The Effect of the Angiotensin-ConvertingEnzyme Inhibitor Zofenopril on Mortality and Morbidity after Anterior Myocardial Infarction
Ettore Ambrosioni, M.D., Claudio Borghi, M.D., Bruno Magnani, M.D., for The Survival of Myocardial Infarction Long-Term Evaluation (SMILE) Study Investigators
Background Left ventricular dilatation and neuroendocrine activationare common after acute anterior myocardial infarction. Long-termtreatment with an angiotensin-convertingenzyme (ACE)inhibitor may improve outcome by attenuating these processes.We investigated whether the ACE inhibitor zofenopril, administeredfor six weeks after anterior myocardial infarction, could improveboth short-term and long-term outcome.
Methods A total of 1556 patients were enrolled within 24 hoursafter the onset of symptoms of acute anterior myocardial infarction,and they were randomly assigned in a double-blind fashion toreceive either placebo (784 patients) or zofenopril (772 patients)for six weeks. At this time we assessed the incidence of deathor severe congestive heart failure. The patients were reexaminedafter one year to assess survival.
Results The incidence of death or severe congestive heart failureat six weeks was significantly reduced in the zofenopril group(55 patients, 7.1 percent), as compared with the placebo group(83 patients, 10.6 percent); the cumulative reduction in therisk of death or severe congestive heart failure was 34 percent(95 percent confidence interval, 8 to 54 percent; P = 0.018).The reduction in risk was 46 percent (95 percent confidenceinterval, 11 to 71 percent; P = 0.018) for severe congestiveheart failure and 25 percent (95 percent confidence interval,-11 to 60 percent; P = 0.19) for death. After one year of observation,the mortality rate was significantly lower in the zofenoprilgroup (10.0 percent) than in the placebo group (14.1 percent);the reduction in risk was 29 percent (95 percent confidenceinterval, 6 to 51 percent; P = 0.011).
Conclusions Treatment with zofenopril significantly improvedboth short-term and long-term outcome when this drug was startedwithin 24 hours after the onset of acute anterior myocardialinfarction and continued for six weeks.
Source Information
From the Departments of Internal Medicine (E.A., C.B.) and Cardiology (B.M.), University of Bologna, Bologna, Italy.
Address reprint requests to Dr. Borghi at Clinica Medica 3rd, Policlinico S. Orsola, Via Massarenti 9, 40138 Bologna, Italy.
Zofenopril after Anterior Myocardial Infarction
Mörike K., Mikus G., Gurbel P. A., O'Connor C. M., Chaudhry G. M., Haneef N., Borghi C., Ambrosioni E., Magnani B., The SMILE Study Investigators
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N Engl J Med 1995;
332:1715-1716, Jun 22, 1995.
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