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New Heart Drug Guidelines Efficient and Cost Effective

JAMA studies confirm value of statin therapy

Two studies have shown that new guidelines for prescribing cholesterol-lowering medications are efficient and cost-effective, according to a Reuters report.

The research, published in JAMA, examined the 2013 recommendation that people 40 to 75 years of age with at least a 7.5% risk of having a heart attack or stroke over the next 10 years should receive statin therapy.

In addition to this population, the 2013 guidelines –– issued by the American College of Cardiology and the American Heart Association –– recommend the use of statins for people with cardiovascular disease, for diabetics between 40 and 75 years of age, and for adults with high levels of “bad” low-density lipoprotein cholesterol.

Senior author Dr. Udo Hoffmann and his colleagues at the Harvard Medical School say the new guidelines could result in 12.8 million more Americans being treated with statins, which include atorvastatin (Lipitor, Pfizer), rosuvastatin (Crestor, AstraZeneca), and simvastatin (Zocor, Merck).

The researchers looked at 10 years of data from 2,435 statin-naïve people. Under the new guidelines, 39% would have been eligible for statin therapy compared with 14% under the old guidelines. During the course of the study, 74 patients (3%) had cardiovascular events, including heart attacks and strokes.

When the researchers examined the data more closely, they found that cardiovascular events had occurred significantly more often in patients who would have been advised to take statins under the new guidelines. Specifically, the rate of heart attacks and strokes was 6.3% in the group that would have been candidates for statin treatment compared with 1.0% in patients who would not be statin candidates under the new guidelines.

The researchers say their findings show that the new guidelines were more accurate and efficient at identifying people with an increased risk of cardiovascular disease. Applying their results to the U.S. population, the researchers estimate that between 41,000 and 63,000 cardiovascular events would be prevented over 10 years if the new guidelines were followed.

Hoffmann cautioned, however, that the new results are based on a predominately white population. The risk calculator used for the new guideline considers race and ethnicity, he said. Experts have criticized the risk calculator for overestimating people’s risk for heart disease.

In a second study, researchers at the Harvard School of Public Health also found that the new guidelines were cost-effective.

Using a computer simulation, Dr. Ankur Pandya and colleagues found that the 7.5% risk threshold over 10 years would cost approximately $37,000 per quality-adjusted life year (QALY) gained. QALY is a standard measure of how much a treatment or intervention costs to earn 1 year of healthy life. In general, policymakers historically view interventions costing less than $50,000 per QALY as cost-effective.

The researchers said risk thresholds lower than 7.5% would be acceptable if interventions costing $100,000 or $150,000 were considered cost-effective.

Based on existing evidence and the new reports, Dr. Phillip Greenland of the Northwestern University Feinberg School of Medicine in Chicago and Dr. Michael Lauer of the National Heart, Lung, and Blood Institute in Bethesda, Maryland, call the 7.5% threshold justified and possibly too conservative.

“There is no longer any question as to whether to offer treatment with statins for patients for primary prevention, and there should now be fewer questions about how to treat and in whom,” they write in an editorial.

Sources: Reuters; July 14, 2015; and JAMA; July 14, 2015.


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