CHICAGO – The latest cholesterol management guideline for U.S. practice has a core treatment principal that propels the field from its long-held focus on “know your cholesterol number,” that then became “know your risk” with the 2013 guideline, to what is now “personalize your risk.”
“The new guideline put special focus not just on risk, but on risk assessment that uses ‘enhancing factors’ to help patients understand their risk in a personal way and decide whether statin treatment is right for them” Neil J. Stone, MD, said at the American Heart Association scientific sessions.
Other novel features of the 2018 edition of the cholesterol management guideline included: specification of the role for two types of drugs other than statins – ezetimibe and PCSK9 inhibitors (including mention of the cost-value consideration when prescribing an expensive PCSK9 inhibitor); inclusion of coronary artery calcium (CAC) score assessment for patients with intermediate risk who are unsure whether statin treatment is right for them; and acknowledgment that nonfasting measurement of blood cholesterol levels is fine for most screening circumstances.
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Dr. Neil J. Stone
“Nonfasting is okay for many situations,” said Dr. Stone, a professor of medicine at Northwestern University here, and vice-chair of the writing panel for the guidelines, released by the American College of Cardiology, the American Heart Association, and 10 additional endorsing societies (J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003)
But among the changes in the 2018 guideline that distinguish it from the preceding, 2013 version (Circulation. 2014 June 24;129[25, suppl 2]:S1-S45), the expanded approach to risk assessment in the primary-prevention setting stood out as the biggest shift.
“In 2013 we said calculate a person’s risk” for atherosclerotic cardiovascular disease. “Now that is much more fleshed out,” said Donald M. Lloyd-Jones, MD, a member of the guideline-writing group who helped develop the risk assessment tools used by the guideline.*
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Dr. Donald M. Lloyd-Jones
“The risk equations now are the same as we introduced in 2013,” he noted, and research done by Dr. Lloyd-Jones and others since that introduction showed that the “pooled cohort equations” are “well calibrated” for estimating a person’s 10-year risk for a cardiovascular event, especially at a risk level around 7.5%, which serves as the threshold for identifying a person with enough risk to warrant statin treatment. “But there are subgroups where the risk calculator clearly over- or under-estimates risk,” and that’s why the new guideline introduced the concept of risk enhancers--additional features not included in the basic risk calculation that enhance risk: family history; metabolic syndrome; chronic kidney disease; chronic inflammatory diseases such as psoriasis, rheumatoid arthritis, or HIV infection; a history of premature menopause or preeclampsia, certain ethnicity, or high levels of Lp(a) or apolipoprotein B.
“We didn’t need new risk scores; we needed to understand how to use the scores better, and the new guideline goes a long way toward helping clinicians do that,” Dr. Lloyd-Jones said in an interview.
Another aspect of this new, more nuanced approach to individualized risk assessment is the introduction of the CAC score as a possible tie breaker when a person who is otherwise a candidate for statin treatment for primary prevention is unsure about committing to possibly decades of daily statin treatment.
The guideline does not endorse obtaining a person’s CAC score for everyone as screening, stressed Dr. Stone, but this score, obtained by noncontrast CT with a radiation dose of about 1 mSv – comparable to a mammography exam, received a IIa rating” – is reasonable” for helping patients decide. Dr. Stone and others cited the importance of a CAC score of zero for patients on the fence for statin treatment as a strong indicator for many people that they can safely defer treatment.
As a result of this new endorsement for selectively obtaining CAC scores, “I think the number of tests will increase, probably fairly substantially,” said Dr. Lloyd-Jones, professor and chair of preventive medicine at Northwestern University here. He also expressed hope that this acknowledgment of an evidenced-based role for selected CAC score imaging may prompt health insurers to start coving this expense, something they don’t now do. Patients generally pay out-of-pocket from $50 to $300 for CAC score imaging. “I hope they will start paying for this,” Dr. Lloyd-Jones said.
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Dr. Mark A. Hlatky
The guidelines also deal, at least in passing, with another financial issue that has loomed large for cholesterol treatment, the role of the notoriously expensive PCSK9 inhibitors, alirocumab (Praluent) and evolocumab (Repatha). For secondary prevention patients or for patients with familial hypercholesterolemia who do not reach their LDL cholesterol goal on statin treatment alone, the guideline recommended treatment first with generic ezetimibe. If the goal remains elusive, the next step is prescribing a PCSK9 inhibitor. The guideline also noted the poor cost-benefit ratio for the PCSK9 inhibitors at the U.S. list prices that existed in mid-2018, about $14,000 a year.
The guideline writers noted that this is one of the first times that cost considerations found their way into cardiology guidelines. Clinicians “need to be attuned to prescribing PCSK9 inhibitors only in those settings when it provides good value to patients,” explained Mark A. Hlatky, MD, a professor of medicine, cardiologist, and health policy specialist at Stanford (Calif.) University. The guideline “focuses on patient selection for PCSK9 inhibitors, limiting it to patients who get the most benefit,” said Dr. Hlatky, another member of the writing panel.
Although 10 medical groups joined the American College of Cardiology and American Heart Association in endorsing the guideline, conspicuously absent were the two largest U.S. societies representing primary care physicians, the American College of Physicians and American Academy of Family Practitioners. The guideline’s organizers invited both these societies to participate in the process and they declined, said Sidney C. Smith, Jr., MD, a member of the guideline committee.
Dr. Stone and Dr. Lloyd-Jones had no financial disclosures. The writing committee members’ disclosures can be found at jaccjacc.acc.org/Clinical_Document/Cholesterol_GL_Au_Comp_RWI.pdf.
*Correction, 11/13/18: An earlier version of this article misstated the name of Dr. Donald M. Lloyd-Jones.
SOURCE: AHA 2018 and Grundy S et al. J Am Coll Cardiol. 2018;doi:10.1016/j.jacc.2018.11.003.