Statins, drugs that lower LDL (bad) cholesterol levels, are perhaps the most widely prescribed pharmaceuticals in the United States. Currently nearly 43 million US adults 38 percent of Americans between the ages of 20 and 80 are prescribed statins. That number could increase substantially, according to a recent report in the New England Journal of Medicine, since the 2013 guidelines for statin use expand their potential application.
Using data from the National Health and Nutrition Examination Surveys (NHANES) of 2005 to 2010, Dr. Michael J. Pancina from the Duke University Clinical Research Institute and a multi-center group of colleagues representing the American Heart Association and the American College of Cardiology estimated the effect of the latest guidelines on the number of people who would be prescribed these drugs.
The previous guidelines recommended statin therapy for patients with LDL cholesterol levels greater than 100 mg per 100 mL of blood, with cardiovascular disease, or diabetes. In addition, those without current disease and a 10-year risk of coronary heart disease might also be candidates for preventive therapy.
The new guidelines expand the treatment recommendations for people with established disease regardless of LDL levels. For additional primary prevention, statin therapy would be recommended for anyone with an LDL level greater than 70 mg per 100 mL of blood if they also have either diabetes or a 10-year risk of cardiovascular disease of 7.5 percent or greater (as determined from a risk-calculation tool on the AHA and ACC websites).
According to the older guidelines, the investigators found that 42 percent of the people in the NHANES samples were receiving or would be eligible for statin therapy. Under the new guidelines, an additional 16 percent would be eligible for these drugs Of the 115 million Americans between the ages of 40 and 75, there would be 56 million eligible individuals instead of 43 million.
In their discussion, the authors stated: These new treatment recommendations have a larger effect in the older age group (60 to 75 years) than in the younger age group (40 to 59 years). Although up to 30% of adults in the younger age group without cardiovascular disease would be eligible for statin therapy for primary prevention, more than 77% of those in the older age group would be eligible.
As we reported when the guidelines first came out, cardiologist Dr. Steven Nissen of the Cleveland Clinic, had this perspective, as reported on CNN: This is an enormous shift in policy as it relates to who should be treated for high levels of cholesterol. For many years, the goal was to get the bad cholesterol levels or LDL levels below 100. Those targets have been completely eliminated in the new guidelines, and the threshold for treatment has been eliminated. The reporter paraphrased him thus: The biggest change from the old guidelines, he says: Ignore the numbers.
ACSH s Dr. Gilbert Ross s take was this: It s important to note that this study in no way estimated the potential effect of this expansion of statin use in the American population. Until these guidelines are followed by prescribers and patients for several years, we will not know the extent to which the rate of cardiovascular disease and deaths from it decease if at all. I do fear, however, that the complexity of the new guidelines will make their uptake a burden, delaying their impact, for good or ill.
