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Millions more now eligible for statins under new cholesterol guidelines
The 2013 guidelines of the American College of Cardiology and American Heart Association for the treatment of cholesterol increase the number of US adults eligible for statin therapy by 12.8 million, compared with the prior guidelines.
According to a new report, the increase in those eligible for statins is mostly among older adults aged 60 to 75 years without CVD.
Michael J. Pencina, PhD, from Duke Clinical Research Institute and colleagues reviewed data from the National Health and Nutrition Examination Surveys (NHANES) of 2005 to 2010, which was selected because it is designed to provide a representative sample of the US civilian noninstitutionalized population, according to the study background.
Results extrapolated
The researchers obtained data from 3,773 survey participants aged 40 to 75 years who had fasting data available and triglyceride levels <400 mg/dL. They determined the proportion of the participants that would be eligible for statin therapy under the new ACC/AHA guidelines for cholesterol management updated in 2013 and under the guidelines of the Third Adult Treatment Panel (ATP III) of the National Cholesterol Education Program updated in 2004. The results were then extrapolated to the population of 115.4 million US adults aged 40 to 75 years with triglyceride levels <400 mg/dL.
Overall, 56 million US adults, or 48.6% of the population, would be eligible for statin therapy based on the ACC/AHA guidelines compared with 43.2 million (37.5%) based on the ATP III guidelines, an increase of 12.8 million people since publication of the new guidelines.
The researchers calculated that 10.4 million of the 12.8 million adults eligible for statin therapy would occur among adults without CVD. Among adults aged 60 to 75 years without CVD and not currently receiving statin therapy, statin eligibility jumped from 30.4% under the ATP III guidelines to 87.4% under the ACC/AHA guidelines for men and from 21.2% under the ATP III guidelines to 53.6% under the ACC/AHA guidelines among women.
Ten-year risk a major factor
The researchers wrote that this effect “would largely be driven by an increased number of adults who would be classified solely on the basis of their 10-year risk for a [CV] event. Those who would be newly eligible for statin therapy include more men than women and persons with a higher [BP], but a markedly lower level of [LDL].”
The new ACC/AHA guidelines recommend statin therapy for more adults expected to have future CV events, but also many adults who would not have future events, the researchers wrote. In that guideline, statin therapy is recommended for four groups: people with atherosclerotic CVD, people with LDL ≥190 mg/dL, people aged 40 to 75 years with type 2 diabetes and people aged 40 to 75 years with an estimated 10-year risk for CVD ≥7.5%, as determined by a risk calculator developed for the guidelines.
According to Pencina and colleagues, eligibility may not translate into treatment recommendation for all people, because “the new guidelines call for an informed risk-benefit discussion between patient and physician before the initiation of statin therapy” and “a lack of universal implementation” is possible.
Disclosure: See the full study for a list of the researchers’ relevant financial disclosures.
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These findings are very interesting. NHANES is the most appropriate study population for estimating effects at the level of the total US population. I believe that statins are underprescribed to younger patients who might already harbor an increased burden of atherosclerosis and are overprescribed to older patients based on their age alone. One of the biggest concerns I have is that we may be treating a lot of older adults (for example, men older than 60 years) who don’t have any risk factors for CHD outside of their age.
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These data are a powerful demonstration of the real-world effect of the new ACC/AHA guidelines, which will mean many more statins for many more people of older age. While there will no doubt be a real benefit with respect to CV events (a priority for the guideline writers), these data show that this may be at the cost of increased exposure to statins and their adverse effects in those who will not ultimately benefit. However, in the context of generic potent statins, the effect on the overall health of the population is likely to be favorable.
This study extrapolates findings from a representative sample of the US population, NHANES. Although there have been some recruitment problems with NHANES, there is no better sample available for the US population. This sample allows the researchers to accurately estimate the number of US adults eligible for statin therapy. The findings are rigorous and can be expected to be very close to the truth. Although the actual numbers may differ slightly, the message — that many more people are now eligible for statins — is accurate. Thus, I agree with the findings of the researchers. In fact, given the methods applied, there is little room for debate or disagreement.
The definition of ‘overprescription’ is inherently subjective. If one follows the guidelines — and most doctors do, which is why this analysis is so important — then there is no ‘overprescription.’ The numbers derived from this study are exactly the numbers who are eligible for statin prescription based on the guidelines, old and new.
Certainly, these findings have implications for modifications to the new risk score. Indeed, many have been concerned about the overestimation of risk with the new score. This overestimation may account for a significant proportion of the excess 13 million individuals now eligible for statin therapy. Modification of the risk score could mean that the actual numbers of newly eligible US adults will ultimately be less than 13 million. However, I believe that these data do not inform modification of the cholesterol guidelines themselves, as they do not add any new data which would change the recommendations of the guideline writers. Indeed, also using NHANES data, the guideline writers themselves expected that many millions of additional adults would be eligible. The guideline writers expected this and would not be surprised by the findings.