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New heart guidelines would qualify 12.8M more for statin therapy

By Sabriya Rice
Posted: March 19, 2014 - 8:30 pm ET

More than half of adults between ages 40 and 75 who need help managing cholesterol would be eligible for statin therapy for the prevention of heart disease on the basis of the newest American College of Cardiology and American Heart Association guidelines, finds an analysis published Wednesday. The new guidelines have the potential to increase the net number of new statin prescriptions by 12.8 million.

Extrapolating from a data sample pulled from the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, researchers estimated the number of Americans for whom statin therapy would be recommended on the basis of new ACC/AHA guidelines released in November, and compared that with the number that would qualify under the previous guidelines from the National Heart, Lung and Blood Institute's National Cholesterol Education Program. The guidelines differ substantially, the report noted.

Investigators concluded that 48.6% of adults within the 40 to 75 age range would be eligible for statin therapy based on the new ACC–AHA guidelines, while only 37.5% were eligible under the previous recommendations. With more than 115 million U.S. adults estimated to be between the ages of 40 and 75, the analysis suggests the total number of potential statin users could expand to 56 million, and the majority would be above age 60. Results of the analysis were published Wednesday in the New England Journal of Medicine.

“That's a huge number,” said study co-author Michael Pencina, a professor of biostatistics at Duke University who says he was most surprised by the potential increase in people over age 60. Among older men who were not currently taking statins and did not have cardiovascular disease, just more than 87% would be candidates for statin therapy compared to about 30% under the previous guidelines, the report found.

"We anticipated that the impact would be age-dependent, but not to the degree observed,” he said. The analysis also included researchers from Boston University and the Harvard Clinical Research Institute in Boston, KenAnCo Biostatistics of San Antonio and McGill University, Montreal.

When the new guidelines were published last year, several groups weighed in with opinions about the potential impact, including Dr. Rita Redberg, editor of JAMA Internal Medicine.

The new guidelines, “essentially declared, in one fell swoop, that millions of healthy Americans should immediately start taking pills—namely statins—for undefined health 'benefits,' ” she wrote in an New York Times op-ed. “This may sound like good news for patients, and it would be—if statins actually offered meaningful protection from our No. 1 killer, heart disease; if they helped people live longer or better; and if they had minimal adverse side effects. However, none of these are the case,” she said.

That's an issue also noted by Pencina. “Heart disease and cardiovascular disease, in general, is a function of age and the guidelines say let's treat them,” he said, but the question becomes, “Do you really need to treat all of these patients?”

Though statins are generally considered to be safe, the Food and Drug Administration issued safety guidance on the use of statins in 2012, advising about the possible risk of cognitive impairment; raised blood sugar levels and the development of Type 2 diabetes; and muscle damage, saying the labels for popular statins would be changed to reflect these new concerns.

Follow Sabriya Rice on Twitter: @MHSRice

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