Objectives: The clinical efficacy of 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase inhibitor (statin) therapy in cardiovascular disease has been established in clinical trials. Nonetheless, it is unclear to whom and when statin treatment should be initiated for patients without cardiovascular disease with regard to overall absolute risk reduction of cardiovascular disease and the cost-effectiveness of long-term statin therapy. The objective of this study was to examine the cost-effectiveness of pravastatin 10 mg/d compared with no-drug therapy for primary prevention of coronary artery disease (CAD), using cardiac risk factors from risk predictions for CAD from Japanese cohort studies. Methods: A Markov transition model was used to evaluate the cost-effectiveness of pravastatin compared with no-drug therapy. The incidence of acute myocardial infarction was estimated by using risk predictions for CAD in Japan. A hypothetical population from 45 to 75 years old was examined by using the cardiac risk factors. Quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio over a lifetime horizon were estimated from a perspective of payers. Results: Incremental cost-effectiveness ratios of pravastatin therapy compared with no-drug therapy were 9,677,000 yen per QALY in 55-year-old men and 8,648,000 yen per QALY in 65-year-old men with diabetes mellitus, hypertension (grade II), and smoking as cardiac risk factors. Pravastatin therapy was not cost-effective compared with no-drug therapy in all subgroups evaluated. Conclusions: Using risk prediction for CAD based on a Japanese cohort with no history of cardiovascular events, the cost-effectiveness of pravastatin for primary prevention of CAD may not be cost-effective in populations at both low and high cardiac risk.
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