend statins be considered for about half of American adults seem about right,” he said. “We currently recommend that about 70 million Americans be treated for hypertension, so recommending that about 50 million should be considered for statins also seems about right.”

The analysis does conclude that about 475,000 heart attacks and strokes could be prevented in the next decade with the application of the new guidelines.

“If statin therapy then reduces the relative cardiovascular risk by 25 percent, as suggested in meta-analyses of statin use in primary prevention, a total of approximately 475,000 future cardiovascular events would be prevented,” the study says. “More than 90 percent of this potential benefit would occur among older adults.”

Lloyd-Jones said the latest report’s authors recognized the statin eligibility numbers are “maximum” estimates because the guidelines recommend physicians use a new risk calculator as a starting point for a discussion, not to mandate a prescription.

The analysis and the guidelines should be seen as part of a much larger picture, said American Heart Association President Mariell Jessup, M.D.,  medical director of the University of Pennsylvania’s Heart and Vascular Center. The guidelines were part of a “suite” of recommendations issued this past fall to take a holistic look at all aspects of prevention.

“One of the myths is that these guidelines are mandating statins,” Jessup said. “This suite of guidelines are about lifestyle and managing weight and cholesterol and what kind of diet to eat. That’s been the message of the American Heart Association for a long time. … What we are really focusing on is how we can manage our lifestyle changes so we don’t have to take drugs for cholesterol or hypertension and manage it through prevention.”

The guidelines suggest everyone with known heart disease should be taking statins – as well as adults over 40 without a known cardiovascular disease, but who have a 10-year risk of heart attack or stroke of 7.5 percent or more.

The old guidelines suggested doctors should prescribe cholesterol-lowering drugs when a patient’s 10-year risk was above 20 percent and had an LDL, or “bad” cholesterol reading above 130.

Also under the new guidelines, statin therapy is urged for diabetics over 40 and for people with LDL cholesterol over 190.

The crux of the new guidelines is the way 10-year risk for a heart attack or stroke is being calculated. The new calculator plugs nine factors, including blood pressure, smoking status and cholesterol levels, into an equation. It also now represents risk for women and African-Americans – two groups that were underrepresented before, Jessup said.

“Physicians have always been asked to calculate risk,” she said. “One of the reasons we are capturing more people at risk is that we have broadened the population the calculation was based on, that is reflecting reality.”

“The bottom line always is that one in three Americans will die from cardiovascular disease and stroke,” Jessup said, “and shouldn’t we be more aggressive in preventing this?”

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