New Guidelines Extend Statins to 13M More Americans

March 19, 2014

DURHAM, NC – The new American College of Cardiology (ACC) and American Heart Association (AHA) guidelines for the treatment of cholesterol would increase the number of individuals eligible for statin therapy by nearly 13 million people, an increase that is largely driven by older patients and treating individuals without cardiovascular disease, according to a new analysis[1].

Among older adults, those aged 60 to 75 years old, 87.4% of men would now be eligible for the lipid-lowering medication, which is up from one-third under the old Adult Treatment Panel (ATP) III guidelines. For women of the same age, the percentage of those now eligible for statins would increase from 21.2% under ATP III to 53.6% with the new 2013 clinical guidelines.

The increase, say investigators, is the result of more patients being eligible based on their 10-year risk of cardiovascular disease.

"The real change is particularly in older individuals," senior investigator Dr Eric Peterson (Duke Clinical Research Institute, Durham, NC) told heartwire . "The guidelines add 13 million new people to treatment or who would be recommended to get treatment. If you look at where those patients are, the vast majority are the older population, those aged 60 to 75 years old. In that age group, we estimate that almost 80% of people would be recommended to be on a statin based on the new risk-based algorithm. That's a big change."

To heartwire , lead investigator Dr Michael Pencina (Duke Clinical Research Institute), a biostatistician, said the relative impact of age vs other risk factors is greater in the new risk-assessment model when compared with the Framingham risk score used in ATP III.

"Because we're treating more and more older people, what it does is increase the sensitivity of the guidelines, which means we're going to catch more people who would have developed cardiovascular disease and prevent more events," said Pencina. "But the price to pay for it is that we will be treating more people. So, increased sensitivity and decreased specificity."

The analysis, which applied the new clinical guidelines to an estimate of the US population using data from the National Health and Nutrition Examination Surveys (NHANES), is published March 19, 2014 in the New England Journal of Medicine.

Big Changes Merged Last Year

Presented and published last November, the new cholesterol guidelines caused quite a stir given their departure from previous iterations. As reported by heartwire previously, the guidelines abandoned the LDL- and non–HDL-cholesterol targets that recommended physicians treat patients with cardiovascular disease to a target of less than 100 mg/dL (or the optional goal of less than 70 mg/dL).

Instead of these targets, which the guideline authors said were not grounded in randomized, controlled clinical-trial data, the new guidelines identify four groups of primary- and secondary-prevention patients for physicians to focus their efforts to reduce cardiovascular disease events. And in these four patient groups, the new guidelines make recommendations regarding the appropriate "intensity" of statin therapy in achieving relative reductions in LDL cholesterol.

These four groups include individuals with clinical atherosclerotic cardiovascular disease, individuals with LDL-cholesterol levels >190 mg/dL, diabetic patients without cardiovascular disease aged 40 to 75 years old with LDL-cholesterol levels between 70 and 189 mg/dL, and those without evidence of cardiovascular disease, an LDL cholesterol level 70–189 mg/dL, and a 10-year risk of atherosclerotic cardiovascular disease >7.5%.

To heartwire , Pencina said there was a lot of media hype and speculation last November as physicians and the general public grappled with the changes. Rather than "guess" at what the guidelines would look like in the general population, the researchers extrapolated eligibility for statin therapy using data from 3773 patients enrolled in NHANES.

Of the 115 million adults aged 40 to 75 years old in the US, approximately 43 million (37.5%) could receive or be eligible to receive a statin using the ATP III guidelines. When the ACC/AHA cholesterol guidelines were applied, however, this number increases to 56 million (48.6%). The researchers estimate that 14.4 million adults would be newly eligible for statin therapy, a number that is higher than 12.8 million because 1.6 million adults previously eligible with ATP III would no longer be eligible for statins.

Although the new guidelines increase the number of eligible statin users across all four of the new treatment categories, the largest increase in use would be in primary prevention. Of the 12.8 million additional people treated if the ACC/AHA guidelines were applied, 10.4 million of these would be adults without evidence of atherosclerotic cardiovascular disease (but with a 10-year risk >7.5%), the primary-prevention population. The increase in statins for primary prevention is largest among men, although the number of female primary-prevention patients also increases.

The researchers also looked at patients aged 40 to 59 years and those aged 60 to 75 years old without cardiovascular disease and noted a substantial difference in statin eligibility between ATP III and the ACC/AHA guidelines. While the number of adults aged 40 to 59 years old eligible for primary-prevention therapy is similar between the two guidelines, 77% of adults aged 60 to 75 years would be treated with a statin under the ACC/AHA guidelines. This percentage is up from the 48% of older adults who would be treated with ATP III.

To heartwire , Pencina said that given the lowered threshold for risk at >7.5%, as well as the inclusion of stroke in the risk-assessment model, he was not surprised there would be more people eligible for statin therapy. He was surprised, however, at the disproportionate increase of older statin-eligible patients.

"The other 'big-headline' number is when you look at men who are not on statin therapy right now, those aged 60 to 75 years old, [and] 87% of them are now eligible for statin therapy," he said in reference to primary prevention. "Older men can get recommended for statins based on age alone. In women, in comparison, it's now 54%. So almost every man and every other woman between 60 and 75 years old, if they're not taking a statin already, they should be."

The number of diabetic patients eligible for statin therapy under the new guidelines would increase from 4.5 million to 6.7 million, an increase that is the result of the lower LDL-cholesterol treatment threshold.

What About Younger At-Risk Patients?

Dr Brendan Everett (Brigham and Women's Hospital, Boston, MA), who was not involved in the analysis, told heartwire the increase in the number of eligible patients is not surprising, but he is happy the study was performed so that cardiologists are aware of the numbers and characteristics of patients newly eligible for statin therapy.

He pointed out that among the newly eligible patients for statin therapy, the median LDL-cholesterol level was 105 mg/dL. "That means that half of these patients have an LDL-cholesterol level less than 105 mg/dL," said Everett. "My bias is that statins are likely to work in this population but, strictly speaking, this question hasn't been tested in clinical trials."

He said the trial that most closely approximates these patients is the JUPITER trial, a study that enrolled and treated patients with LDL-cholesterol levels less than 130 mg/dL. The JUPITER patients, however, also had an elevated C-reactive protein (CRP) levels, an additional marker of cardiovascular risk. The median LDL-cholesterol level in JUPITER was 108 mg/dL.

To heartwire , Peterson said that a treatment approach that focuses on the 10-year risk of cardiovascular disease, rather than on LDL-cholesterol levels, might very well be justified in older patients, but there is still a need for clinical trials to demonstrate that this approach is appropriate. For now, the recommendation to treat those with a 10-year risk >7.5% remains somewhat controversial. Given that nearly 80% of adults aged 60 to 75 years would be treated, it remains unclear if all these patients will benefit from treatment, he said.

For Peterson, another unknown is the younger patient with elevated LDL-cholesterol levels. These patients might not qualify for statin therapy based on the 10-year risk score even though their lifetime risk is high. "In the next few years, they're unlikely to have a coronary event, but based on the current guidelines, they wouldn't be recommended for therapy," he said. "To be honest, everything I would look at from the epidemiological data would support the idea that these people ought to be treated more aggressively."

Pencina reports payments from McGill University Health Center for work related to analyses of Framingham data and payments from Abbvie for serving on the data safety and monitoring board of a trial of lipid-lowering compound. Peterson reports grant support from Eli Lilly and Janssen and personal fees from Boehringer Ingelheim. Everett has no disclosures.

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