title: Clinical- and cost-effectiveness of LDL particle-guided statin therapy: a simulation study.
abstract: 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.
authors: Archimedes, Inc., 123 Mission St, 11th floor, San Francisco, CA 94105, USA. Electronic address: henri.folse@archimedesmodel.com.
authors: Henry J
authors: HJ
authors: Folse
authors: Archimedes, Inc., 123 Mission St, 11th floor, San Francisco, CA 94105, USA. Electronic address: devesh.goswami@archimedesmodel.com.
authors: Devesh
authors: D
authors: Goswami
authors: Archimedes, Inc., 123 Mission St, 11th floor, San Francisco, CA 94105, USA. Electronic address: badri.rengarajan@archimedesmodel.com.
authors: Badri
authors: B
authors: Rengarajan
authors: Los Angeles Biomedical Research Institute, 1124 W Carson Street, Torrance, CA 90502, USA. Electronic address: mbudoff@labiomed.org.
authors: Matthew
authors: M
authors: Budoff
authors: University of North Carolina, 106 Dental Circle, Chapel Hill, NC 27599-7172, USA. Electronic address: rak6200@gmail.com.
authors: Richard
authors: R
authors: Kahn
mesh_terms: D000328:Adult; D000924:Anticholesteremic Agents / Q000191:economics / Q000627:therapeutic use*; D000069059:Atorvastatin; D002318:Cardiovascular Diseases / Q000191:economics / Q000401:mortality / Q000517:prevention & control; D015897:Comorbidity; D003198:Computer Simulation; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D003920:Diabetes Mellitus / Q000097:blood; D016527:Drug Costs; D057915:Drug Substitution; D050171:Dyslipidemias / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy* / Q000191:economics; D006538:Heptanoic Acids / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000191:economics / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy / Q000191:economics; D008019:Life Style; D008077:Lipoproteins, LDL / Q000097:blood*; D006278:Medicare / Q000191:economics; D008955:Models, Cardiovascular; D019906:Nuclear Magnetic Resonance, Biomolecular / Q000379:methods*; D011758:Pyrroles / Q000008:administration & dosage / Q000627:therapeutic use; D019057:Quality-Adjusted Life Years; D012306:Risk; D040242:Risk Reduction Behavior; D019821:Simvastatin / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome; D014481:United States
chemical_list: D000924:Anticholesteremic Agents; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008077:Lipoproteins, LDL; D011758:Pyrroles; D000069059:Atorvastatin; D019821:Simvastatin
keywords: Cholesterol; Hypercholesterolemia; Hyperlipoproteinemia; LDL particle; LDL-P; Lipoprotein; Statin