Zofenopril 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

Claudio Borghi, S. Omboni, Salvatore Novo, Dragos Vinereanu, G. A. Ambrosio, Ettore Ambrosioni, Alexopolulus Dimitrios, Nanas Ioannis, Agrusta Marco, Barsotti Antonio, Bergerone Serena, Caliendo Luigi, Caso Pio, Castello Antonio, Domenico Cianflone, Cipolla Tommaso, Gaetano De Ferrari, De Nittis Giuseppe, Dei Cas Livio, Di Pasquale PaoloEvola Rosario, Fattore Luciano, Ferrante Raffaele, Fiscella Antonio, Gaspardone Achille, Ielasi Giuseppe, Marchionni Niccoló, Marenzi Giancarlo, Marte Filippo, Miccoli Federico, Noussan Patrizia, Orlandi Mario, Piovaccari Giancarlo, Porcu Maurizio, Patrizia Presbitero, Raviele Antonio, Renaldini Emiliano, Salerno Uriarte Jorge, Storti Giovanni, Tamburino Corrado, Terrosu Pierfranco, Testa Roberto, Trinchero Rita, Tuccillo Bernardino, Vasquez Ludovico, Villani Giovanni Quinto, Alvés Mario Garcia, Andrade Aurora, Cardoso Silva, Moreira Joseà Ilidio, Arsenescu Georgescu Catalina, Cinteza Mircea, Dorobantu Maria, Ionescu Dominic, Manitiu Ioan, Ortan Florin, Pop Calin, Radoi Mariana, Alexandrovich Vasyuk Yuriy, Avenirovitch Kostenko Victor, Borisovich Karpov Yuriy, Iosifovna Tseluiko Vira, Lvovich Syrkin Abram, Mikhailovich Goloschekin Boris, Mikhaylovich Nifontov Evgeniy, Nikolaevich Tereschenko Sergey, Nikolaevna Burova Natalia, Nikolayevich Zrazhevsky Konstantin, Pavlovich Arutuynov Grigory, Sergeevich Moiseev Valentin, Victorovich Rudenko Leonid, Yurievich Vishnevsky Alexander, D. L Y De La Yera Diaz, Romero Fernández, Kirma Cevat, Meral Kayikcioglu, Oğuzhan Abdurrahman, Ural Komsuoglu Dilek, Ankindinovna Koval Olena, Nikolaevich Parkhomenko Alexan, Petrovich Vakalyuk Igor, Tihonovich Vatutin Mykola, Vladimirovich Batushkin Valerii

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)76-84
Number of pages9
JournalCardiovascular Therapeutics
Volume34
Issue number2
DOIs
Publication statusPublished - Apr 1 2016

Keywords

  • Acetyl salicylic acid
  • Acute myocardial infarction
  • Angiotensin-converting enzyme inhibitors
  • Diabetes mellitus
  • Left ventricular dysfunction
  • Ramipril
  • Zofenopril

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Pharmacology (medical)
  • Pharmacology

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