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New data prompt ACC updated statement on nonstatin therapy
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The American College of Cardiology has updated an expert consensus decision statement on the role of nonstatin therapies to lower LDL and manage atherosclerotic CVD risk to include recent data from FOURIER and SPIRE trials, which has been published in the Journal of the American College of Cardiology.
“Based on the important evidence of significant benefit in [CV] event reduction with the addition of evolocumab to maximally tolerated statin, with or without ezetimibe, and other new perspectives reviewed in the previous text, it was determined by the 2016 [expert consensus decision pathway] writing committee that a focused update on the original [expert consensus decision pathway] was needed to revise recommendations for high-risk patients with clinical [atherosclerotic] CVD with and without comorbidities who have a less-than-anticipated reduction in LDL or in whom additional LDL lowering is desirable,” Donald M. Lloyd-Jones, MD, FACC, chair of the department of medicine and Eileen M. Foell professor of heart research at Northwestern University Feinberg School of Medicine and chair of the writing committee, and colleagues wrote in the report.
FOURIER, SPIRE
The introduction has been updated with final results from the FOURIER, SPIRE-1 and SPIRE-2 trials to add more information on PCSK9 inhibitors evolocumab (Repatha, Amgen) and bococizumab (Pfizer), in addition to the existing evidence on niacin, ezetimibe and niacin/laropiprant.
Updates were made to various algorithms to determine whether statins should be used for primary or secondary prevention in patients aged at least 21 years with or without stable clinical atherosclerotic CVD (ASCVD) and with or without comorbidities, and primary prevention in patients aged 40 to 75 years without clinical ASCVD, diabetes, baseline LDL of 70 mg/dL to 189 mg/dL. Both LDL and non-HDL are now featured in the algorithms, as non-HDL thresholds were evaluated in the FOURIER, SPIRE-1, SPIRE-2 and the ongoing ODYSSEY Outcomes trials.
All patients aged at least 21 years with clinical ASCVD and baseline LDL between 70 mg/dL and 189 mg/dL may be considered for statin therapy for secondary prevention based on data from the FOURIER and IMPROVE-IT trials, which showed that lower LDL levels are safe and ideal in this patient population due to their increased risk for recurrent events.
In patients with clinical ASCVD, baseline LDL between 70 mg/dL and 189 mg/dL and comorbidities, ezetimibe or a PCSK9 inhibitor may be recommended if it has been decided to proceed from nonstatin to statin therapy, as data from the FOURIER trial showed that patients with ASCVD and additional risk factors had a significant reduction in endpoints such as MI, stroke and CV death.
Risk identification
To identify high risk in patients with clinical ASCVD and comorbidities, factors that have been used in the inclusion criteria in FOURIER have been implemented in this report, including those aged at least 65 years, prior nonhemorrhagic stroke or MI, symptomatic peripheral artery disease with prior stroke or MI, current daily smoking, residual CAD, history of non-MI-related coronary revascularization, metabolic syndrome and HDL less than 40 mg/dL for men and less than 50 mg/dL for women.
“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 [CV] outcomes trials are completed with new agents for ASCVD risk reduction,” Lloyd-Jones and colleagues wrote. – by Darlene Dobkowski
Disclosure: Lloyd-Jones reports no relevant financial disclosures. Please see the report for all other authors’ relevant financial disclosures.
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