† The Vast Majority of High- and Very-High Risk Hypercholesterolemia Patients Never Reach below LDL-C Thresholds in the 2018 ACC/AHA Guidelines

Background/Synopsis Based on extensive clinical trial data demonstrating lower LDL-C reduces heart attacks, strokes, and need for interventional surgery, the 2018 Multidisciplinary Guideline on the Management of Blood Cholesterol calls for initiation and intensification of lipid-lowering therapies (LLT) if LDL-C exceeds defined thresholds in high and very high (H/VH) risk patients. Objective/Purpose Achievement of below-threshold LDL-C levels in H/VH risk patients was assessed using real-world data from the Family Heart Database (n=>324 million patients). Methods A subset of 38,110,734 guideline-defined, H/VH risk patients with sufficient diagnosis, procedure, medication, and lab data was analyzed. Patient histories were divided into contiguous episodes characterized by the LLT use (including none), prescription filling, and LDL-C level. Results Most H/VH risk patients (72%; n= 27,525,227) never achieved LDL-C below guideline thresholds. For those achieving periods below recommended LDL-C thresholds, mean duration was 159 days. Majority of HCPs (81%; n= 632,114) never prescribed combination LLT, though the guideline provides direction and rationale for doing so. Conclusions Despite effective and safe LLT, most H/VH patients remain above guideline-recommended LDL-C thresholds and those achieving persistent episodes below LDL-C thresholds do so for only brief durations. For the highest risk American patients, lack of prescribing combination LLT and low adherence to prescribed LLT fails to prevent future cardiovascular events. External Funding Yes Funding Sources The Family Heart Foundation is a 501c3 public charity research and advocacy organization that receives contributions and sponsorships from individuals, foundations, and pharmaceutical companies. This research was partially funded by Amgen, although it played no role in study design, conduct, interpretation or plans for publication. Based on extensive clinical trial data demonstrating lower LDL-C reduces heart attacks, strokes, and need for interventional surgery, the 2018 Multidisciplinary Guideline on the Management of Blood Cholesterol calls for initiation and intensification of lipid-lowering therapies (LLT) if LDL-C exceeds defined thresholds in high and very high (H/VH) risk patients. Achievement of below-threshold LDL-C levels in H/VH risk patients was assessed using real-world data from the Family Heart Database (n=>324 million patients). A subset of 38,110,734 guideline-defined, H/VH risk patients with sufficient diagnosis, procedure, medication, and lab data was analyzed. Patient histories were divided into contiguous episodes characterized by the LLT use (including none), prescription filling, and LDL-C level. Most H/VH risk patients (72%; n= 27,525,227) never achieved LDL-C below guideline thresholds. For those achieving periods below recommended LDL-C thresholds, mean duration was 159 days. Majority of HCPs (81%; n= 632,114) never prescribed combination LLT, though the guideline provides direction and rationale for doing so. Despite effective and safe LLT, most H/VH patients remain above guideline-recommended LDL-C thresholds and those achieving persistent episodes below LDL-C thresholds do so for only brief durations. For the highest risk American patients, lack of prescribing combination LLT and low adherence to prescribed LLT fails to prevent future cardiovascular events.