Comparison between zofenopril and ramipril in combination with acetylsalicylic acid in patients with left ventricular systolic dysfunction after acute myocardial infarction: results of a randomized, double-blind, parallel-group, multicenter, european study (smile-4) Full Text
Clinical Cardiology, 06/18/2012
Borghi C et al. – In patients with left ventricular dysfunction (LVD) following acute myocardial infarction (AMI), the efficacy of zofenopril associated with acetylsalicylic acid (ASA) was superior to that of ramipril plus ASA, indicating some important clinical implications for the future use of angiotensin–converting enzyme inhibitors (ACEIs) in patients with LVD or overt heart failure.Methods
- This phase IIIb, randomized, double–blind, parallel–group, multicenter, European study.
- Compared the safety and efficacy of zofenopril (60 mg/day) and ramipril (10 mg/day) plus ASA (100 mg/day), in 771 patients with LVD (clinical signs of heart failure or a left ventricular ejection fraction <45%) following acute myocardial infarction (AMI).
- The primary study end point was 1–year combined occurrence of death or hospitalization for cardiovascular causes.
- In the intention–to–treat population, the primary outcome was significantly reduced by zofenopril (n = 365) vs ramipril (n = 351) (odds ratio [OR]: 0.70, and 95% confidence interval [CI]: 0.51–0.96; P = 0.028) as a result of a decrease in cardiovascular hospitalization (OR: 0.64,95% CI: 0.46–0.88; P = 0.006).
- Mortality rate was not significantly different between the 2 treatments (OR: 1.51, 95% CI: 0.70–3.27; P = 0.293).
- Blood pressure values did not significantly change during the 1–year follow–up.
- N–terminal pro–brain natriuretic peptide levels were progressively reduced during the study, with no statistically significant between–treatment differences.
- Proportion of patients with deterioration of renal function during the study was similar between the 2 groups.
- Drug safety profile was comparable between treatments.