title: Cost-effectiveness of zofenopril in patients with left ventricular systolic dysfunction after acute myocardial infarction: a post hoc analysis of SMILE-4.
abstract: BACKGROUND
  In SMILE-4 (the Survival of Myocardial Infarction Long-term Evaluation 4 study), zofenopril + acetylsalicylic acid (ASA) was superior to ramipril + ASA in reducing the occurrence of major cardiovascular events in patients with left ventricular dysfunction following acute myocardial infarction. The present post hoc analysis was performed to compare the cost-effectiveness of zofenopril and ramipril.
  
  
  METHODS
  In total, 771 patients with left ventricular dysfunction and acute myocardial infarction were randomized in a double-blind manner to receive zofenopril 60 mg/day (n = 389) or ramipril 10 mg/day (n = 382) + ASA 100 mg/day and were followed up for one year. The primary study endpoint was the one-year combined occurrence of death or hospitalization for cardiovascular causes. The economic analysis was based on 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 in the study. The incremental cost-effectiveness ratio was used to quantify the cost per event prevented with zofenopril versus ramipril.
  
  
  RESULTS
  Zofenopril significantly (P = 0.028) reduced the risk of the primary study endpoint by 30% as compared with ramipril (95% confidence interval, 4%-49%). 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 incremental cost-effectiveness ratio for zofenopril versus ramipril was 2125.45 Euros per event prevented (worst and best case scenario in the sensitivity analysis was 3590.09 and 3243.96 Euros, respectively).
  
  
  CONCLUSIONS
  Zofenopril is a viable and cost-effective treatment for managing patients with left ventricular dysfunction after acute myocardial infarction.
authors.affiliation: Unit of Internal Medicine, Policlinico S Orsola, University of Bologna, Bologna, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Borghi
authors.forename: Ettore
authors.initials: E
authors.lastname: Ambrosioni
authors.forename: Stefano
authors.initials: S
authors.lastname: Omboni
authors.forename: Arrigo Fg
authors.initials: AF
authors.lastname: Cicero
authors.forename: Stefano
authors.initials: S
authors.lastname: Bacchelli
authors.forename: Daniela Degli
authors.initials: DD
authors.lastname: Esposti
authors.forename: Salvatore
authors.initials: S
authors.lastname: Novo
authors.forename: Dragos
authors.initials: D
authors.lastname: Vinereanu
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ambrosio
authors.forename: Giorgio
authors.initials: G
authors.lastname: Reggiardo
authors.forename: Dario
authors.initials: D
authors.lastname: Zava
keywords: acetylsalicylic acid; acute myocardial infarction; angiotensin-converting enzyme inhibitors; cost-effectiveness; left ventricular dysfunction; ramipril; zofenopril