A couple of years ago, the American Heart Association and the American College of Cardiology revised the guidelines for prescribing statins, drugs that compromise the body's ability to produce cholesterol, to recommend that many more people take statins to prevent heart disease.
It was a controversial decision, as we described in our blog. Last week, the controversy was renewed when a couple of studies bolstered those guidelines.
When the guidelines for statin use were issued in 2013, one analysis estimated the market for the drugs would grow by 12.8 million more than under the previous guidelines, to about 56 million people, or nearly half of all people in the U.S. between the ages of 40 to 75.
To a lot of people, that sounded like medicating for medicating’s sake.
With the newly released studies in JAMA, (here and here), Dr. Harlan Krumholz, writing on NPR’s health blog, acknowledged, “You may be wondering what to do, if anything, about your cholesterol levels.”
Krumholz, a cardiologist, offers strong cred on the topic. He’s a professor of medicine at Yale and directs the Yale-New Haven Hospital Center for Outcomes Research and Evaluation. He’s known for his patient-centered approach to the practice of medicine. Thoughtful people do well to listen to whatever he has to say.
He summarized the change suggested in the 2013 guidelines as moving the focus for deciding whether to take statins from your blood cholesterol numbers to your overall risk of dying from coronary heart disease or having a heart attack or stroke. “The idea is that the higher your risk, the more you have to gain from these drugs. Conversely, the lower your risk, the less likely you are to benefit,” he wrote.
The controversy was about a change from reaching a target number to reduce risk to a less quantitative assessment of health.
One of the JAMA studies published last week, Krumholz said, compared the new guideline with the old guideline for their ability to identify people who would benefit from statin therapy. “The researchers,” he wrote, “found that the new guideline, with its emphasis on risks instead of targets, was more accurate and efficient in identifying people with an increased risk of cardiovascular disease.
“… they find that the new guideline identifies more people for treatment — but that they are people who are likely to benefit from treatment. This article strengthens the case for the wisdom of the change in approach to the decision to use statins.”
That reinvigorates the problem from two years ago — the definition of what constitutes high risk among people without known cardiovascular disease. “It recommends statin treatment for people with cardiovascular diseases, such as having had a heart attack or stroke, or for those with diabetes even if they have not had prior heart disease. For others, they recommend treatment if a person's risk is greater than 7.5% in the next 10 years.”
The other JAMA study looked at the financial implications of different thresholds for treatment. It found that the 7.5% risk threshold was, as Krumholz put it, “economically attractive compared with many other investments in health care. And, in fact, they found that even a risk as low as 4% was economically attractive for society.
“For people contemplating statin therapy, the cost is quite low anyway. Most statins are generic now, and several can be bought for only a few dollars a month.”
His takeaway, as usual, was patient-driven: “[T]he researchers' findings give further support to the efforts to base the decision on the patient's preferences. It is not unreasonable from an economic perspective to support treatment decisions for even those who have a low risk of cardiovascular disease (lower than 0.5% a year), the researchers are saying.”
Krumholz said that before deciding if statins make sense, people should contemplate known and unknown side effects of the drugs, “which are particularly important for those with low risk of heart disease and stroke and less likelihood of benefit.”
He said the drugs are generally safe. But, as we wrote last month, known side effects may involve muscle problems and impaired thinking among older people. Diabetes also might figure into an individual’s situation.
And, as Krumholz noted, “The unknown side effects are, well, unknown, but there is always a possibility that lifelong therapy will involve some issue that we have yet to discover.”
“In the end,” he concluded, “I don't believe the guidelines should dictate what people should do, but only suggest how they might think about their choices.
“One of the new studies endorses the idea that treating based on cardiovascular disease risk is better than treating based on some target level. The other one suggests that treatment based on risk should be available to even low-risk people if they want treatment. We should also be clear that for them, the benefit is small and could easily be offset by any aversion to taking medications or concern about side effects.
“For anyone, the decision should be about whether the potential benefit is big enough to you, based on your preferences, to make it worth taking a pill every day.”
For more information, see Patrick’s newsletter, “Spotlight on Statins.”