Patients in good cardiovascular health would be well advised to stay away for now from following the cholesterol guidelines issued last week by the nation's two leading heart organizations.
The guidelines are accompanied by an online calculator that appears to overestimate greatly the risk of heart attack or stroke that currently healthy individuals might face over the next decade. As a result, tens of millions of people could be prescribed cholesterol-lowering statin drugs that they don't really need.
The guidelines were issued last Tuesday by the American College of Cardiology and the American Heart Association. There is little disagreement that statins should be taken by patients who have already had a heart attack, or suffer from diabetes, or have extremely high levels of LDL, the "bad cholesterol."
The controversy is over the guidelines for patients who do not have those medical conditions and need to be protected against future risks. The guidelines recommend that nine pieces of personal and medical data about a patient, such as age, race and systolic blood pressure, be plugged into a new online risk calculator to generate a composite assessment of the risk of a heart attack, stroke or other cardiovascular diseases over the next 10 years.
If the risk exceeds 7.5 percent, the patient is supposed to take statins. Below 7.5 percent, patients don't need statins. Under that calculation, some 33 million people between the ages of 40 and 79 exceed that threshold and are eligible for treatment with statin drugs.
After the guidelines were published, two Harvard Medical School professors identified flaws in the risk calculator that apparently had been discovered a year ago but were never fixed, as Gina Kolata reported in The Times on Monday.
In a commentary to be published Tuesday in The Lancet, a leading medical journal, the professors estimate that as many as half of the 33 million do not actually have risk thresholds exceeding the 7.5 percent level. Other experts who have tested the calculator found absurd results; even patients with healthy characteristics would be deemed candidates for statins.
The authors of the guidelines contend that the critique of their work was flawed and stressed that the risk calculator was simply a tool to alert those who should seek advice from their doctors, not a mandate for them to take statins.
Statins are among the safest prescription drugs available, but they do have adverse side effects in some patients, including muscle pain and muscle damage; an increased risk of diabetes, especially in women; memory loss and confusion; cataracts; and, rarely, kidney or liver damage.
For patients who clearly need treatment, the benefits of statins will almost always outweigh the risks. But healthier patients will need to make a judgment, in consultation with their doctors, on whether these risks are worth taking without evidence they will benefit. They should probably wait until the heart organizations reassess their risk calculator, the possible flaws in it, and how best to fix them.
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