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.
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 / Borghi, Claudio; Omboni, Stefano; Novo, Salvatore; Vinereanu, Dragos; Ambrosio, Giuseppe; Ambrosioni, Ettore; Dimitrios, Alexopolulus; Ioannis, Nanas; Marco, Agrusta; Antonio, Barsotti; Serena, Bergerone; Luigi, Caliendo; Pio, Caso; Antonio, Castello; Domenico, Cianflone; Tommaso, Cipolla; Gaetano, De Ferrari; Giuseppe, De Nittis; Livio, Dei Cas; Paolo, Di Pasquale; Rosario, Evola; Luciano, Fattore; Raffaele, Ferrante; Antonio, Fiscella; Achille, Gaspardone; Giuseppe, Ielasi; Niccoló, Marchionni; Giancarlo, Marenzi; Filippo, Marte; Federico, Miccoli; Patrizia, Noussan; Mario, Orlandi; Giancarlo, Piovaccari; Maurizio, Porcu; Patrizia, Presbitero; Antonio, Raviele; Emiliano, Renaldini; Jorge, Salerno Uriarte; Giovanni, Storti; Corrado, Tamburino; Pierfranco, Terrosu; Roberto, Testa; Rita, Trinchero; Bernardino, Tuccillo; Ludovico, Vasquez; Quinto, Villani Giovanni; Garcia, Alvés Mario; Aurora, Andrade; Silva, Cardoso; Ilidio, Moreira Joseà; Catalina, Arsenescu Georgescu; Mircea, Cinteza; Maria, Dorobantu; Dominic, Ionescu; Ioan, Manitiu; Florin, Ortan; Calin, Pop; Mariana, Radoi; Yuriy, Alexandrovich Vasyuk; Victor, Avenirovitch Kostenko; Yuriy, Borisovich Karpov; Vira, Iosifovna Tseluiko; Abram, Lvovich Syrkin; Boris, Mikhailovich Goloschekin; Evgeniy, Mikhaylovich Nifontov; Sergey, Nikolaevich Tereschenko; Natalia, Nikolaevna Burova; Konstantin, Nikolayevich Zrazhevsky; Grigory, Pavlovich Arutuynov; Valentin, Sergeevich Moiseev; Leonid, Victorovich Rudenko; Alexander, Yurievich Vishnevsky; Diaz, D.L.Y.De La Yera; Fernández, Romero; Cevat, Kirma; Kayikcioglu, Meral; Abdurrahman, Oğuzhan; Dilek, Ural Komsuoglu; Olena, Ankindinovna Koval; Alexan, Nikolaevich Parkhomenko; Igor, Petrovich Vakalyuk; Mykola, Tihonovich Vatutin; Valerii, Vladimirovich Batushkin. - In: CARDIOVASCULAR THERAPEUTICS. - ISSN 1755-5914. - STAMPA. - 34:2(2016), pp. 76-84. [10.1111/1755-5922.12175]
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
BORGHI, CLAUDIO
Primo
Conceptualization
;AMBROSIONI, ETTORE;
2016
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
