New cholesterol guidelines could boost number of US statin users by 12.8 million: study

According to study findings published in the NEJM on Wednesday, cholesterol management guidelines issued by the American Heart Association (AHA) and the American College of Cardiology (ACC) last November would increase the number of US adults eligible for statin therapy by 12.8 million. Cleveland Clinic cardiologist Steven Nissen, who had argued for a delay in implementing the guidelines, said the analysis "shows there is a huge expansion of the number of people for whom statins are recommended."

Researchers tested the application of the new guidelines, which called for a broader assessment a patient's risk for cardiovascular diseases and steered doctors toward a new online "risk calculator" that factors in characteristics, such as smoking and obesity to predict such risk, on a population-based sample. Using data from the National Health and Nutrition Examination Surveys of 2005 to 2010, investigators compared recommendations for statin use under the latest ACC–AHA guidelines versus the previous recommendations, focusing on 3773 participants who had provided detailed medical information. Results were then extrapolated to a population of 115.4 million US adults between the ages of 40 and 75.

The findings indicated that the number of adults either receiving or eligible to receive statin drugs would rise to 56 million, with the increase mostly seen among older adults without cardiovascular disease. Further, study data showed that among those aged between 60 and 75 who do not have cardiovascular disease and are not receiving statins, the percentage who would become eligible would increase from 30.4 percent to 87.4 percent for men and from 21.2 percent to 53.6 percent for women. "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," the authors said. However, among adults between 40 and 60, proportions of those who would be eligible for statin use would be similar at 29.7 percent and 27 percent, respectively, for the new and older guidelines.

The researchers noted that people who would be newly eligible for statin therapy include more men than women, as well as people with hypertension, but much lower levels of LDL cholesterol. They also found that, compared with the older guidelines, the new recommendations propose statin therapy "for more adults who would be expected to have future cardiovascular events, but would also include many adults who would not have future events."

When the updated guidelines were released late last year, a pair of Harvard researchers suggested the risk calculator over-predicted cardiovascular risk by 75 percent to 150 percent in populations they had tested. The AHA has stressed that the calculator was reviewed by many experts, but Nissen noted that it was never published in a peer-reviewed journal, saying "we are now for the first time really beginning to understand who this risk calculator will recommend for treatment." Nonetheless, study leader Michael Pencina acknowledged that not all people eligible for statin treatment under the new rules would necessarily get a prescription.

Neil Stone, who chaired the committee that issued the new guidelines, said the risk calculator was intended as a tool to inform doctors and patients about the potential need for treatment, adding that it "doesn't determine the statin prescription. It determines the need for a risk discussion."

For additional analysis, read Physician Views: How have cardiologists, internal medicine specialists and general practitioners reacted to the new AHA/ACC cholesterol management guidelines.

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