Effects of early treatment with zofenopril in patients with myocardial infarction and metabolic syndrome: the SMILE Study.

OBJECTIVE: To evaluate the clinical efficacy of the early administration of zofenopril in a group of patients with and without metabolic syndrome (MS+ and MS-) and anterior myocardial infarction enrolled in the Survival of Myocardial Infarction Long-Term Evaluation (SMILE) Study. METHODS: Patients were randomized double-blind to zofenopril (n=719) or placebo (n=699) for 6 weeks. The primary end point was the effect of treatment on the 6-week combined occurrence of death and severe congestive heart failure. The secondary end point was the 1-year mortality rate. RESULTS: Of the 1418 patients included in this post-hoc analysis, 686 (48.3%) had MS. After 6 weeks of treatment zofenopril significantly reduced the incidence of all-cause death and severe congestive failure (risk reduction: 69%, 95% CI: 7-78; 2p=0.002) in MS+ patients. This was the case for 1-year mortality, too (29%, 95% CI: 4-41; 2p=0.048). Zofenopril was effective also in MS- patients but the amount of relative risk reduction was less than in MS+ for both the primary (-11%; 2p=0.61) and secondary endpoint (-19%; 2p=0.025). CONCLUSIONS: Results of this post-hoc analysis of the SMILE Study demonstrate the striking benefit of early administration of zofenopril in MS+ patients with acute anterior myocardial infarction.