Purpose: Using simulation modeling, this study compared the effects of statin therapy with atorvastatin and rosuvastatin on patients with low-density lipoprotein cholesterol (LDL-C) above goal, considering patterns of initial dose assignment and intensification in follow-up reflective of the US today.
Method: Two treatment scenarios were investigated, in which patients initiated atorvastatin (10, 20, 40, and 80 mg) or rosuvastatin (10, 20, and 40 mg), and then periodically intensified treatment, at rates determined from US pharmacy claims. The study used the Archimedes Model, a clinically detailed simulation model of human physiology, disease progression, and healthcare delivery. Simulated individuals (derived from NHANES 1999-2006) were aged 45 to 70 years and had LDL-C exceeding goal after discontinuing all previously prescribed lipid-lowering therapies. Treatments were modeled using data from published trials. Initial statin doses were conservatively assigned based on each individual’s LDL-C, their ATP III goal, and the expected treatment effect. During follow-up, patients not at goal intensified dose or maintained their therapy. Major cardiovascular events (MACE), comprising MI, stroke, or cardiovascular death, were tracked for 5 years for the overall and several high-risk subpopulations, including those with diagnosed diabetes and those with prior cardiovascular disease.
Result: At baseline, 56% of the overall study population (n=50,050) were men and had a mean age of 57.4 (SD: 6.9) years, mean LDL-C of 166.7 (41.6) mg/dl, mean systolic and diastolic blood pressure of 129.3 (17.0) and 75.1 (11.3) mmHg respectively, 58% with hypertension, 5% with prior MI, 4% with prior stroke, 26% with diagnosed diabetes, and 25% smokers. After 5 years, 84% of patients on rosuvastatin and 80% on atorvastatin attained their LDL-C goal. The 5-year incidence of MACE for rosuvastatin versus atorvastatin was 4.1% vs. 4.6% for the overall population, 4.5% vs. 4.8% for those with diabetes, and 12.8% vs. 13.8% for those with CVD; corresponding relative risks of MACE were 0.90 (95% CI: 0.88-0.92), 0.93 (0.89-0.97), and 0.93 (0.89-0.96); all p<0.05.
Conclusion: In this simulated study, treatment with rosuvastatin reduced the incidence of MACE more than atorvastatin over a 5-year period across all subpopulations considered. Further studies on early and appropriate statin use among patients with hyperlipidemia are warranted.
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