DALLAS, – A new study advises physicians to fully understand the expanded benefits of the new cholesterol guidelines, citing that the new recommendations are likely to significantly raise the number of people under 45 and older than 65 who are prescribed cholesterol-lowering medications, according to a report in today’s Circulation: Journal of the American Heart Association.
The authors say that while there are trials to determine the benefit of cholesterol lowering in elderly populations, no formal studies are ongoing for younger patients. “The ability to generalize the primary prevention trial results, particularly to younger patients, must be explored,” according to the paper.
“The health policy implications of the guidelines should be considered and addressed along with their adoption,” says Donald O. Fedder, Ph.D., lead author of the study that examines the implications of the NCEP III guidelines on different population groups. “The new guidelines have increased the number of people eligible for drug treatment.”
According to National Cholesterol Education Program (NCEP) III guidelines published in 2001, people at higher risk for heart disease with LDL cholesterol levels (the “bad” cholesterol) of 130mg/dL or greater are eligible for cholesterol-lowering treatment. This replaced the NCEP II guidelines set in 1993, which set LDL levels of 160mg/dL or higher as the treatment-eligible criteria for the same individuals.
“We’re saying that there needs to be some caution,” says Fedder, who is professor of pharmacy and medicine at University of Maryland, Baltimore. “My concern is over-treatment, or that doctors will interpret the findings to mean that everybody needs to be treated to a level below 100 mg/dL. We must make certain that clinicians are instructed in the proper use of the guidelines.”
Researchers took a sample of people ages 20 to 79 years old from the third annual National Health and Nutrition Survey. They identified 13,589 people with known cardiovascular risk factors and LDL levels. Researchers then assessed the participants’ eligibility for drug therapy first using NCEP II guidelines (160mg/dL) and then the new NCEP III criteria (130mg/dL).
According to the study, a projected 15 million people ages 20 to 79 would be eligible for drug therapy under NCEP II guidelines. Of these, 51 percent were male and 49 percent female; 26 percent were younger than age 45 and 28 percent were 65 years or older. Under the new NCEP III guidelines, 36 million are treatment eligible; of these 55 percent are male and 45 percent female; 32 percent are younger than 56 and 27 percent are 65 or older. This represents a 140 percent increase in eligibility overall.
The new recommendations also alter the gender distribution of treatment-eligible patients – the number of women eligible for treatment increases 122 percent (from 7 to 16 million), while the number of treatment-eligible men increases 157 percent (from 8 to 20 million).
In looking at age distribution, the new guidelines incur a 131 percent increase among those 65 or older (from 4 to 10 million) and a 201 percent increase among those younger than 45 (from 4 to 12 million). Of those deemed eligible for treatment, 26 percent of males and 24 percent of females, 39 percent of those older than 65 and 14 percent of those younger than 45 would be targeted for LDL lowering to less than 100 mg/dL.
The study also raises other issues. Under NCEP II, treatment was indicated in roughly equal numbers of males and females; whereas under NCEP III, proportionally more men than women are eligible. “Although these differences in risk are factual, this runs counter to the current opinion that cardiovascular risk should be regarded as equally relevant in females and males,” according ot the study. Sidney Smith, M.D., chief science officer for the American Heart Association, says,
“The important message is that under the new guidelines, many more patients will benefit from cholesterol lowering therapy because their need for therapy is based on their individual risk of heart disease. It’s also important to remember that diet and exercise also lower cholesterol and are a valuable part of all treatment strategies.”
Co-authors are Carol E. Koro, M.D. and Gilbert J. L’Italien, M.D.
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