The new 2018 ACC/AHA Guideline on the Management of Blood Cholesterol allows for more personalized care for patients compared to its 2013 predecessor. Among the biggest changes: more detailed risk assessments and new cholesterol-lowering drug options for people at the highest risk for cardiovascular disease. The guidelines were released Nov. 10 at AHA 2018 in Chicago, IL, and simultaneously published in the Journal of the American College of Cardiology and Circulation.
“High cholesterol treatment is not one size fits all, and this guideline strongly establishes the importance of personalized care,” said ACC President C. Michael Valentine, MD, FACC. “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.”
In addition to traditional risk factors such as smoking, high blood pressure and high blood sugar, the new guideline adds factors like family history and ethnicity, as well as certain health conditions such as metabolic syndrome, chronic kidney disease, chronic inflammatory conditions, premature menopause or pre-eclampsia and high lipid biomarkers, to help health care providers better determine individualized risk and treatment options. They also recommend coronary artery calcium scores as a second-line decision-making tool with patients when determining whether to use statins.
Recognizing the cumulative effect of high cholesterol over the full lifespan, identifying and treating it early can help reduce the lifetime risk for cardiovascular disease. The new guideline suggests elective cholesterol screening is appropriate for children as young as two who have a family history of heart disease or high cholesterol. In most children, an initial screening test can be considered between the ages of nine and 11 and then again between 17 and 21. Because of a lack of sufficient evidence in young adults, there are no specific recommendations for that age group. However, it is essential that they adhere to a healthy lifestyle, be aware of the risk of high cholesterol levels and get treatment as appropriate at all ages to reduce the lifetime risk of heart disease and stroke.
“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,” said AHA President Ivor Benjamin, MD, FACC.
The guideline also sets out very specific recommendations for clinicians to discuss options with patients in the newly defined “very high risk of ASCVD” category who still have LDL-C above 70 mg/dL after maximizing statin therapy. It recommends considering other non-statin drugs, including ezetimibe and PCSK9 inhibitors. For the first time, the new guideline also includes a Value Statement that underscores the need for clinicians and patients to factor in the cost of drugs in determining the most appropriate treatment rates. The guideline gives PCSK9 inhibitors a low-cost value for patients at very high risk of ASCVD and uncertain value for patients with familial hypercholesterolemia compared to good cost value based on pricing through mid-2018. However, it remains to be seen if recent reductions in pricing for some PCSK9 inhibitors and results from clinical outcomes results from studies like ODYSSEY OUTCOMES could alter the value equation down the road.
“The ACC has long recognized that the cost of PCSK9s have made patient access an issue. We are committed to helping physicians with access to care issues, while also bringing together stakeholders, including payer, industry and clinician representatives, to talk about opportunities to move forward together,” Valentine adds. “Our goal is to make sure the highest risk patients have access to the care they need.”