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
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
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:.
Received for publication 19 November 2002 and accepted in revised form 25 January 2003.
C.B. and E.A. have received honoraria from the Menarini Company for speaking engagements on ACE inhibitors.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
- DIABETES CARE