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

Abstract

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.

Keywords:

• SMILE Study
• angiotensin converting enzyme inhibitor
• zofenopril
• myocardial infarction
• metabolic syndrome

Acknowledgements

Authors wish to thank Menarini group (Firenze, Italy) for the unconditioned support to the SMILE study group.

Disclosures

None of the authors has any conflicts of interest to disclose.