New Guidelines Boost Statin-Eligible Patients by 12.8 Million

Last autumn, the American Heart Association (AHA) and the American College of Cardiology (ACC) revised the guidelines for prescribing statins. Those drugs compromise the body’s ability to produce cholesterol, and are intended to prevent heart disease.

It was a controversial decision; some people questioned the science that would classify many more people as candidates for daily statin use, and some said the new guidelines would undermine more nuanced approaches to reducing cardiac events. We wrote about the situation in the December patient safety newsletter, “Spotlight on Statins.”

Earlier this month, the New England Journal of Medicine (NEJM) published a story quantifying just how many more Americans could be considered eligible to take statins – 12.8 million more than under the previous guidelines.

As explained in a story on Reuters.com, that figure amounts to 56 million people, or nearly half of all people in the U.S. between the ages of 40 to 75.

Holy pharma, Batman!

The new metrics, derived through a doctor’s use of an online calculator, deem that patients with a 7.5% or greater chance of having heart disease within 10 years fall into the eligible-for-statin category.

But the calculator was viewed with suspicion. Critics said it overestimated the number of people requiring statins, and many believed it would add millions of new statin users.

Indeed. Most of them, according to the NEJM, are people older than 60.

Cardiologist Steven Nissen from the Cleveland Clinic was one doctor who wanted to delay implementing the guidelines when they were issued in November. He told Reuters that the NEJM analysis reinforces some of his concerns.

The NEJM researchers reached the 12.8 million number using data from the National Health and Nutrition Examination Surveys (NHANES), which represent the U.S. population. They focused on 3,773 participants between the ages of 40 and 75 who had provided detailed medical information.

They compared recommendations for statin use under the new and old guidelines, and concluded that the new guidelines represented a 38% percent increase from the old ones. For people older than 60, 77% were recommended for statin use versus 48% before. For people ages 40 to 60, the increase from old to new guidelines was 27% to 30%.

“The biggest impact of the change is among older healthy men who are not on statins,” according to Reuters.com. “Under the earlier guidelines, some 30% of men age 60 to 75 were recommended for statin use. That number jumps to 87.4% percent under the new guidelines.”

For healthy women older than 60, the increase rockets from 21.2% to 53.6%.

Statins are already huge sellers – in 2012, about 255 million prescriptions were written for cholesterol-lowering drugs, including Crestor, Lipitor and Zocor. And, like all drugs, the benefits do not come without risks. Side effects can include muscle pain or weakness, decreased cognitive function, increased risk of diabetes, cataracts and sexual dysfunction.

Then there’s the psychological effect – some people are falsely reassured that if they take a statin, they don’t have to address lifestyle issues (diet, exercise, stress) that factor into heart problems.

Of course, not everybody who’s eligible for statin treatment based on the risk calculator would get a prescription, and many practitioners say that’s the point; that what the calculator concludes should be the basis not necessarily for a prescription, but for a discussion between doctor and patient of heart risk, and the range of measures one can take to lower it.

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