Efficacy of zofenopril in combination with amlodipine in patients with acute myocardial infarction: a pooled individual patient data analysis of four randomized, double-blind, controlled, prospective ...
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OBJECTIVE In the four SMILE Survival of Myocardial Infarction Long Term Evaluation studies early administration of zofenopril in acute myocardial infarction AMI showed beneficial effects as compared to placebo and other angiotensin converting enzyme inhibitors ACEIs We investigated whether the concomitant administration of the dihydropyridine calcium channel blocker amlodipine may improve zofenopril efficacy to prevent cardiovascular events in post AMI patients METHODS This was a post hoc analysis of pooled individual patient data from the four large randomized SMILE studies The primary endpoint was the 1 year combined occurrence of death or hospitalization for cardiovascular causes RESULTS 3488 patients were considered 303 8 7 treated with concomitant amlodipine Baseline systolic blood pressure and prevalence of metabolic syndrome were higher in amlodipine treated patients The 1 year occurrence of major cardiovascular outcomes was significantly reduced in patients receiving concomitant treatment with amlodipine hazard ratio HR and 95 confidence interval CI 0 66 95 CI 0 44 0 98 p 0 039 After accounting for treatment with amlodipine the risk of cardiovascular events was significantly reduced with zofenopril compared to placebo HR and 95 CI 0 78 0 63 0 97 p 0 026 Among ACEI treated patients the zofenopril plus amlodipine combination reduced the risk of cardiovascular events by 38 compared to the combination of other ACEIs plus amlodipine HR and 95 CI 0 76 0 61 0 94 p 0 013 The prognostic benefit of concomitant treatment with zofenopril plus amlodipine was independent from blood pressure lowering CONCLUSIONS Zofenopril had a positive impact on prognosis in post AMI patients compared to other ACEIs Concomitant administration of amlodipine may help to reduce the risk of cardiovascular events at 1 year