Zofenopril is a cost-effective treatment for patients with left ventricular systolic dysfunction following acute myocardial infarction: a pharmacoeconomic analysis of the SMILE-4 study

Objective: The Survival of Myocardial Infarction Long-term Evaluation 4 Study (SMILE-4) showed the superiority of Zofenopril (Z) associated with Acetylsalicylic Acid (ASA) as respect to Ramipril (R) plus ASA in reducing the occurrence of major cardiovascular events, in patients with left ventricular dysfunction (LVD) following Acute Myocardial Infarction (AMI). The objective of this retrospective analysis was the evaluation of cost-effectiveness of Z compared to R. Methods: 771 patients with LVD and AMI were randomized, double-blind to Z 60 mg/day (n=389) or R 10 mg/day (n=382) plus ASA 100 mg/day and followed-up for 1 year. The primary study end-point was 1-year combined occurrence of death or hospitalization for cardiovascular causes. The economic analysis was based on the evaluation of cost of medications and hospitalizations and was applied to the intention-to-treat population (n=716). Cost data were drawn from the database of the Italian National Health Service. The Incremental Cost-Effectiveness Ratio (ICER) was used to quantify the cost per event prevented with Z vs. R. Results: Z significantly (p=0.028) reduced the risk of the primary study end-point by 30% as compared to ramipril (95% confidence interval: 49%, 4%). The number needed to treat to prevent a major cardiovascular event with Z was 13 less than with R. The cost of drug therapies was higher with Z (313.90 Euros per patient per year, n=365) than with R (160.60 Euros per patient per year, n=351). The cost related to the occurrence of major cardiovascular events requiring hospitalization, averaged 3195.47 Euros for Z and 3071.37 Euros for R. The ICER of Z vs. R was 1990.88 Euros per event prevented. Conclusions: Z is a viable and cost-effective treatment for managing patients with LVD after AMI.