The Performance Gap between Clinical Trials and Patient Treatment for Dyslipidemia: A Comprehensive Review

Cardiovascular disease is the primary cause of death in the US. Controlling dyslipidemia, particularly elevated low-density lipoprotein-cholesterol (LDL-C), is considered a primary strategy to reduce cardiovascular risk. HMG-CoA reductase inhibitors (statins) are the most effective agents available to lower LDL-C. Moreover, evidence from numerous prospective clinical trials has shown that statins reduce both cardiovascular disease morbidity and mortality in patients with dyslipidemia. Newer evidence has resulted in updated consensus guidelines that list reducing LDL-C values to a greater degree than has previously been recommended as therapeutic options for certain at-risk populations. Despite these conclusive benefits, most patients at risk for cardiovascular disease have LDL-C values that are above recommended goal values. Observational studies have identified several problems in managing dyslipidemia. These include infrequent screening for dyslipidemia by measuring fasting lipid panels, not prescribing statin therapy in high-risk individuals, incomplete monitoring in patients receiving statin therapy, and a general inability to attain recommended LDL-C goal values in patients receiving statin therapy. This gap between efficacy from clinical trials and treatment in clinical practice is particularly important to managed care organizations because statin therapy can reduce cardiovascular risk and may result in reduced overall healthcare costs. Many drug-based and system-based strategies can be implemented by managed care organizations to reduce this gap. Using high-potency statins, selecting appropriate initial statin doses based on the degree of LDL-C reduction that is required, and combination therapy (e.g. a statin with ezetimibe, bile acid sequestrants, niacin, or fibric acid derivatives) can result in greater LDL-C lowering than by simply using the lowest starting dose of any given statin. System-based models that utilize specific disease state management clinics, therapeutic intervention programs that target population-based improvements in LDL-C goal attainment, and judicious formulary management that includes therapeutic conversion initiatives have all been successfully implemented in managed care environments.