If statin guidelines released last fall were followed to the letter, nearly all men between ages 60 and 75 would be taking a cholesterol-lowering drug even if they didn't have heart disease, according to a new study that analyzed the impact of the controversial recommendations.
The Duke University-led study projected that following the guidelines would result in nearly 13 million more Americans taking statins, most of them 60-plus. Among adults 60 to 75 without heart disease and not on statins, 87 percent of men (up from 30 percent now) and 54 percent of women (up from 21 percent now) would be candidates for the daily drugs, the analysis found.
"The changes for both men and women in the older age groups were huge compared to those between the ages of 40 and 60," lead author Michael J. Pencina, director of biostatistics at the Duke Clinical Research Institute in Durham, N.C., said in a statement.
The study was published online Wednesday in the New England Journal of Medicine.
The guidelines, announced in November by a national committee of heart experts, recommended that doctors scrap the old way of prescribing statins - based primarily on the numbers from a cholesterol blood test - and instead look at four high-risk categories for having either a heart attack or stroke.
Few physicians disagreed with three of the categories, namely a diagnosis of heart disease or diabetes plus a high cholesterol level, but a fourth one - which used a special online calculator to estimate a person's 10-year likelihood for a heart attack or stroke - sparked widespread criticism.
The calculator took into account factors such as smoking and obesity; patients determined to have a 7.5 percent or greater chance of having heart disease within 10 years would be considered eligible for taking a preventive statin. Critics said the calculator overestimated the risk and would result in tens of millions more people on the drugs.
Pencina and his colleagues from McGill University, in Montreal, and Boston University wanted to provide hard numbers for how many people would be recommended to take statins under these guidelines. They used a representative sample of about 3,800 federal health survey participants who were between 40 and 75 and had provided detailed medical information, including fasting cholesterol levels from blood tests.
Based on the researchers' findings, the number of Americans taking statins would rise from 43 million to 56 million, nearly half the U.S. population between 40 and 75.
While most cardiologists agree that statins are useful in preventing a further heart attack or stroke, there's greater disagreement over whether statins should be prescribed as a precaution in adults who show some risk factors but don't already have heart disease.
There's also concern over statins' side effects, which can include muscle pain, cognitive impairment, liver dysfunction and increased risk of diabetes. Older patients in particular seem to suffer more side effects.
"If our goal is to help people feel better, live longer and have less heart disease, putting millions more on statins is not going to do that," cardiologist Rita Redberg, M.D., of the University of California, San Francisco told USA Today. She believes there should be more emphasis on diet and exercise to help lower heart disease risk before turning to prescription drugs.
On the other hand, Pencina points out that his team's study is based on the assumption that the guidelines would be followed to the letter, whereas, in real life, people may decline the drugs and try lifestyle changes instead.
"Recommendations are just that - recommendations," he said. "These guidelines correctly call for a thorough discussion between the doctor and patient about the risks and benefits of statins. It's not like everybody who meets the guidelines should all of a sudden go on statins."
Photo: Fuse/Getty Images
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