Determining When to Add Nonstatin Therapy: A Quantitative Approach.
BACKGROUND Costs and uncertainty about the benefits of nonstatin therapies limit their use. OBJECTIVES The authors sought to identify patients who might benefit from the addition of a nonstatin to background statin therapy. METHODS We performed systematic reviews of subgroup analyses from randomized trials and observational studies with statin treated participants to determine estimated 10 year absolute risk of atherosclerotic cardiovascular disease (ASCVD) and to define high risk and very high risk patients. We used the relative risk reductions for the addition of a nonstatin to lower low density lipoprotein (LDL C) used to determine the number needed to treat (NNT) to prevent 1 ASCVD event over 5 years for each patient group and to allow comparisons with 5 year cost analyses. RESULTS The 10 year ASCVD risk is at least 30% (very high risk) for statin treated participants with clinical ASCVD and comorbidities, and 20% to 29% (high risk) for those with ASCVD without comorbidities or who have heterozygous familial hypercholesterolemia. Adding ezetimibe to reduce low density LDL C by 20% would provide a 5 year NNT =50 for very high risk patients with LDL C =130 mg/dl or for high risk patients with LDL C =190 mg/dl, and an NNT =30 for very high risk patients with LDL C =160 mg/dl. Adding a PCSK9 monoclonal antibody to lower LDL C by at least 50% would provide an NNT =50 for very high risk and high risk patients with LDL C =70 mg/dl, and an NNT =30 for very high risk and high risk patients with an LDL C =130 mg/dl. CONCLUSIONS Adding ezetimibe or PCSK9 monoclonal antibodies to maximally tolerated statin therapy may be cost effective in very high risk and high risk patients, depending on baseline LDL C levels.
Journal of the American College of Cardiology