Cost effctiveness of zofenopril in patients with left ventricular systolic dysfunction afetr acute myocardial infarction: a post-hoc analysys of the smile-4 study.

OBJECTIVES: In the Survival of Myocardial Infarction Long-term Evaluation 4 Study (SMILE-4) zofenopril (Z) associated with acetylsalicylic acid (ASA) was superior 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 present post-hoc analysis was performed to evaluate cost-effectiveness of Z compared to R. METHODS: A total of 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 versus R. RESULTS: Z significantly (p=0.028) reduced the risk of the primary study endpoint 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 per patient per year, n=365) than with R (€160.60 per patient per year, n=351). The cost related to the occurrence of major cardiovascular events requiring hospitalization, averaged €3195.47 for Z and €3071.37 for R. The ICER of Z versus R was €1990.88 per event prevented. CONCLUSIONS: Z is a viable and costeffective treatment for managing patients with LVD after AMI.