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Special consideration of risk factors and new therapies should make the patient-doctor discussion more granular for those at risk for atherosclerotic cardiovascular disease, according to updated national cholesterol guidelines.

And PCSK9 inhibitors are now recommended in secondary prevention for some patients, the American Heart Association (AHA) and American College of Cardiology (ACC) said in their released at the annual AHA conference.

An important update over the 2013 guidelines is the emphasis on care providers giving special consideration to those at very high risk, said Neil Stone, MD, of Northwestern Medicine in Chicago and vice-chair of the guideline writing committee.

If a very high risk patient has LDL cholesterol 70 mg/dL or higher despite taking as maximally-tolerated statins, the evidence points to ezetimibe (Zetia) first, then if that fails, advancing to a PCSK9 inhibitor. "Very high risk" is defined as a person having a history of multiple major atherosclerotic cardiovascular disease events or one such major event plus multiple high-risk conditions.

Among other groups, patients ages 30 to 75 with heterozygous familial hypercholesterolemia and LDL cholesterol 100 mg/dL or higher already on the other two therapies may also be candidates for PCSK9 inhibitors.

The guidelines also addressed cost: PCSK9 inhibitors were deemed generally of low value for secondary prevention, at more than $150,000 per quality-adjusted life-year. For familial hypercholesterolemia patients without evidence of clinical heart disease who are on statins and ezetimibe, the PCSK9 inhibitors are of "uncertain value."

However, these were based on cost estimates from mid-2018. In October, Amgen revealed that it would reduce the price of evolocumab (Repatha) by 60%, to $5,850 per year. A company representative said it was pleased with the guidelines and the recognition that lower LDL is better.

Other changes to the cholesterol guideline are that fasting and non-fasting blood samples can both be used for lipid screening.

Moreover, "we endorse and expand the scope of the risk discussion," said Stone. In the new guidelines, he and his colleagues introduced risk-enhancing factors that help personalize primary prevention strategies and recommended the use of the coronary artery calcium score in selected adults when a risk decision is uncertain.

The pooled cohort equations for risk estimation are the still starting point for the risk discussion -- the coronary artery calcium score is the "tie breaker" that can be used for select individuals with intermediate 10-year risk, Stone said.

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