New ACC document covers lipid-lowering therapies introduced since 2018 guidelines
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The American College of Cardiology issued an expert consensus decision pathway to address new lipid-lowering agents and other developments since the release of the ACC/American Heart Association cholesterol guidelines in 2018.
“Since the publication of the 2018 AHA/ACC/multisociety cholesterol guidelines, several newer nonstatin agents have demonstrated LDL-C-lowering efficacy, have received FDA approval, and are commercially available for management of at-risk patients,” Donald M. Lloyd Jones, MD, ScM, FACC, FAHA, chair of the department of preventive medicine at Northwestern University Feinberg School of Medicine, immediate past president of the AHA and chair of the document’s writing committee, and colleagues wrote. “Additional data on higher-risk groups and outcomes in real-world samples have also allowed for refinement of prior recommendations. There are large, ongoing randomized controlled cardiovascular outcomes trials in progress for bempedoic acid and inclisiran. This has resulted in gaps in expert guidance regarding the role of available nonstatin therapies.”
Addressing knowledge gaps
The aim of the decision pathway, which was endorsed by the National Lipid Association, is to address knowledge gaps in LDL lowering to reduce risk for atherosclerotic CVD and to build on the evidence base from previous guidelines that is not covered by randomized controlled trial data, Lloyd-Jones and colleagues wrote.
“Specifically, the ACC convened this writing committee to answer the following questions regarding the use of nonstatin therapies:
- 1. In what patient populations should newer nonstatin therapies be considered?
- 2. In what situations should newer nonstatin therapies be considered; that is, when is the amount of LDL-C lowering (percent LDL-C reduction or LDL-C range achieved on therapy) less than anticipated, less than desired, or inadequate, and which treatment options should be considered in patients who are truly statin intolerant?
- 3. If newer nonstatin therapies are to be added, which therapies should be considered and in what order to maximize patient benefit and preference?” the authors wrote.
Appropriate nonstatin strategies
According to the document, the following nonstatin agents may be used to manage ASCVD risk via LDL lowering: ezetimibe, PCSK9 inhibitors, bempedoic acid (Nexletol, Esperion Therapeutics), bempedoic acid/ezetimibe (Nexlizet, Esperion Therapeutics), inclisiran (Leqvio, Novartis) and bile acid sequestrants.
Lloyd-Jones and colleagues also wrote that the following may be used to treat homozygous familial hypercholesterolemia under the care of a lipid specialist: evinacumab-dgnb (Evkeeza, Regeneron), lomitapide (Juxtapid, Amryt) and LDL apheresis.
The authors also noted the following topics should be included in a clinician-patient discussion of therapy: potential for additional ASCVD risk reduction beyond statin therapy, potential for clinically significant adverse events or drug-drug interactions from nonstatin therapies, cost considerations and patient preferences including perception of benefit, convenience of therapy, potential to jeopardize adherence to other evidence-based therapies, anticipated life expectancy, comorbidities and impact of therapy on quality of life.
“Recommendations attempt to provide practical guidance for clinicians and patients regarding the use of nonstatin therapies to further reduce ASCVD risk in situations not covered by the guideline until such time as the scientific evidence base expands and cardiovascular outcomes trials are completed with newer agents for ASCVD risk reduction,” Lloyd-Jones and colleagues wrote.
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