Recently, a new, investigational class of cholesterol-lowering medications has shown to be effective in lowering serum LDL cholesterol levels. Evolocumab and alirocumab are two medications under this class and their effectiveness has been investigated and demonstrated in three clinical trials presented at the Annual Meeting of the American College of Cardiology and published in the New England Journal of Medicine. While the goal LDL cholesterol level in the blood is below 100 mg/dL, some of the study participants experienced LDL reductions to 48 mg/dL and others below 25 mg/dL while on these monoclonal antibody agents. It is worth noting that as with other monoclonal antibody therapies, they must be given by injection every 2-4 weeks. Also, neurocognitive problems (e.g. confusion, lack of concentration) have been reported in study participants and the cost is expected to be around $7,000 annually. Research is currently being done to assess PCSK9 inhibitors’ prevention of heart attacks, strokes and other cardiovascular problems. What are your thoughts on potential use of PCSK9 inhibitors for cholesterol lowering? What are the risks of monoclonal antibody therapy? What cost justifications do you provide to your patients taking monoclonal antibody agents?
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