Efficacy and Safety of Zofenopril Versus Ramipril in the Treatment of Myocardial Infarction and Heart Failure: A Review of the Published and Unpublished Data of the Randomized Double-Blind SMILE-4 Stu...
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Abstract
Zofenopril is a lipophilic sulfhydryl group containing angiotensin converting enzyme ACE inhibitor characterized by wide tissue distribution long duration of action and pleiotropic effects on endothelial dysfunction Its clinical efficacy and safety have been described in the four randomized controlled trials of the SMILE program which globally enrolled more than 3600 patients in post acute myocardial infarction AMI setting The SMILE 4 study specifically selected patients with left ventricular dysfunction at admission and compared the effects of zofenopril or ramipril in combination with acetylsalicylic acid ASA Zofenopril demonstrated its superiority over ramipril in reducing the combined occurrence of death or hospitalization for cardiovascular causes both in the overall population included in the original study and in subgroups of patients at highest risk namely hypertensive and diabetic subjects The effects of the early treatment with zofenopril were sustained over time and after 5 years of follow up zofenopril increased the survival likelihood and reduced the hospitalization rate Compared to ramipril zofenopril was cost effective with a number to treat of 13 and an incremental cost effectiveness ratio ICER of 2125 45 euros for any additional event prevented Furthermore in real world settings zofenopril decreased the risk of death in patients with heart failure particularly in men and in subjects older than 76 years or with ejection fraction lower than 54 These results support the early use of zofenopril immediately after AMI even in the presence of comorbidities and its maintenance over time to reduce the risk of heart failure FUNDING Menarini International Operations Luxembourg S A