Effects of the Early ACE Inhibition in Diabetic Nonthrombolyzed Patients With Anterior Acute Myocardial Infarction

Effects of the Early ACE Inhibition in Diabetic Nonthrombolyzed Patients With Anterior Acute Myocardial Infarction Claudio Borghi , MD , Stefano Bacchelli , MD , Daniela Degli Esposti , MD , Ettore Ambrosioni , MD and on behalf of the SMILE Study Investigators From the Department of Internal Medicine, University of Bologna, Bologna, Italy Abstract OBJECTIVE —The aim of the present study was to evaluate the clinical efficacy of the ACE inhibitor zofenopril in a cohort of diabetic patients with nonthrombolyzed anterior acute myocardial infarction who were enrolled in the Survival of Myocardial Infarction Long-Term Evaluation (SMILE) trial. RESEARCH DESIGN AND METHODS —Among the overall population of 1,512 patients, 303 (20.0%) had diabetes. The primary end point of this study was the effect of treatment on the 6-week combined occurrence of death and severe congestive heart failure (CHF). Secondary end points included the evaluation of the 6-week rate of major cardiovascular events as well as the 1-year survival rate. RESULTS —After 6 weeks of double-blind treatment, zofenopril significantly reduced both the incidence of the primary end point (8.6 vs. 18.3%; P = 0.019) and the 6-week incidence of severe CHF (0 vs. 7.3%; P = 0.001) in diabetic patients, and the effect was greater than that observed in nondiabetic patients. Conversely, 1-year mortality was significantly reduced among nondiabetic patients (9.1 vs. 13.8%; P = 0.010), whereas in the diabetic population, the decrease did not reach statistical significance (13.7 vs. 16.5%; P = 0.52). CONCLUSIONS —The present data suggest that the clinical outcome of patients with diabetes and myocardial infarction can be significantly improved by early treatment with zofenopril. The lesser effect on 1-year mortality seems to suggest that long-term treatment is probably needed to maintain the benefits of the early ACE inhibition in patients with diabetes. AMI, acute myocardial infarction CHF, congestive heart failure GISSI-3, Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico LV, left ventricular MI, myocardial infarction NNT, number needed to treat SMILE, Survival of Myocardial Infarction Long-term Evaluation TRACE, Trandolapril Cardiac Evaluation Footnotes Address correspondence and reprint requests to Claudio Borghi, MD, Divisione di Medicina Interna-Ambrosioni, Policlinico S. Orsola Via Massarenti 9, 40138 Bologna, Italy. E-mail: claudio{at}med.unibo.it . Received for publication 19 Novembe