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Report: New Heart Guidelines Could Mean Unnecessary Statins for Millions of Americans

Treatment carries risk of diabetes

In 2013, revised guidelines from the American College of Cardiology and the American Heart Association (ACC/AHA) for the treatment of cholesterol expanded the indications for statin therapy for the prevention of cardiovascular disease.

The new recommendations represented a major change in assessing a person’s risk for heart disease. Instead of aiming to lower a patient’s “bad” low-density lipoprotein (LDL) cholesterol level to specific numeric targets, the guidelines ask doctors to use a new online calculator that factors in various characteristics, such as smoking and obesity, to predict an individual’s risk of heart disease.

Last fall, critics said the risk calculator overestimated the number of people in need of statin therapy.

Now, in a new study published online in the New England Journal of Medicine, experts estimate that the revised ACC/AHA recommendations could mean that 56 million people, or nearly half of the U.S. population between the ages of 40 and 75 years, would be eligible to take a cholesterol-lowering statin to prevent heart disease.

The authors used data from the National Health and Nutrition Examination Surveys of 2005 to 2010 to estimate the number, and to summarize the risk-factor profile, of persons for whom statin therapy would be recommended under the new ACC–AHA guidelines, compared with the guidelines of the Third Adult Treatment Panel (ATP III) of the National Cholesterol Education Program. They then extrapolated the results to a population of 115.4 million U.S. adults between the ages of 40 and 75 years.

The authors found that, recompared with the ATP-III guidelines, the new recommendations would increase the number of U.S. adults receiving or eligible for statin therapy from 43.2 million (38%) to 56.0 million (49%). Importantly, most of this increase in numbers (10.4 million of 12.8 million) would occur among adults without cardiovascular disease.

Further, among older adults between the ages of 60 and 75 years without cardiovascular disease who are not receiving statin therapy, the percentage that would be eligible for such treatment would increase from 30% to 87% among men and from 21% to 54% among women. According to the authors, this effect would be driven largely by an increased number of adults who would be classified solely on the basis of their 10-year risk of a cardiovascular event.

Individuals who would be newly eligible for statin therapy include more men than women and persons with a higher blood pressure but a markedly lower level of LDL-C cholesterol.

The authors conclude that, compared with the ATP-III guidelines, the new guidelines would recommend statin therapy for more adults who would be expected to have future cardiovascular events, but would also include many older adults without cardiovascular disease.

Statin therapy has been associated with a variety of adverse effects, including an increased risk of developing diabetes.

Sources: NEJM; March 19, 2014; and Reuters; March 19, 2014.

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