November 28, 2018, 12:57 pm Chris Crawford – On Nov. 10, the American Heart Association (AHA) and the American College of Cardiology (ACC) released a new cholesterol guideline that includes, among other things, recommendations for more personalized risk assessments and new cholesterol-lowering drug options for people at the highest risk for cardiovascular disease (CVD).
The guideline, which nearly a dozen other health care groups have approved, was simultaneously published in the AHA's journal Circulation and the Journal of the American College of Cardiology.
"The updated guidelines reinforce the importance of healthy living, lifestyle modification and prevention. They build on the major shift we made in our 2013 cholesterol recommendations to focus on identifying and addressing lifetime risks for cardiovascular disease," said AHA President Ivor Benjamin, M.D., in a news release. "Having high cholesterol at any age increases that risk significantly. That's why it's so important that even at a young age, people follow a heart-heathy lifestyle and understand and maintain healthy cholesterol levels."
About one in three adults in the United States have high levels of LDL cholesterol, which contributes to fatty plaque buildups and narrowing of the arteries.
About 40 percent of American adults have a total cholesterol level of 200 mg/dL or higher; research shows that people with LDL cholesterol levels of 100 mg/dL or lower tend to have lower rates of heart disease and stroke, supporting a "lower is better" philosophy, the AHA/ACC said.
"High cholesterol treatment is not one-size-fits-all, and this guideline strongly establishes the importance of personalized care," said ACC President Michael Valentine, M.D., in the release. "Over the past five years, we've learned even more about new treatment options and which patients may benefit from them. By providing a treatment roadmap for clinicians, we are giving them the tools to help their patients understand and manage their risk and live longer, healthier lives."
This guideline updates the AHA/ACC's 2013 guideline on managing blood cholesterol, which the AAFP endorsed with qualifications
The AAFP's Commission on Health of the Public and Science is in the process of reviewing the updated guideline for possible endorsement, said Jennifer Frost, M.D., medical director for the Academy's Health of the Public and Science Division.
"The updated guideline puts a larger emphasis on lifestyle modification and shared decision-making, which family physicians will applaud," Frost told AAFP News. "The 2013 guideline introduced a major shift in how clinicians treat cholesterol, basing treatment on level of risk for cardiovascular disease rather than solely on cholesterol level."
The updated guideline continues to base treatment on risk, but also recommends non-statin therapy based on cholesterol level in patients at very high risk.
The recommendation for the addition of a non-statin is based on a systematic review of the evidence, Frost said. However, she added that the other recommendations in the guideline are based solely on individual studies and expert opinion, rather than an evaluation of the totality of evidence.
For additional context, Frost pointed to the U.S. Preventive Services Task Force's (USPSTF's) recommendation statement on statin therapy for the primary prevention of cardiovascular disease, which the Academy has endorsed.
A special report published as a companion to the cholesterol guideline offers a more detailed explanation of the use of quantitative risk assessment in primary prevention for cardiovascular disease.
The risk calculator introduced in the 2013 AHA/ACC guidelines remains a key tool that the new guideline highlights to help health care professionals identify patients' 10-year risk for CVD.
Using population-based formulas, the guideline recommends that physicians examine "risk-enhancing factors" and discuss them with patients to personalize their risk assessment, while also continuing to use traditional risk factors such as smoking, hypertension and high blood sugar to address under- or overestimated risk in some individuals.
Risk-enhancing factors include a positive family history; specific racial/ethnic backgrounds; and certain health conditions such as metabolic syndrome, chronic kidney disease, chronic inflammatory conditions, premature menopause or pre-eclampsia, and high lipid biomarkers.
In primary and secondary prevention, when high cholesterol can't be controlled by diet or exercise, statins are typically used to lower LDL cholesterol levels and CVD risk.
For patients who have already had a heart attack or stroke, are at highest risk for another event and whose LDL cholesterol levels are not adequately lowered by statin therapy, the guideline now recommends prescribing other cholesterol-lowering medications along with statins.
The guideline recommends a stepped approach that adds ezetimibe, available as a generic, to statin therapy for these patients. If that combination isn't successful, the groups suggest adding a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for patients at very high risk. This approach may also be considered as primary prevention for those with a genetic condition that causes very high LDL cholesterol.
"There have been concerns over the cost of PCSK9 inhibitors, and some insurance companies have been slow to cover them, so it's important to note that the economic value of these new medications may be substantial only for a very specific group of people for whom other treatments haven't worked," Benjamin said in the release.
"The (AHA) is bringing together stakeholders to discuss financial barriers to the care of heart disease and stroke," he added. "We have been heartened that drug makers have recently agreed to reduce the prices of PCSK9 inhibitors and are making arrangements with payers to ease the financial burden for patients who could benefit from the additional medication options."
Whether prescribing only lifestyle modifications or additional medication, the AHA/ACC recommended physicians assess adherence and effectiveness at four and 12 weeks with a fasting lipid test, then retest every three to 12 months based on need.
Another new recommendation in the guideline is taking coronary artery calcium (CAC) measurements for patients in some risk categories when their risk level isn't clear and treatment decisions are less certain.
A CAC score of zero usually correlates with a low risk for CVD and could mean those patients can forgo or at least delay cholesterol-lowering therapy if they are nonsmokers or don't have other high-risk behaviors or characteristics.
Considering the cumulative effect of high cholesterol during an entire lifespan, the AHA/ACC guideline noted that identifying and treating it early can help reduce the lifetime risk for CVD.
And although the USPSTF determined there is insufficient evidence to recommend screening cholesterol in children and adolescents, Frost said, the AHA/ACC suggests considering screening in children as young as age 2.
Children who have a positive screen may not need medication, but getting them started on healthy behaviors when they're young can make a difference in their lifetime risk.
"When high cholesterol is identified in children, that could also alert a doctor to test other family members who may not realize they have high cholesterol, because awareness and treatment can save lives," the groups said in the release.
Finally, the AHA/ACC said the new guideline offers more specific recommendations for certain age and ethnic groups, as well as for people with diabetes, which the authors said are all important factors that should be considered during any comprehensive and individualized physician-patient discussion on this topic.