Clinical- and cost-effectiveness of LDL particle-guided statin therapy: a simulation study

We used the Archimedes Model, a mathematical simulation model (Model) to estimate the clinical- and cost-effectiveness of using LDL particle concentration (LDL-P) as an adjunct or alternative to LDL cholesterol (LDL-C) to guide statin therapy. LDL-P by NMR has been shown to be a better measure of cardiovascular disease (CVD) risk than LDL-C, and may therefore be a better gauge of the need for and response to statin treatment. Using the Model, we conducted a virtual clinical trial comparing the use of LDL-C alone, LDL-P alone, and LDL-C and LDL-P together to guide treatment in the general adult population, and in high-risk, dyslipidemic subpopulations. In the general population, the 5-year major adverse cardiovascular event (MACE) relative risk reduction (RRR) of LDL-P alone compared to the control arm (LDL-C alone) was 5.0% (95% CI, 4.7-5.3; p < .0001); using both LDL-C and LDL-P (dual markers) led to 3.0% RRR compared to the control arm (95% CI, 2.8-3.3; p < .0001). For individuals with diabetes, the RRR was 7.3% (95% CI, 6.4-8.2; p < .0001) for LDL-P alone and 6.9% for dual markers (95% CI, 6.1-7.8; both, p < .0001). In the general population, the costs per quality-adjusted life year (QALY) associated with the use of LDL-P alone were $76,052 at 5 years and $8913 at 20 years and $142,825 at 5 years and $25,505 at 20 years with the use of both markers. In high-risk subpopulations, the use of LDL-P alone was cost-saving at 5 years; whereas the cost per QALY for the use of both markers was $14,250 at 5 years and $859 at 20 years for high-risk dyslipidemics, $19,192 at 5 years and $649 at 20 years for diabetics, and $9030 at 5 years and $7268 at 20 years for patients with prior CHD. In conclusion, the model estimates that using LDL-P to guide statin therapy may reduce the risk of CVD events to a greater extent than does the use of LDL-C alone and maybe cost-effective or cost-saving for high-risk patients.