Open AccessZofenopril and Ramipril in Combination with Acetyl Salicylic Acid in Postmyocardial Infarction Patients with Left Ventricular Systolic Dysfunction: A Retrospective Analysis of the SMILE ‐4 Randomized, Double‐Blind Study in Diabetic Patients
Author(s) -
Borghi Claudio,
Omboni Stefano,
Novo Salvatore,
Vinereanu Dragos,
Ambrosio Giuseppe,
Ambrosioni Ettore
Publication year - 2016
Publication title -
cardiovascular therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.818
H-Index - 46
eISSN - 1755-5922
pISSN - 1755-5914
DOI - 10.1111/1755-5922.12175
Subject(s) - medicine , ramipril , diabetes mellitus , mace , myocardial infarction , cardiology , clinical endpoint , odds ratio , retrospective cohort study , randomized controlled trial , blood pressure , endocrinology , percutaneous coronary intervention
Summary Objective In the SMILE ‐4 study, zofenopril + acetyl salicylic acid ( ASA ) was more effective than ramipril + ASA on 1‐year prevention of major cardiovascular events ( MACE ) in patients with acute myocardial infarction complicated by left ventricular dysfunction. In this retrospective analysis, we evaluated drug efficacy in subgroups of patients, according to a history of diabetes mellitus. Methods The primary study endpoint was 1‐year combined occurrence of death or hospitalization for cardiovascular causes. Diabetes was defined according to medical history (previous known diagnosis). Results A total of 562 of 693 (81.0%) patients were classified as nondiabetics and 131 (18.9%) as diabetics. The adjusted rate of MACE was lower under zofenopril than under ramipril in both nondiabetics [27.9% vs. 34.9% ramipril; odds ratio, OR and 95% confidence interval: 0.55 (0.35, 0.86)] and diabetics [30.9% vs. 41.3%; 0.56 (0.18, 1.73)], although the difference was statistically significant only for the nondiabetic group ( P = 0.013). Zofenopril was superior to ramipril as regards to the primary study endpoint in the subgroup of 157 patients with uncontrolled blood glucose (≥126 mg/dL), regardless of a previous diagnosis of diabetes [0.31 (0.10, 0.90), P = 0.030]. Zofenopril significantly reduced the risk of hospitalization for cardiovascular causes in both nondiabetics [0.64 (0.43, 0.96), P = 0.030] and diabetics [0.38 (0.15, 0.95), P = 0.038], whereas it was not better than ramipril in terms of prevention of cardiovascular deaths. Conclusions This retrospective analysis of the SMILE ‐4 study confirmed the good efficacy of zofenopril plus ASA in the prevention of long‐term MACE also in the subgroup of patients with diabetes mellitus.