The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) are ushering in a new era with the 2017 clinical practice guidelines for dyslipidemia management and atherosclerosis prevention. The guidelines, which have just been released online, include a new cardiovascular risk category.1 The guidelines also address a broader range of disease stages and call for more intense treatment and more aggressive intervention.
The executive summary contains 87 evidence-based recommendations that allow for nuance-based clinical decision-making. The clinical practice guidelines are intended to be a practical tool for endocrinologists to employ as a means of reducing the risks and consequences of dyslipidemia.
The new guidelines call for treating low-density lipoprotein cholesterol (LDL-C) levels in specific patient groups to lower goals than previously recommended. They also support the use of coronary artery calcium scores and inflammatory markers to help clinicians better stratify risk. Another notable feature is that the guidelines call for special consideration when it comes to patients with diabetes or familial hypercholesterolemia, women, and pediatric patients with dyslipidemia.
Extreme Risk Category
The Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Dyslipidemia and Prevention of Atherosclerosis were published by AACE in 2012. The 2017 update introduces a cardiovascular disease “Extreme Risk” category. The Extreme Risk category includes patients who have progressive cardiovascular disease, such as patients with unstable angina who have achieved a lowered LDL-C level and patients who have established cardiovascular disease accompanied by diabetes mellitus, chronic kidney disease (stages 3 or 4), or familial hypercholesterolemia.
The Extreme Risk category also includes men aged 55 years and younger and women aged 65 years and younger who have a history of premature cardiovascular disease.
“The Extreme Risk category with an LDL-C goal of <55 mg/dL is groundbreaking and represents the first time an organization has recommended this degree of LDL reduction. Much evidence has been pointing in this direction, but no recommendation until now had been made,” Paul Jellinger, MD, chairman of the AACE Lipids Guidelines Update Task Force Writing Committee, told Endocrinology Advisor.
He said data from the IMPROVE-IT trial (ClinicalTrials.gov identifier:NCT00202878) helped lead to some of the changes in the new guidelines. This trial showed that the addition of a nonstatin agent (ezetimibe) to a statin therapy lowered LDL-C by approximately 24%.2 The study also demonstrated that combining simvastatin and ezetimibe, which reduces the absorption of cholesterol from the gastrointestinal tract, resulted in a significantly lower risk for cardiovascular events than that seen with statin monotherapy.
Dr Jellinger, who is a past president of ACE, said the IMPROVE-IT trial confirmed what had been observed in previous clinical trials. “Prior outcome studies revealed that those patients treated with statins achieving the lowest LDL-C values had the best outcomes,” Dr Jellinger told Endocrinology Advisor.
“IMPROVE-IT was designed to test whether lowering LDL further beyond aggressive statin therapy with ezetimibe would improve outcomes. With statin plus ezetimibe, an average LDL-C of 53 mg/dL was achieved compared to the statin-alone group LDL-C of 69.9 mg/dL.”
He said there were also significant reductions in the atherosclerotic cardiovascular disease (ASCVD) end points in the statin-plus-ezetimibe group. Dr Jellinger said this “lower-is-better” benefit has been further demonstrated in several large meta-analyses.3, 4