according to a summary by the American Association of Clinical Endocrinologists and American College of Endocrinology.
Achieving such a low LDL-cholesterol (LDL-C) level is possible with well-established medications such as a combination of simvastatin and ezetimibe and the newer, more clinically powerful agent PCSK9 inhibitors, Paul S. Jellinger, MD, chair of the guideline committee and professor of clinical medicine, University of Miami, said in an interview. The “extreme risk” category was derived largely from IMPROVE-IT and supporting meta-analyses.
The new category applies to patients with established atherosclerotic cardiovascular disease (ASCVD) who have any of the following risk factors:
• Progressive ASCVD including unstable angina after achieving an LDL-C level less than 70 mg/dL.
• Type 2 diabetes mellitus, chronic kidney disease stage 3 or 4, or heterozygous familial hypercholesterolemia.
• A history of premature ASCVD (before age 55 years in men, 65 years in women).
Heterozygous hypercholesterolemia is more common than many physicians realize, affecting as it does 1 in 250 people, Dr. Jellinger noted.
“Supporting evidence for the ‘extreme risk’ category with an LDL-C of less than 55 mg/dL was recently announced with the top line results from the FOURIER CVD outcome trial utilizing PCSK9-inhibitor therapy, which met both its primary and secondary endpoints,” he stressed.
PCSK9 inhibitors are extremely expensive, said Dr. Jellinger. “In my view, payers should not be denying patients who clearly meet the Food and Drug Administration approved indications for PCSK9 inhibitors and those within the extreme risk criteria. Yet, I have been made aware that 80% of insurance claims for PCSK9 inhibitors in these extremely high-risk and vulnerable patients are being denied.”
Inclusion in the updated AACE lipid management guidelines should strengthen PCSK9 inhibitors’ place among lipid-lowering drugs that are acceptable to insurance companies by making it clear that PCSK9 is appropriate and indicated for select patients, according to Dr. Jellinger.
Aside from creation of the extreme risk category, the AACE lipid guidelines discuss the available tools for making a global risk assessment of having a cardiac, vascular, or stroke event in the next 10 years, without favoring any one risk score. Among the systems discussed, with links, are the Framingham, MESA (Multi-Ethnic Study of Atherosclerosis), Reynolds, and United Kingdom Prospective Diabetes Study risk scores.
The guidelines provide separate approaches to management of people at various ages. Another change from the 2012 guidelines is the establishment of acceptable and worrisome LDL-C levels in children: Acceptable is a level under 100 mg/dL, borderline is 100-129 mg/dL, and high is LDL-C at or above 130 mg/dL.
The guidelines, which will be published in full in the April issue of Endocrine Practice, are based largely on numerous clinical trials and studies, and in the end produced 87 recommendations, of which 45 are Grade A, 18 are Grade B, 15 are Grade C, and 9 are Grade D.
These are the first guidelines on lipid management from AACE since 2012. The executive summary of the guidelines is available at www.aace.com.
Dr. Jellinger reported receiving speakers honoraria from Amgen, AstraZeneca, BI-Lilly, Merck, and Novo Nordisk.