Two weeks ago, at the annual meeting of the American Heart Association, that group — in partnership with the American College of Cardiology — released sweeping new guidelines on drug treatments for the prevention of cardiovascular disease. Of the new recommendations contained within the guidelines, the one that is getting the most attention is a dramatic expansion in the number of people for whom statin drugs are recommended. Statins — the group of cholesterol-lowering drugs that includes atorvastatin (brand name Lipitor), simvastatin (Zocor), and rosuvastatin (Crestor) — were previously recommended for people with existing heart disease, and for those with at least a 10% to 20% risk of developing heart disease over the next 10 years. Under the new guidelines, statins are recommended for anyone with a 10-year risk level of at least 7.5%, and can be considered for anyone with a risk level of at least 5%. These numbers translate to millions more people taking statins in the United States — by one estimate, an increase of 70% in the number of healthy people taking the drugs.
A number of factors are used to estimate a person’s 10-year heart disease risk, including age, weight, cholesterol and other lipid levels, and whether someone has Type 1 or Type 2 diabetes. Previously, regardless of a person’s 10-year risk level, statins were only recommended for people without heart disease when their LDL (low-density-lipoprotein, or “bad”) cholesterol reached a certain level. Under the new guidelines, the LDL criteria for starting statins are eliminated, as are LDL targets once people start taking statins. This abandonment of LDL targets led the National Lipid Association, which was originally involved in creating the new guidelines, to withdraw its support for them before they were released; the group believes that evidence supports using LDL targets to help evaluate heart risk. This disagreement may arise from the fact that the doctors who led the development of the new guidelines — working, unpaid, for five years, according to a recent article in The New York Times — decided to use only data from randomized controlled trials to support their recommendations. While these trials are considered the “gold standard” of medical evidence, it is possible that examining other types of studies would have led to different recommendations.
Some experts believe that a 7.5% risk of heart disease over 10 years is too low to warrant taking statins. In an op-ed piece in the Times published just after the new guidelines were released, two doctors explained that according to a recent study one of them worked on, under the new guidelines, 140 people would have to be treated with statins to prevent just one stroke or heart attack, and even then, there would be no reduction in the rate of death or serious illness. They also noted that 18% of statin users experience side effects ranging from cataracts and sexual dysfunction to an increased risk of Type 2 diabetes and muscle pain and weakness (both discussed in Diabetes Flashpoints posts last year).
To make matters worse, many doctors believe that an online risk calculator that was developed along with the new guidelines — for which a doctor can enter data about a patient to get an estimate of his or her heart risk — greatly overestimates the actual risk of heart disease. According to two Harvard Medical School professors who compared the risk calculator with three major studies of heart risk, the calculator overestimates risk by 75% to 150%, depending on the traits of the person being analyzed. This may be because the risk calculator was based on older data; heart disease risk for people of the same age has fallen over the last couple of decades.
How do you feel about statins — would you be willing to take them, if you don’t already, based simply on your age and having diabetes? If you take statins, do you believe they have given you any benefit, or negative side effects? Do you suspect statins might have contributed to your developing diabetes, or worsening it? Are statins getting a bad rap because people never know when they’ve avoided a heart attack or stroke? Leave a comment below!