The American College of Cardiology today released expert consensus guidance regarding the use of non-statin therapies to lower cholesterol (fat molecule) in high-risk patients.
The purpose of the document, 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol (fat molecule) Lowering in the Management of Atherosclerotic Cardiovascular Disease (heart disease) Risk, is to provide practical guidance for clinicians and patients in situations not covered by the evidence-based 2013 ACC/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults.
Consistent with the 2013 Guideline, this new document recommends looking first at lifestyle issues, including diet, exercise and smoking, followed by statin therapy.
“Lifestyle modification remains a critical component of cardiovascular disease (heart disease) risk reduction, both prior to and in concert with the use of cholesterol-lowering drug therapies,” said Pamela B. Morris, MD, FACC, FNLA, director of the Seinsheimer Cardiovascular Health Program at the Medical University of South Carolina, chair of the ACC Prevention of Cardiovascular Disease council, secretary of the southeast chapter of the National Lipid (fat molecule) Association, and vice-chair of the writing committee. “This includes adhering to a heart healthy diet, regular exercise habits, avoidance of tobacco products, and maintenance of a healthy weight. Adherence to lifestyle modification should be regularly assessed at the time of initiation or modification of statin therapy and during monitoring of ongoing therapy.”
Since the publication of the 2013 cholesterol guideline, the US Food and Drug Administration has approved for certain patient groups two monoclonal antibodies, proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors, which have been shown to dramatically reduce low-density lipoprotein cholesterol levels over and above statin therapy. Additionally, recent publication of the HPS2-THRIVE (examining niacin) and IMPROVE-IT (examining ezetimibe) trials has provided new evidence about the addition of non-statin therapies to statins. The writing committee supports consideration of adding ezetimibe 10 mg daily as the first non-statin agent for many higher-risk patient groups, based upon the benefits in terms of atherosclerotic cardiovascular disease outcomes and demonstrated safety of ezetimibe in patients with acute coronary syndrome (heart attack or pre-heart attack) treated with ezetimibe-simvastatin versus simvastatin monotherapy. However, they found that there are no clear indications for the routine use of niacin preparations as additional non-statin therapies, and therefore, do not recommend niacin for the situations discussed in the document.
“While evidence-based statin therapy remains the first-line standard of care for patients at risk for atherosclerotic cardiovascular disease, clinicians and patients may seek firmer and more specific guidance on adequacy of statin therapy and whether or when to use non-statin therapies if response to statins is deemed inadequate,” said Donald M. Lloyd-Jones, MD, ScM, FACC, chair of the department of preventative medicine and Eileen M. Foell professor of heart research at Northwestern University Feinberg School of Medicine and chair of the writing committee for the document. “Before initiation of combination therapy, it is imperative for clinicians and patients to engage in a discussion that includes the potential for net benefit, including absolute atherosclerotic cardiovascular disease risk-reduction benefits and potential harms, prescribing considerations and patient preferences for treatment.”
The algorithms in this expert consensus decision pathway for consideration of the addition of non-statin therapies to statin therapy begin with the assumption that the patient is in one of the four evidence-based statin benefit groups identified in the 2013 ACC/AHA cholesterol guideline: Patients with clinical atherosclerotic cardiovascular disease; patients with LDL-C ≥190 mg/dL, not due to secondary causes; patients aged 40-75 years with diabetes mellitus and LDL-C 70-189 mg/dL; patients aged 40-75 years with no diabetes but with LDL-C 70-189 mg/dL and predicted 10-year atherosclerotic cardiovascular disease risk ≥7.5%. For other groups of patients, care should be individualized. Each algorithm provides a suggested clinical workflow for consideration of the addition of non-statin therapies to evidence-based statin therapy.
Critical to the decision process for use of additional non-statin therapies in selected high-risk patients is the definition of thresholds of LDL-C, in terms of percentage reduction and absolute values, for consideration of net atherosclerotic cardiovascular disease risk-reduction benefit. The writing committee emphasizes that these are not firm triggers for adding medication but factors that may be considered within the broader context of an individual patient’s clinical situation.
Additional considerations in the initiation of non-statin therapies include the extent of available scientific evidence for safety and tolerability, potential for drug-drug interactions, efficacy of additional LDL-C lowering in ASCVD event reduction, cost, convenience and medication storage, pill burden, route of administration, potential to jeopardize adherence to evidence-based therapies, and importantly, patient preferences, according to the document.
The full document will post online today in the Journal of the American College of Cardiology and will be presented on April 2, 2016, at 6:00 p.m. CT/7:00 p.m. ET in Grand Ballroom S100bc at the American College of Cardiology’s 65th Annual Scientific Session in Chicago. The meeting runs April 2-4.
The American College of Cardiology is a 52,000-member medical society that is the professional home for the entire cardiovascular (heart and blood vessels) care team. The mission of the College is to transform cardiovascular care and to improve heart health. The ACC leads in the formation of health policy, standards and guidelines. The College operates national registries to measure and improve care, provides professional medical education, disseminates cardiovascular research and bestows credentials upon cardiovascular specialists who meet stringent qualifications. For more information, visit acc.org.
The ACC’s Annual Scientific Session, which in 2016 will be April 2-4 in Chicago, brings together cardiologists (heart doctor) and cardiovascular specialists from around the world to share the newest discoveries in treatment and prevention. Follow @ACCMediaCenter and #ACC16 for the latest news from the meeting.