Guidance issued on nonstatin therapies for cholesterol lowering

An American College of Cardiology (ACC) task force issued guidance last week on the role of nonstatin therapies in lowering LDL cholesterol levels to manage risk for atherosclerotic cardiovascular disease.

The expert consensus decision pathway was a report of the ACC Task Force on Clinical Expert Consensus Documents and was endorsed by the National Lipid Association. The authors noted that the 2013 ACC/American Heart Association (AHA) Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults found limited evidence on use of nonstatin therapies and provided purposely broad guidance in this area to allow clinical discretion and consideration of individual patients' circumstances. Since then, additional research has since been published and the FDA has approved new cholesterol-lowering drugs. Because clinicians and patients might need more concrete guidance on adequacy of statin therapy and potential use of nonstatin therapies in case of inadequate response to statins, the authors wrote, the goal of this decision pathway was “to provide practical guidance for clinicians and patients in situations not covered by the 2013 ACC/AHA guideline” until new clinical guidelines on the topic are published.

The panel was asked to address the populations and situations in which nonstatin therapies should be considered and, if nonstatin therapies are to be added, which should be considered and in what order. Algorithms were developed for treatment of patients who were assumed to be in 1 of 4 groups:

1. 1. patients at least 21 years of age with clinical atherosclerotic cardiovascular disease who were taking a statin for secondary prevention;
2. 2. patients at least 21 years of age with LDL cholesterol levels ≥190 mg/dL not due to secondary causes who were on a statin for primary prevention;
3. 3. patients ages 40 to 75 years without atherosclerotic cardiovascular disease but with diabetes and LDL cholesterol levels 70 to 189 mg/dL who were on a statin for primary prevention; and
4. 4. patients ages 40 to 75 years without clinical atherosclerotic cardiovascular disease or diabetes but with LDL cholesterol levels 70 to 189 mg/dL and predicted 10-year atherosclerotic cardiovascular disease risk of ≥7.5% who were on a statin for primary prevention.

The panel assumed that patients were currently taking or had attempted to take a statin and that clinicians and patients were trying to determine whether additional therapy was needed to further reduce risk for atherosclerotic cardiovascular disease.

For all of these patients, clinicians should consider adherence and lifestyle; statin intolerance; control of other risk factors; clinician-patient discussion of potential benefits, potential harms, and patient preferences about adding nonstatin medications; percentage of LDL cholesterol reduction or absolute LDL cholesterol level achieved; and monitoring of response to therapy, adherence, and lifestyle, the panel noted.

Optional interventions to be considered, the panel said, are referral to a lipid specialist and registered dietitian, ezetimibe, bile acid sequestrants, and PCSK9 inhibitors. In addition, it said, lipid specialists may consider mipomersen, lomitapide, and LDL apheresis for patients who have familial hypercholesterolemia.

The guideline panel developed individual algorithms with detailed clinical workflows for different patient scenarios in the 4 groups above and also addressed special considerations for patients with symptomatic heart failure, patients receiving maintenance hemodialysis for end-stage renal disease, and patients who are pregnant or planning a pregnancy.

The full decision pathway was published April 1 by the Journal of the American College of Cardiology and is available free of charge online.