title: Early Treatment With Zofenopril and Ramipril in Combination With Acetyl Salicylic Acid in Patients With Left Ventricular Systolic Dysfunction After Acute Myocardial Infarction: Results of a 5-Year Follow-up of Patients of the SMILE-4 Study.
abstract: The SMILE-4 study showed that in patients with left ventricular dysfunction (LVD) after acute myocardial infarction, early treatment with zofenopril plus acetyl salicylic acid is associated with an improved 1-year survival, free from death or hospitalization for cardiovascular (CV) causes, as compared to ramipril plus acetyl salicylic acid. We now report CV outcomes during a 5-year follow-up of the patients of the SMILE-4 study. Three hundred eighty-six of the 518 patients completing the study (51.2%) could be tracked after the study end and 265 could be included in the analysis. During the 5.5 (±2.1) years of follow-up, the primary endpoint occurred in 27.8% of patients originally randomized and treated with zofenopril and in 43.8% of patients treated with ramipril [odds ratio (OR) and 95% confidence interval, 0.65 (0.43-0.98), P = 0.041]. Such a result was achieved through a significantly larger reduction in CV hospitalization under zofenopril [OR: 0.61 (0.37-0.99), P = 0.047], whereas reduction in mortality rate with zofenopril did not achieve statistical significance versus ramipril [OR: 0.75 (0.36-1.59), P = 0.459]. These results were in line with those achieved during the initial 1-year follow-up. Benefits of early treatment of patients with LVD after acute myocardial infarction with zofenopril are sustained over many years as compared to ramipril.
authors.affiliation: *Unit of Internal Medicine, Policlinico S. Orsola, University of Bologna, Bologna, Italy; †Clinical Research Unit, Italian Institute of Telemedicine, Varese, Italy; ‡Division of Cardiology, University of Palermo, Palermo, Italy; §Department of Cardiology, University and Emergency Hospital, Bucharest, Romania; and ¶Division of Cardiology, University of Perugia, Perugia, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Borghi
authors.forename: Stefano
authors.initials: S
authors.lastname: Omboni
authors.forename: Salvatore
authors.initials: S
authors.lastname: Novo
authors.forename: Dragos
authors.initials: D
authors.lastname: Vinereanu
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Ambrosio
authors.forename: Ettore
authors.initials: E
authors.lastname: Ambrosioni
mesh_terms: D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D002216:Captopril / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016009:Chi-Square Distribution; D017326:Clinical Trials, Phase III as Topic; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D061345:Early Medical Intervention; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications*; D016017:Odds Ratio; D017257:Ramipril / Q000008:administration & dosage* / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D020127:Recovery of Function; D012189:Retrospective Studies; D012307:Risk Factors; D013599:Systole; D013997:Time Factors; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D016277:Ventricular Function, Left / Q000187:drug effects*
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; C044958:zofenopril; D002216:Captopril; D017257:Ramipril; D001241:Aspirin