What’s in a Number? Random Thoughts About the New Cholesterol Guidelines
If you haven’t heard about the new cholesterol guidelines published last week by the American Heart Association (AHA) and the American College of Cardiology (ACC), you could not have been listening to the news on radio or television or reading any newspapers. Let me try to enlighten you.
Background
In response to the high prevalence of heart disease in the U.S., quite a number of years ago, there were major efforts to improve things. Studies showed that risks for the development of heart disease were strongly related to the blood level of cholesterol. The Centers for Disease Control and Prevention (CDC) had been successful in developing a standardization program for measurement of various cholesterol components- e.g, LDL-cholesterol (the “bad cholesterol”) and HDL-cholesterol (the “good” cholesterol). This meant that wherever the test was performed, it was likely to be reliable. At the same time, the major professional organizations centered around heart issues, pushed strongly for much more cholesterol testing and for treatment of patients whose cholesterol levels put them at high risk for the development of heart and blood vessel diseases (e.g, peripheral vascular disease and stroke). There were aggressive campaigns aimed at both physicians and the public to “know their numbers.” None of this would have mattered much if we didn’t have wonderful new drugs, the “statins,” which had a profound effect on both cholesterol levels and patients’ risks for the development and progression of heart and blood vessel diseases. One key aspect of this education program was the development of specific cholesterol goals. At first, the goal was a serum LDL-cholesterol < 130 mg/dl. Then, the goals became lower and lower- to 100 mg/dl, and finally, to a level < 70 mg/dl in people with pre-existing heart disease or at particularly high risk (e.g., people with diabetes or with strong family histories of heart disease). At present, more than 40% of people in the U.S. over 40 years of age are being treated with one of the statins. Over the past 20-30 years, there has been a rather dramatic decrease in the prevalence of heart disease in the U.S. Most experts believe that in large part the reason for the change is related to cholesterol testing and treatment with statins and having specific numbers to aim for.
The New Guidelines
So, the new guidelines are basically: “forget about what we told you. Let’s stop doing so much cholesterol testing and just treat people with statins if they are at high risk based on our new risk calculator.” The AHA and ACC developed a risk calculator which people can go to on-line to determine if they should be treated with a statin. Only a single blood test is needed; if the LDL-cholesterol is > 190 mg/dl, treatment is indicated regardless of what the risk calculator says. Sounds simple, right?
Oops
Well, shortly after the press release announcing the new guidelines, we learned that the risk calculator was flawed and would more or less overestimate a person’s risk by 100% or more (the way the calculator worked was that if a person had a 7.5% or greater risk for the development of heart disease over the next 10 years, he or she was supposed to be a candidate for statin therapy). So, now everything is up in the air and the AHA and ACC are clueless what to do about the mess. This never should have happened. But it did. In my opinion, we should take several steps backward and “regroup.” I believe that however flawed the earlier number guidelines were, they led to extraordinary improvements in risks for heart disease. The idea that we would treat people with expensive medications that have significant side effects without having some means of tracking their degree of success in improving their risks for heart disease seems bizarre. Maybe, we should just put Lipitor in the water, just like we do for fluoride?
I think that knowledgeable physicians, generalists as well as cardiologists likely will ignore these new guidelines and evaluate patients one at a time and with patients as “partners,” make smart decisions whether a person should or shouldn’t be treated with a statin without the benefit of the new on-line calculator. If you are interested in this stuff, you can read about it in a series of excellent articles written in the NYT by Gina Kolata, starting Wednesday, November 13, 2013, in a front page article entitled: “Experts reshape treatment guide for cholesterol.” There is also an excellent article on the subject in the WSJ the same day (“Strategy to cut heart risk receives a major shake-up”) and written by Ron Winslow. You might also check out the follow-up article written by Gina Kolata in the NYT, Monday, November 18, 2013, and entitled: “Risk calculator for cholesterol appears flawed.” This article also hit the front page.