The long-awaited American College of Cardiology (ACC) and American Heart Association (AHA) guidelines on treatment of high blood cholesterol(circ.ahajournals.org) to reduce atherosclerotic cardiovascular risk in adults may significantly shift how family physicians treat patients.
The updated cholesterol guidelines, which were published online Nov. 12 in the AHA's journal Circulation, suggest physicians use a new risk assessment tool and grading system to determine who qualifies for statin treatment. The changes could significantly increase the number of people taking the cholesterol-lowering drugs.
In addition, guidelines on screening for(circ.ahajournals.org) and managing cardiovascular risk(circ.ahajournals.org), as well as on identifying, evaluating and treating(circ.ahajournals.org) obesity in adults, were published the same day in AHA's journal Circulation.
- New American College of Cardiology (ACC) and American Heart Association (AHA) treatment guidelines for high blood cholesterol in adults suggest physicians use a new risk assessment tool and grading system to determine who qualifies for statin treatment.
- The ACC/AHA also released three other guidelines: two on screening for and managing cardiovascular risk, and one on the identification, evaluation and treatment of obesity.
- The AAFP is reviewing the guidelines for possible endorsement and likely will publish its determinations during the first quarter of 2014.
According to Doug Campos-Outcalt, M.D., M.P.A., of Phoenix, clinical methodologist to the AAFP's Commission on the Health of the Public and Science (CHPS), the proposed changes may be warranted, but the Academy currently is not in a position to endorse the updates. Although Patrick McBride, M.D., M.P.H., of Madison, Wis., served as the lone family physician member on the ACC/AHA Task Force on Practice Guidelines expert panel that developed the cholesterol recommendations, he did not do so as an official representative of the AAFP. The Academy and other primary care organizations were not invited to participate in the guideline development process after the National Heart, Lung and Blood Institute (NHLBI) handed that specific task over to the specialty societies earlier this year.
Moreover, Campos-Outcalt said the ACC/AHA provided all four guidelines to the AAFP -- including several hundred pages of supporting evidence for each one -- with only a limited amount of time for review before publication. CHPS currently is reviewing the guidelines.
"The Academy will assess this cholesterol guideline, along with all of the others, and make a decision as to whether we can endorse or not," Campos-Outcalt told AAFP News Now. That said, he added, "(the expert panel) did a lot of things better than last time. They performed a much more comprehensive and rigorous assessment than in 2003, but I think it will take at least a couple of months to get through this."
Path to Simpler Management
McBride said he thinks the changes will reduce the complexity of therapy at his own Madison, Wis.-based practice, noting that the panel updated the risk assessment tool to be more contemporary.
"The evidence strongly supports not only the use of risk assessment for primary prevention, but that the level of (initiation of) treatment for primary prevention is a 10-year risk assessment of 7.5 percent, which will make treatment for high-risk individuals in primary prevention simpler," said McBride. "We won't have to constantly use follow-up cholesterol measures for LDL treatment targets."
McBride took exception to concerns voiced in the popular press that the risk-reduction threshold is too severe and will result in too many people being started on statin therapy.
"I think a lot of the arithmetic that's been done in the popular press is wrong, because this (recommendation) is, in fact, putting more appropriate people on treatment and making sure that those who are not appropriate for treatment don't get put on medication," McBride said. "There are a lot more people at risk today than there were 10 years ago because of obesity and other age-related risk factors. There are more people with hypertension and more people with metabolic syndrome today because of changes in our population.
"Family physicians are well aware of those population changes," he said. "This guideline is all about putting the appropriate people on treatment."
The evidence for setting the new treatment threshold was clear, said McBride.
"The cut point was previously set at 10 percent … and we dropped it based on very good evidence that there was a strong benefit to statin treatment for a person with a 7.5 percent 10-year risk, because we also looked at lifetime risk," he said. "I also want to point out to family physicians that this (cut point/recommendation) is true for both men and women, basing the guideline on risk, not gender."
Furthermore, said McBride, the data used to create the guideline also indicate that it is the overall management of cholesterol -- regardless of blood cholesterol levels attained -- that resulted in strong evidence of reductions in heart disease and associated mortality.
"No clinical trial tested whether treating to a specific LDL level made a difference," he said. "(Researchers) used specific doses of cholesterol medicines, so the new guidelines reflect that."
Note of Caution
Campos-Outcalt said that although it's impossible to digest the new cholesterol guideline in a single reading, he does have some concerns.
"I count 46 total recommendations, 20 of which are graded 'E,' meaning they are based on expert opinion," Campos-Outcalt said. "So I do have to raise some questions when nearly half of your recommendations are based on expert opinion.
"This guideline also has some recommendations in it that rest upon evidence presented in the other guidelines that were just released. So, you basically have to assess all of them at once, which is a bit unusual."
AAFP EVP Douglas Henley, M.D., said the Academy has expressed its concern to the NHLBI that it wasn't given the opportunity to serve as a full and equal partner in the development of the guidelines.
"The reason physicians from a wide range of specialties typically work together on projects like this is to ensure special interests don't interfere with good science," Henley explained. "When you have organizations representing one specialty develop and release these kinds of guidelines, credibility can become an issue."
That concern notwithstanding, Campos-Outcalt said his own initial impression is that the expert panel largely followed the Institute of Medicine standards the AAFP uses to develop its own recommendations and, in the process, improved on the 2003 version of the cholesterol guideline.
"I think the lesson here is that if you don't base your (original) guidelines on good, solid evidence, they are going to change drastically (from one version to another)," he said. "I think it is fair for people to ask, 'Why did you make those recommendations the last time around?' Sometimes it is better to say nothing than to guess, because these 'revolving guidelines' can cause a lot of confusion."
According to CHPS Chair Alan Schwartzstein, M.D., the commission should make its recommendations on the ACC/AHA guidelines to the AAFP Board of Directors in the first quarter of 2014.