COST EFFECTIVENESS OF ZOFENOPRIL IN THE TREATMENT OF PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION AFTER ACUTE MYOCARDIAL INFARCTION: A POST-HOC ANALYSIS OF THE SMILE-4 STUDY

Background: in the Survival of Myocardial Infarction Long-term Evaluation 4 Study (SMILE-4) zofenopril associated with ASA was superior to ramipril 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 zofenopril compared to ramipril. Methods: a total of 771 patients with LVD and AMI were randomized double-blind to zofenopril 60 mg/day (n=389) or ramipril 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 National Health Service databases of the European countries participating into the study. The incremental cost-effectiveness ratio (ICER) was used to quantify the cost per event prevented with zofenopril vs. ramipril. Results: zofenopril 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 zofenopril was 13 less than with ramipril. The cost of drug therapies was higher with zofenopril (328.78 Euros per patient per year, n=365) than with ramipril (165.12 Euros per patient per year, n=351). The cost related to the occurrence of major cardiovascular events requiring hospitalization, averaged 4983.64 Euros for zofenopril and 4850.01 Euros for ramipril. The ICER of zofenopril vs. ramipril was 2125.45 Euros per event prevented (worst- and best-case scenario in the sensitivity analysis: 3590.09 and 3243.96 Euros, respectively). Conclusions: zofenopril is a viable and cost-effective treatment for managing patients with LVD after AMI.